ID

11796

Descrizione

Breast Cancer NCT00684983 Eligibility - NCCTG N0733 Eligibility Checklist - 2777789v1.0 NCCTG N0733 Eligibility Checklist Capecitabine and Lapatinib With or Without Cixutumumab in Treating Patients With Previously Treated HER2-Positive Stage IIIB, Stage IIIC, or Stage IV Breast Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=555F4502-A448-6B03-E044-0003BA3F9857

collegamento

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=555F4502-A448-6B03-E044-0003BA3F9857

Keywords

versioni (6)
  1. 26/08/12 26/08/12 -
  2. 09/01/15 09/01/15 - Martin Dugas
  3. 09/01/15 09/01/15 - Martin Dugas
  4. 04/08/15 04/08/15 - Martin Dugas
  5. 04/08/15 04/08/15 - Martin Dugas
  6. 20/09/21 20/09/21 -
Caricato su

4 agosto 2015

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY-NC 3.0 Legacy
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Eligibility Breast Cancer NCCTG N0733 NCT00684983

Inglese

First 10 patients only: Prior to discussing this protocol with the patient call the CTSU office 1-888-462-3009 to see if there is a place available for your patient.

1 moduli  
Header
Descrizione

Header

NCCTG Patient ID (provided at time of Reg/Random)
Descrizione

PatientNorthCentralCancerTreatmentGroupIdentifierNumber

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property-2
C25581
UMLS 2011AA Property-2
C1518419
Patient Hospital No.
Descrizione

Medical Record Number

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C1301894
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25261
NCI Thesaurus Property-2
C25198
Participating Group Code (Cooperative Group where credit will be applied)
Descrizione

ParticipatingGroupIdentifierCode

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25162
UMLS 2011AA ValueDomain
C0805701
NCI Thesaurus ObjectClass
C25608
UMLS 2011AA ObjectClass
C0679823
NCI Thesaurus ObjectClass-2
C17005
UMLS 2011AA ObjectClass-2
C1257890
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Institution Name (treating location/performance site)
Descrizione

Institution Name

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C1301943
NCI Thesaurus ObjectClass
C21541
NCI Thesaurus ValueDomain-2
C21541
NCI Thesaurus Property
C25364
Institution Code (CTEP assigned number)
Descrizione

NationalCancerInstituteInstituteCode

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25162
UMLS 2011AA ValueDomain
C0805701
NCI Thesaurus ObjectClass
C21541
UMLS 2011AA ObjectClass
C0018704
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Physician of Record
Descrizione

PhysicianPerformingImagingSeriesName

Tipo di dati

text

Alias
NCI Thesaurus ObjectClass
C25674
UMLS 2011AA ObjectClass
C0205549
NCI Thesaurus ObjectClass-2
C18843
UMLS 2011AA ObjectClass-2
C1704382
NCI Thesaurus Property
C25741
UMLS 2011AA Property
C0031831
NCI Thesaurus Property-2
C38000
UMLS 2011AA Property-2
C0884358
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
IRB/REB Approval Date (mm/dd/yyyy)
Descrizione

IRB Approval Date

Tipo di dati

date

Alias
NCI Thesaurus ObjectClass
C25320
UMLS CUI-1
C2346500
NCI Thesaurus Property
C16741
NCI Thesaurus Property-2
C25425
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ValueDomain-2
C25367
Date of Registration (mm/dd/yyyy)
Descrizione

PatientRegistrationDate

Tipo di dati

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus Property
C25646
UMLS 2011AA Property
C1514821
Last name
Descrizione

Person Completing Form Last Name

Tipo di dati

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS CUI-1
C1550483
NCI Thesaurus ObjectClass-2
C25657
UMLS CUI-2
C1301584
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25551
NCI Thesaurus ValueDomain
C25191
First Name
Descrizione

Person Completing Form First Name

Tipo di dati

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS CUI-1
C1550483
NCI Thesaurus ObjectClass-2
C25657
UMLS CUI-2
C1443235
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25509
NCI Thesaurus ValueDomain
C25191
Phone
Descrizione

Person Completing Form Phone

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C1550483
NCI Thesaurus ObjectClass
C25190
UMLS CUI-2
C1515258
NCI Thesaurus ObjectClass-2
C25657
NCI Thesaurus Property
C25395
Fax
Descrizione

ResponsiblePersonFaxNumber

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus ObjectClass-2
C25657
UMLS 2011AA ObjectClass-2
C1273518
NCI Thesaurus Property
C25210
UMLS 2011AA Property
C0085205
E-mail
Descrizione

ResponsiblePersonE-mailAddressText

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C25657
UMLS 2011AA ObjectClass
C1273518
NCI Thesaurus Property
C42775
UMLS 2011AA Property
C1705961
Patient Demographics / Pre-treatment Characteristics
Descrizione

Patient Demographics / Pre-treatment Characteristics

Last
Descrizione

Patient Initials Last

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C1517741
NCI Thesaurus Property
C25536
NCI Thesaurus Property-2
C25551
First
Descrizione

Patient Initials First

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C0205435
NCI Thesaurus Property
C25536
NCI Thesaurus Property-2
C25509
Middle
Descrizione

PatientMiddleInitialsName

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25536
UMLS 2011AA Property
C1555582
NCI Thesaurus Property-2
C25569
UMLS 2011AA Property-2
C0444598
Gender
Descrizione

Gender

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25372
UMLS CUI-1
C0079399
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C17357
Ethnicity (U.S. and Canada only)
Descrizione

Ethnic Group

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25372
UMLS CUI-1
C0015031
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C16564
Patient's Date of Birth (mm/dd/yyyy)
Descrizione

Patient Birth Date

Tipo di dati

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C0421451
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus Property
C25155
Patient Zip Code
Descrizione

PatientAddressPostalCode

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25162
UMLS 2011AA ValueDomain
C0805701
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25407
UMLS 2011AA Property
C1442065
Country of residence
Descrizione

PatientAddressCountryCode

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25162
UMLS 2011AA ValueDomain
C0805701
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25407
UMLS 2011AA Property
C1442065
Method of Payment (check oneUSA only)
Descrizione

PatientPaymentType

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25371
UMLS 2011AA Property
C0680264
Race
Descrizione

Race

Race
Descrizione

Racial Group

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25372
UMLS CUI-1
C0034510
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C17049
Pre-treatment Requirements
Descrizione

Pre-treatment Requirements

Women or men >=18 years of age
Descrizione

PatientAgeInd-2

Tipo di dati

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25150
UMLS 2011AA Property
C0001779
Age
Descrizione

PatientAgeYearCount

Tipo di dati

float

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ValueDomain
C29848
UMLS 2011AA ValueDomain
C0439234
NCI Thesaurus ValueDomain-2
C25463
UMLS 2011AA ValueDomain-2
C0750480
NCI Thesaurus Property
C25150
UMLS 2011AA Property
C0001779
Histologically confirmed, locally advanced (a T4 primary tumor and stage IIIB or IIIC disease) or metastatic breast cancer that has progressed after treatment with regimens that included trastuzumab and either an anthracycline or a taxane or both. (NOTE: Agents need not have been given concurrently nor in the same regimen. NOTE: Prior treatment with trastuzumab is required unless there is a contraindication for trastuzumab treatment.)
Descrizione

PatientNorthCentralCancerTreatmentGroupAdvancedBreastCarcinomaCancerProgressionEligibilityDeterminationInd-2

Tipo di dati

boolean

Alias
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25581
NCI Thesaurus Property-2
C25411
NCI Thesaurus Property-3
C4872
NCI Thesaurus Property-4
C25171
NCI Thesaurus Property-5
C19987
NCI Thesaurus ValueDomain
C38147
UMLS CUI [1,1]
C0205179
UMLS CUI [1,2]
C0678222
Prior treatment with trastuzumab in the neo-adjuvant, adjuvant, or metastatic setting is required. (NOTE: Prior treatment with trastuzumab is required unless there is a contraindication for trastuzumab treatment. - NOTE: Concomitant use of trastuzumab is not allowed in this study.)
Descrizione

PatientPriorTrastuzumabTaxaneCompoundAdjuvantTherapyEligibilityDeterminationEligibilityInd-2

Tipo di dati

boolean

Alias
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C1647
NCI Thesaurus Property-2
C25629
NCI Thesaurus Property-3
C15675
NCI Thesaurus Property-4
C25171
NCI Thesaurus Property-5
C1490
NCI Thesaurus ValueDomain
C38147
UMLS CUI [1]
C0338204
Prior chemotherapy allowed in the neo-adjuvant, adjuvant, or metastatic setting. Unlimited prior chemotherapy is allowed.
Descrizione

PriorBreastCarcinomaChemotherapyAdministeredIndicator

Tipo di dati

boolean

Alias
NCI Thesaurus ObjectClass
C15632
UMLS 2011AA ObjectClass
C0392920
NCI Thesaurus ObjectClass-2
C25629
UMLS 2011AA ObjectClass-2
C0332152
NCI Thesaurus ObjectClass-3
C4872
UMLS 2011AA ObjectClass-3
C0678222
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
Prior hormonal therapy allowed in the neo-adjuvant, adjuvant, or metastatic setting. Unlimited prior hormonal therapy is allowed.
Descrizione

PatientBreastCarcinomaEndocrineTherapyAdministeredEligibilityDeterminationInd-2

Tipo di dati

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C15445
UMLS 2011AA Property
C0279025
NCI Thesaurus Property-2
C4872
UMLS 2011AA Property-2
C0678222
NCI Thesaurus Property-3
C25171
UMLS 2011AA Property-3
C0013893
NCI Thesaurus Property-4
C25382
UMLS 2011AA Property-4
C1521801
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
HER2 positive, defined as: Validated IHC assay score of 3+ (defined as uniform, intense staining of >30% of invasive tumor cells) -OR- Average HER2 gene copy number of >6 -OR- Gene amplified (HER2:D17Z1) ratio >2.20
Descrizione

PatientHER2/neuPositiveFindingEligibilityDeterminationInd-2

Tipo di dati

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C38758
UMLS 2011AA Property
C1514241
NCI Thesaurus Property-2
C25171
UMLS 2011AA Property-2
C0013893
NCI Thesaurus Property-3
C17756
UMLS 2011AA Property-3
C0242957
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Must have measurable disease according to RECIST criteria (See Section 11.0)
Descrizione

PatientMeasurableDiseaseResponseEvaluationCriteriainSolidTumorsEligibilityDeterminationInd-2

Tipo di dati

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C8507
UMLS 2011AA Property
C1513041
NCI Thesaurus Property-2
C25171
UMLS 2011AA Property-2
C0013893
NCI Thesaurus Property-3
C49164
UMLS 2011AA Property-3
C1709926
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Negative pregnancy test done <=7 days prior to registration, for women of childbearing potential only. (If not a woman of childbearing potential check NA)
Descrizione

PatientNegativePregnancyTestIndicator

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25247
UMLS 2011AA Property
C0205160
NCI Metathesaurus Property
C0032976
Negative pregnancy test date (If a woman of childbearing potential)
Descrizione

PatientNegativePregnancyTestDate

Tipo di dati

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25247
UMLS 2011AA Property
C0205160
NCI Metathesaurus Property
C0032976
The following laboratory values obtained <=7 days prior to registration
Descrizione

PatientPriorRegistrationLaboratoryProcedureEligibilityDeterminationInd-2

Tipo di dati

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25646
UMLS 2011AA Property
C1514821
NCI Thesaurus Property-2
C25629
UMLS 2011AA Property-2
C0332152
NCI Thesaurus Property-3
C25294
UMLS 2011AA Property-3
C0022885
NCI Thesaurus Property-4
C25171
UMLS 2011AA Property-4
C0013893
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Earliest laboratory test date (Note: These dates pertain to the following labs only.)
Descrizione

LaboratoryProcedureEvaluationPerformedFirstDate

Tipo di dati

date

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C25214
UMLS 2011AA Property
C0220825
NCI Thesaurus Property-2
C38000
UMLS 2011AA Property-2
C0884358
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25509
UMLS 2011AA ValueDomain-2
C1279901
latest laboratory test date
Descrizione

LaboratoryProcedureEvaluationPerformedMostRecentDate

Tipo di dati

date

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C25214
UMLS 2011AA Property
C0220825
NCI Thesaurus Property-2
C38000
UMLS 2011AA Property-2
C0884358
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25577
UMLS 2011AA ValueDomain-2
C1513491
Hemoglobin >9.0 g/dL
Descrizione

HematologyHemoglobinAssessmentInd-2

Tipo di dati

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus ObjectClass
C16673
UMLS 2011AA ObjectClass
C0018943
Hemoglobin
Descrizione

Hemoglobin

Tipo di dati

float

Unità di misura
  • g/dL
Alias
NCI Thesaurus Property
C16676
UMLS CUI-1
C0019046
NCI Thesaurus Property-2
C20200
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus ValueDomain
C25712
g/dL
WBC >= 3,000/mL
Descrizione

LaboratoryProcedureLeukocyteEligibilityDeterminationInd-2

Tipo di dati

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C12529
UMLS 2011AA Property
C0023516
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property-2
C25171
UMLS 2011AA Property-2
C0013893
WBC
Descrizione

Leukocytes (WBC)

Tipo di dati

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS CUI-1
C0023508
NCI Thesaurus Property
C12529
NCI Thesaurus Property-2
C20200
NCI Thesaurus ValueDomain
C38046
NCI Thesaurus ValueDomain-2
C25712
ANC >= 1500/mL
Descrizione

LaboratoryProcedureAbsoluteNeutrophilCountEligibilityDeterminationInd-2

Tipo di dati

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C63321
UMLS 2011AA Property
C0948762
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property-2
C25171
UMLS 2011AA Property-2
C0013893
ANC
Descrizione

ANC

Tipo di dati

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS CUI-1
C0948762
NCI Thesaurus Property
C20200
NCI Thesaurus Property-2
C63321
NCI Thesaurus ValueDomain
C38046
NCI Thesaurus ValueDomain-2
C25712
Platelet Count >= 75,000/mL
Descrizione

LaboratoryProcedurePlateletCountEligibilityDeterminationInd-2

Tipo di dati

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C51951
UMLS 2011AA Property
C0032181
NCI Thesaurus Property-2
C25171
UMLS 2011AA Property-2
C0013893
Platelet count
Descrizione

Platelets

Tipo di dati

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS CUI-1
C0005821
NCI Thesaurus Property
C20200
NCI Thesaurus Property-2
C12520
NCI Thesaurus ValueDomain
C38046
NCI Thesaurus ValueDomain-2
C25712
Total bilirubin <= 1.5 x ULN
Descrizione

LaboratoryProcedureWithinClinicalStudyProtocolUpperLimitofNormalTotalBilirubinMeasurementInd-2

Tipo di dati

boolean

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C25320
UMLS 2011AA Property
C1507394
NCI Thesaurus Property-2
C38037
UMLS 2011AA Property-2
C0201913
NCI Thesaurus Property-3
C25282
UMLS 2011AA Property-3
C0332285
NCI Thesaurus Property-4
C25706
UMLS 2011AA Property-4
C1519815
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Total Bilirubin
Descrizione

Bilirubin, Total

Tipo di dati

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS CUI-1
C0201913
NCI Thesaurus Property
C20200
NCI Thesaurus Property-2
C38037
NCI Thesaurus ValueDomain
C38046
NCI Thesaurus ValueDomain-2
C25712
Total Bilirubin ULN
Descrizione

Bilirubin, Total ULN

Tipo di dati

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS CUI-1
C0201913
NCI Thesaurus Property
C20200
UMLS CUI-2
C1519815
NCI Thesaurus Property-2
C38037
NCI Thesaurus ValueDomain
C25712
NCI Thesaurus ValueDomain-2
C25706
SGOT(AST) and SGPT(ALT) <=2.5 x ULN or SGOT(AST) and SGPT(ALT) <5 x ULN if elevations are due to liver metastases.
Descrizione

LaboratoryProcedureSerumGlutamicPyruvicTransaminaseSerumGlutamicOxaloaceticTransferaseEligibilityDeterminationInd-2

Tipo di dati

boolean

Alias
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus Property
C25202
NCI Thesaurus Property-2
C25171
NCI Thesaurus Property-3
C25293
NCI Thesaurus ValueDomain
C38147
UMLS CUI [1,1]
C0242192
UMLS CUI [1,2]
C0376147
SGOT(AST) and SGPT(ALT) >2.5 x ULN due to liver metastases (This question may be answered "Yes" or "No")
Descrizione

LaboratoryProcedureSerumGlutamicPyruvicTransaminaseSerumGlutamicOxaloaceticTransferaseMetastaticMalignantNeoplasmtotheLiverEligibilityDeterminationInd-2

Tipo di dati

boolean

Alias
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus Property
C25202
NCI Thesaurus Property-2
C25171
NCI Thesaurus Property-3
C25293
NCI Thesaurus Property-4
C4758
NCI Thesaurus ValueDomain
C38147
UMLS CUI [1,1]
C0242192
UMLS CUI [1,2]
C0376147
UMLS CUI [1,3]
C0494165
AST (SGOT)
Descrizione

AST (SGOT)

Tipo di dati

float

Unità di misura
  • U/L
Alias
NCI Thesaurus Property
C25202
NCI Thesaurus Property-2
C20200
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus ValueDomain
C25712
UMLS CUI [1]
C0201899
U/L
AST (SGOT) ULN
Descrizione

AST (SGOT) ULN

Tipo di dati

float

Unità di misura
  • U/L
Alias
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus Property
C25202
NCI Thesaurus Property-2
C20200
NCI Thesaurus ValueDomain
C25712
NCI Thesaurus ValueDomain-2
C25706
UMLS CUI [1,1]
C0242192
UMLS CUI [1,2]
C1519815
U/L
ALT (SGPT)
Descrizione

ALT (SGPT)

Tipo di dati

float

Unità di misura
  • U/L
Alias
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus Property
C20200
NCI Thesaurus Property-2
C25293
NCI Thesaurus ValueDomain
C38046
NCI Thesaurus ValueDomain-2
C25712
UMLS CUI [1]
C0201836
U/L
ALT (SGPT) ULN
Descrizione

ALT (SGPT) ULN

Tipo di dati

float

Unità di misura
  • U/L
Alias
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus Property
C20200
NCI Thesaurus Property-2
C25293
NCI Thesaurus ValueDomain
C25712
NCI Thesaurus ValueDomain-2
C25706
UMLS CUI [1,1]
C0376147
UMLS CUI [1,2]
C1519815
U/L
Serum Creatinine <=1.5 x ULN
Descrizione

LaboratoryProcedureCreatinineEligibilityDeterminationind-2

Tipo di dati

boolean

Alias
NCI Thesaurus ValueDomain
C38147
NCI Thesaurus Property
C399
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus Property-2
C25171
UMLS CUI [1]
C0010294
Creatinine
Descrizione

Creatinine

Tipo di dati

float

Unità di misura
  • mg/dL
Alias
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus Property
C20200
NCI Thesaurus Property-2
C399
NCI Thesaurus ValueDomain
C38046
NCI Thesaurus ValueDomain-2
C25712
UMLS CUI [1]
C0201976
mg/dL
Serum Creatinine ULN
Descrizione

Creatinine, serum ULN

Tipo di dati

float

Unità di misura
  • mg/dL
Alias
NCI Thesaurus ObjectClass
C25294
UMLS CUI-1
C0201976
NCI Thesaurus Property
C20200
UMLS CUI-2
C1519815
NCI Thesaurus Property-2
C399
NCI Thesaurus ValueDomain
C25712
NCI Thesaurus ValueDomain-2
C25706
mg/dL
Creatinine clearance >=30 mL/min (calculated according to Cockcroft and Gault - see Appendix II)
Descrizione

LaboratoryProcedureCreatinineClearanceEligibilityDeterminationInd-2

Tipo di dati

boolean

Alias
NCI Thesaurus ValueDomain
C38147
NCI Thesaurus Property
C25747
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus Property-2
C25171
UMLS CUI [1]
C0373595
Creatinine Clearance
Descrizione

Creatinine Clearance (NOTE: In patients with moderate renal impairment calculated creatinine clearance 30-50 mL/min at baseline, a dose reduction to 80% of the capecitabine starting dose is required. See Section 8.0.)

Tipo di dati

float

Unità di misura
  • mL/min
Alias
NCI Thesaurus Property
C20200
NCI Thesaurus Property-2
C25747
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus ValueDomain
C25712
UMLS CUI [1]
C0373595
mL/min
Fasting glucose <120 mg/dL (NOTE: Patients with diabetes are allowed to participate, provided that their blood glucose is within the guidelines above upon enrollment.)
Descrizione

LaboratoryProcedureFastingPlasmaGlucoseMeasurementEligibilityDeterminationInd-2

Tipo di dati

boolean

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C41376
UMLS 2011AA Property
C0202042
NCI Thesaurus Property-2
C25171
UMLS 2011AA Property-2
C0013893
NCI Thesaurus Property-3
C63663
UMLS 2011AA Property-3
C0015663
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Fasting glucose
Descrizione

Fasting glucose

Tipo di dati

float

Unità di misura
  • mg/dL
Alias
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus Property
C20200
NCI Thesaurus Property-2
C41376
NCI Thesaurus Property-3
C63663
NCI Thesaurus ValueDomain
C25712
UMLS CUI [1]
C0202045
mg/dL
International Normalization Ratio (INR) <= 1.5 X ULN
Descrizione

LaboratoryProcedureInternationalNormalizedRatioEligibilityDeterminationInd-2

Tipo di dati

boolean

Alias
NCI Thesaurus ValueDomain
C38147
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus Property
C25352
NCI Thesaurus Property-2
C25171
UMLS CUI [1]
C0525032
International Normalization Ratio (INR)
Descrizione

INR

Tipo di dati

float

Alias
NCI Thesaurus Property
C20200
UMLS CUI-1
C0525032
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus Property-2
C25352
NCI Thesaurus ValueDomain
C25712
International Normalized Ratio ULN
Descrizione

LaboratoryProcedureInternationalNormalizationRatioResultUpperLimitofNormalValue

Tipo di dati

float

Alias
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus Property
C20200
NCI Thesaurus Property-2
C25352
NCI Thesaurus ValueDomain
C25712
NCI Thesaurus ValueDomain-2
C25706
UMLS CUI [1,1]
C0525032
UMLS CUI [1,2]
C1519815
ECOG performance status 0, 1, or 2
Descrizione

EasternCooperativeOncologyGroupPerformanceStatusAssessmentInd-2

Tipo di dati

boolean

Alias
NCI Thesaurus ValueDomain
C38147
NCI Thesaurus Property
C20989
NCI Thesaurus ObjectClass
C25491
NCI Metathesaurus ObjectClass
CL092952
UMLS CUI [1]
C1512162
Performance Status
Descrizione

ECOG Performance Status

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS CUI-1
C1520224
NCI Thesaurus Property
C25367
NCI Thesaurus ValueDomain-2
C25491
NCI Thesaurus ObjectClass
C20641
Adequate cardiac function as defined as an ejection fraction 50% as determined by MUGA or echocardiogram
Descrizione

PatientCardiacFunctionRequiredInd-2

Tipo di dati

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25518
UMLS 2011AA Property
C0542341
Life expectancy >3 months
Descrizione

PatientLifeExpectancyEligibilityDeterminationInd-2

Tipo di dati

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C37987
UMLS 2011AA Property
C0376558
NCI Thesaurus Property-2
C25171
UMLS 2011AA Property-2
C0013893
NCI Thesaurus Property-3
C25359
UMLS 2011AA Property-3
C0679138
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Has written informed consent been obtained
Descrizione

Consent signed

Tipo di dati

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS CUI-1
C0742766
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25678
NCI Thesaurus Property-2
C25460
Willingness to return to an NCCTG or other participating cooperative group institution for treatment and follow-up
Descrizione

PatientTherapeuticProcedureFollow-upEligibilityDeterminationInd-2

Tipo di dati

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C16033
UMLS 2011AA Property
C1522577
NCI Thesaurus Property-2
C49236
UMLS 2011AA Property-2
C0087111
NCI Thesaurus Property-3
C25171
UMLS 2011AA Property-3
C0013893
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Patient willing to provide tissue and blood samples for research purposes (see Sections 6.0 14.0 and 17.0)
Descrizione

PersonSpecimenUseConsentEligibilityDeterminationIndicator

Tipo di dati

boolean

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C19157
UMLS 2011AA Property
C0370003
NCI Thesaurus Property-2
C25171
UMLS 2011AA Property-2
C0013893
NCI Thesaurus Property-3
C25460
UMLS 2011AA Property-3
C1511481
NCI Thesaurus Property-4
C25340
UMLS 2011AA Property-4
C0457083
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
Availability of diagnostic material (i.e., diagnostic slides confirming locally advanced/metastatic disease and HER2 stained slides) and operative and pathology reports from diagnosis of locally advanced or metastatic breast cancer (NOTE: Biopsy of recurrent disease and submission of these materials is not required if materials available from initial diagnosis of locally advanced/metastatic disease.)
Descrizione

EvaluationDiagnosticSpecimenPathologyReportEligibilityDeterminationind-2

Tipo di dati

boolean

Alias
NCI Thesaurus ObjectClass
C25214
UMLS 2011AA ObjectClass
C0220825
NCI Thesaurus ObjectClass-2
C25482
UMLS 2011AA ObjectClass-2
C0348026
NCI Thesaurus Property
C28277
UMLS 2011AA Property
C0807321
NCI Thesaurus Property-2
C19157
UMLS 2011AA Property-2
C0370003
NCI Thesaurus Property-3
C25171
UMLS 2011AA Property-3
C0013893
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Ability to complete questionnaire(s) by themselves or with assistance (All responses in above section must be "Yes" unless specified as "NA.")
Descrizione

PatientQuestionnaireCompleteEligibilityDeterminationInd-2

Tipo di dati

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25250
UMLS 2011AA Property
C0205197
NCI Thesaurus Property-2
C17048
UMLS 2011AA Property-2
C0034394
NCI Thesaurus Property-3
C25171
UMLS 2011AA Property-3
C0013893
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Exclusion Criteria
Descrizione

Exclusion Criteria

Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus newborn are unknown: - Pregnant women - Nursing women - Men or women of childbearing potential who are unwilling to employ adequate contraception (as determined by the treating physician).
Descrizione

PatientReproductionPregnancyBreastFeedingExclusionCriteriaInd-2

Tipo di dati

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25742
UMLS 2011AA Property
C0032961
NCI Thesaurus Property-2
C25370
UMLS 2011AA Property-2
C0680251
NCI Thesaurus Property-3
C25596
UMLS 2011AA Property-3
C0006147
NCI Thesaurus Property-4
C17087
UMLS 2011AA Property-4
C0035150
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Stage III or IV invasive cancer, other than breast cancer, in <=5 years prior to registration.
Descrizione

PatientAdvancedMalignantNeoplasmPriorRegistrationEligibilityDeterminationInd-2

Tipo di dati

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25646
UMLS 2011AA Property
C1514821
NCI Thesaurus Property-2
C25411
UMLS 2011AA Property-2
C0205179
NCI Thesaurus Property-3
C9305
UMLS 2011AA Property-3
C0006826
NCI Thesaurus Property-4
C25629
UMLS 2011AA Property-4
C0332152
NCI Thesaurus Property-5
C25171
UMLS 2011AA Property-5
C0013893
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Actively being treated for other malignancy, excepting non-melanotic skin cancer or carcinoma-in-situ of the cervix (If there is a history of prior malignancy, they must not be receiving other specific treatment for their cancer.)
Descrizione

PatientCurrentTherapeuticProcedureMalignantNeoplasmExclusionCriteriaInd-2

Tipo di dati

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25471
UMLS 2011AA Property
C0521116
NCI Thesaurus Property-2
C9305
UMLS 2011AA Property-2
C0006826
NCI Thesaurus Property-3
C49236
UMLS 2011AA Property-3
C0087111
NCI Thesaurus Property-4
C25370
UMLS 2011AA Property-4
C0680251
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
New York Heart Association class III or IV cardiovascular disease
Descrizione

PatientNewYorkHeartAssociationClassIII/IVEligibilityDeterminationInd-2

Tipo di dati

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25171
UMLS 2011AA Property
C0013893
NCI Thesaurus Property-2
C7922
UMLS 2011AA Property-2
C0278962
Current, active hepatic or biliary disease except Gilbert's syndrome or asymptomatic gallstones
Descrizione

PatientCurrentHepaticDisorderBiliaryDiseaseorDisorderExclusionCriteriaInd-2

Tipo di dati

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25471
UMLS 2011AA Property
C0521116
NCI Thesaurus Property-2
C2991
UMLS 2011AA Property-2
C0012634
NCI Thesaurus Property-3
C3196
UMLS 2011AA Property-3
C0023895
NCI Thesaurus Property-4
C25370
UMLS 2011AA Property-4
C0680251
NCI Thesaurus Property-5
C28011
UMLS 2011AA Property-5
C0521378
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Evidence of active brain metastasis including leptomeningeal involvement. CNS metastasis controlled by prior surgery and/or radiotherapy is allowed. (NOTE: To be considered controlled, there must be at least 2 months of no symptoms or evidence of progression prior to study entry and corticosteriod therapy must have been discontinued.)
Descrizione

PatientMetastaticMalignantNeoplasmtotheBrainExclusionCriteriaInd-2

Tipo di dati

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C3813
UMLS 2011AA Property
C0220650
NCI Thesaurus Property-2
C25370
UMLS 2011AA Property-2
C0680251
Major surgery, chemotherapy, or immunologic therapy <=6 weeks prior to registration
Descrizione

PatientSurgicalProcedureChemotherapyImmunotherapyPriorRegistrationExclusionCriteriaInd-2

Tipo di dati

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25646
UMLS 2011AA Property
C1514821
NCI Thesaurus Property-2
C15632
UMLS 2011AA Property-2
C0392920
NCI Thesaurus Property-3
C15262
UMLS 2011AA Property-3
C0021083
NCI Thesaurus Property-4
C15329
UMLS 2011AA Property-4
C0543467
NCI Thesaurus Property-5
C25629
UMLS 2011AA Property-5
C0332152
NCI Thesaurus Property-6
C25370
UMLS 2011AA Property-6
C0680251
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Radiotherapy <=4 weeks prior to registration, except if to a non-target lesion only. Prior radiation to a target lesion is permitted only if there has been clear progression of the lesion since radiation was completed. (If patient receives single dose radiation for palliation or radiation to non-target lesion, they may immediately proceed to registration without waiting 4 weeks. Acute adverse events from radiation must have resolved to <=CTCAE v3.0 Grade 1.)
Descrizione

PatientRadiationTherapyPriorRegistrationExclusionCriteriaInd-2

Tipo di dati

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25646
UMLS 2011AA Property
C1514821
NCI Thesaurus Property-2
C15313
UMLS 2011AA Property-2
C1522449
NCI Thesaurus Property-3
C25629
UMLS 2011AA Property-3
C0332152
NCI Thesaurus Property-4
C25370
UMLS 2011AA Property-4
C0680251
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Prior treatment with any therapy targeting IGF-I, IGF-II or its receptors(either monoclonal antibody or tyrosine kinase inhibitor), including but not limited to any of the following (which would have been received on a previous clinical trial): - IMC-A12 (cixutumumab) - CP-751,871 (figitumumab) - AMG-479 - INSM-18 - MK0646 (h7C10) - SCH717454 (19D12, robatumumab) - R1507 - OSI-906 - BMS-754807 - PPP - NVP-AEW541 - AVE-1642 - MEDI-573
Descrizione

PatientInsulin-LikeGrowthFactorTherapeuticProcedureExclusionCriteriaInd-2

Tipo di dati

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C49236
UMLS 2011AA Property
C0087111
NCI Thesaurus Property-2
C25370
UMLS 2011AA Property-2
C0680251
NCI Thesaurus Property-3
C20442
UMLS 2011AA Property-3
C0037657
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Prior therapy with any therapy targeting HER1 (EGFR) and/or HER2 (either monoclonal antibody or tyrosine kinase) other than trastuzumab, including but not limited to any of the following: (lapatinib Tykerb, gefitinib Iressa, erlotinib Tarveca, cetuximab Erbitux, panitumumab Vectibix)
Descrizione

PatientEpidermalGrowthFactorReceptorERBB2ReceptorProtein-TyrosineKinaseTherapeuticProcedureExclusionCriteriaInd-2

Tipo di dati

boolean

Alias
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C49236
NCI Thesaurus Property-2
C17068
NCI Thesaurus Property-3
C25370
NCI Thesaurus Property-4
C17319
NCI Thesaurus ValueDomain
C38147
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0034802
UMLS CUI [1,3]
C0069515
Currently receiving treatment with any agents that are contraindicated by study therapies: A) IMC-A12 - none identified to date B) Lapatinib - CYPA34 inhibitors and inducers (see Appendix IV) including grapefruit and grapefruit juice (C Capecitabine - warfarinCoumadin, cimetidineTagamet, allopurinolLopurin, sorivudineUsevir, brivudineBrivex, ketoconazoleNizoral, itraconazoleSporanox, ritonavirNorvir, amprenavirAgenerase, or indinavirCrixivan)
Descrizione

PatientContraindicatedAgentExclusionCriteriaInd-2

Tipo di dati

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C1708
UMLS 2011AA Property
C0450442
NCI Thesaurus Property-2
C25370
UMLS 2011AA Property-2
C0680251
NCI Thesaurus Property-3
C37933
UMLS 2011AA Property-3
C1444657
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Uncontrolled intercurrent illness (including, but not limited to: - Poorly controlled diabetes - Ongoing or active infection - Symptomatic congestive heart failure - Unstable angina pectoris - Cardiac arrhythmia - Psychiatric illness/social situations that would limit compliance with study requirements)
Descrizione

PatientUncontrolledConcurrentDiseaseorDisorderExclusionCriteriaInd-2

Tipo di dati

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C2991
UMLS 2011AA Property
C0012634
NCI Thesaurus Property-2
C25456
UMLS 2011AA Property-2
C0205420
NCI Thesaurus Property-3
C48932
UMLS 2011AA Property-3
C0205318
NCI Thesaurus Property-4
C25370
UMLS 2011AA Property-4
C0680251
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of the safety (of the prescribed regimens.)
Descrizione

PatientConcurrentSystemicDiseaseorDisorderExclusionCriteriaInd-2

Tipo di dati

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C13310
UMLS 2011AA Property
C0205373
NCI Thesaurus Property-2
C2991
UMLS 2011AA Property-2
C0012634
NCI Thesaurus Property-3
C25456
UMLS 2011AA Property-3
C0205420
NCI Thesaurus Property-4
C25370
UMLS 2011AA Property-4
C0680251
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Currently receiving treatment in a different clinical study in which investigational procedures are performed or investigational therapies are administered
Descrizione

PatientInvestigationalClinicalTrialCurrentParticipationExclusionCriteriaInd-2

Tipo di dati

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25608
UMLS 2011AA Property
C0679823
NCI Thesaurus Property-2
C25471
UMLS 2011AA Property-2
C0521116
NCI Thesaurus Property-3
C15207
NCI Thesaurus Property-4
C28041
UMLS 2011AA Property-3
C1517586
NCI Thesaurus Property-5
C25370
UMLS 2011AA Property-4
C0680251
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Immunocompromised patients (other than that related to the use of corticosteroids) including patients known to be HIV positive with an AIDS-defining illness. (HIV positive patients with CD4 count within institutional normal range and no history of an AIDS-defining illness are eligible, however, some antiviral/antiretroviral medications which have CYP3A4 interactions are prohibited on this study.)
Descrizione

PatientImmunocompromisedExclusionCriteriaind-2

Tipo di dati

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25370
UMLS 2011AA Property
C0680251
NCI Thesaurus Property-2
C14139
UMLS 2011AA Property-2
C0085393
Registration Check
Descrizione

Registration Check

Consent form signed and dated
Descrizione

InformedConsentFormSignedInd-2

Tipo di dati

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16468
UMLS 2011AA ObjectClass
C0009797
NCI Thesaurus Property
C25679
Date Informed Consent Signed
Descrizione

InformedConsentFormSignedDate

Tipo di dati

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus ObjectClass
C16468
UMLS 2011AA ObjectClass
C0009797
NCI Thesaurus Property
C25679
Authorization for use and disclosure of protected health information signed and dated (Non-USA institution only check NA)
Descrizione

PatientHealthRecordIndicator

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25178
UMLS 2011AA Property
C0018684
Date of authorization
Descrizione

PatientSignedDischargeMedicalRecordDate

Tipo di dati

date

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25679
NCI Metathesaurus Property
C0012621
NCI Thesaurus Property-2
C45258
UMLS 2011AA Property
C0025102
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
A mandatory translational research component is part of this study, patients will automatically be registered to the translational research component of this study at the time of registration. (see Section 14.0 and 17.0)
Descrizione

PatientRegisteredInd-2

Tipo di dati

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25644
Treatment cannot begin prior to registration and must begin <=7 days after registration
Descrizione

ClinicalTrialTherapeuticProcedurePostRegistrationChecklistInd-2

Tipo di dati

boolean

Alias
NCI Thesaurus ObjectClass
C15207
NCI Thesaurus Property
C25646
UMLS 2011AA Property
C1514821
NCI Thesaurus Property-2
C38008
UMLS 2011AA Property-2
C0687676
NCI Thesaurus Property-3
C49236
UMLS 2011AA Property-3
C0087111
NCI Thesaurus Property-4
C49073
UMLS 2011AA Property-4
C1707357
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Pretreatment tests/procedures must be completed <= 7 days prior to registration (NOTE: The earliest pretreatment test/procedure date must be less than or equal to the earliest laboratory test/procedure date and the latest pretreatment test/procedure date must be greater than or equal to the latest laboratory test/procedure date.)
Descrizione

PatientPriorRegistrationLaboratoryProcedureVerificationInd-2

Tipo di dati

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25646
UMLS 2011AA Property
C1514821
NCI Thesaurus Property-2
C25629
UMLS 2011AA Property-2
C0332152
NCI Thesaurus Property-3
C25294
UMLS 2011AA Property-3
C0022885
NCI Thesaurus Property-4
C45513
UMLS 2011AA Property-4
C1711411
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Earliest pretreatment test/procedure date
Descrizione

PatientPriorRegistrationLaboratoryProcedureEligibilityDeterminationBeginDate

Tipo di dati

date

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25646
UMLS 2011AA Property
C1514821
NCI Thesaurus Property-2
C25629
UMLS 2011AA Property-2
C0332152
NCI Thesaurus Property-3
C25294
UMLS 2011AA Property-3
C0022885
NCI Thesaurus Property-4
C25171
UMLS 2011AA Property-4
C0013893
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25431
UMLS 2011AA ValueDomain-2
C0439659
Latest pretreatment test/procedure date
Descrizione

PatientPriorRegistrationLaboratoryProcedureEligibilityDeterminationEndDate

Tipo di dati

date

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25646
UMLS 2011AA Property
C1514821
NCI Thesaurus Property-2
C25629
UMLS 2011AA Property-2
C0332152
NCI Thesaurus Property-3
C25294
UMLS 2011AA Property-3
C0022885
NCI Thesaurus Property-4
C25171
UMLS 2011AA Property-4
C0013893
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Earliest exception test date (Tumor measurement, Chest x-ray or CT, Bone scan, Brain MRI or CT, must be done <=21 days prior to registration see Section 4.0.)
Descrizione

PatientPriorRegistrationDiagnosticImagingEligibilityDeterminationBeginDate

Tipo di dati

date

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C16502
UMLS 2011AA Property
C0011923
NCI Thesaurus Property-2
C25646
UMLS 2011AA Property-2
C1514821
NCI Thesaurus Property-3
C25629
UMLS 2011AA Property-3
C0332152
NCI Thesaurus Property-4
C25171
UMLS 2011AA Property-4
C0013893
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25431
UMLS 2011AA ValueDomain-2
C0439659
latest exception test date
Descrizione

PatientPriorRegistrationDiagnosticImagingEligibilityDeterminationEndDate

Tipo di dati

date

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C16502
UMLS 2011AA Property
C0011923
NCI Thesaurus Property-2
C25646
UMLS 2011AA Property-2
C1514821
NCI Thesaurus Property-3
C25629
UMLS 2011AA Property-3
C0332152
NCI Thesaurus Property-4
C25171
UMLS 2011AA Property-4
C0013893
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Date of EKG (Electrocardiogram EKG must be done <=28 days prior to registration see Section 4.0.)
Descrizione

DiagnosticElectrocardiogramPerformedDate

Tipo di dati

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus ObjectClass
C25482
UMLS 2011AA ObjectClass
C0348026
NCI Metathesaurus ObjectClass
C0013798
All required baseline symptoms (see Section 10.3) must be documented and graded
Descrizione

ClinicalTrialBaselineDiseaseDocumentedChecklistInd-2

Tipo di dati

boolean

Alias
NCI Thesaurus ObjectClass
C15207
NCI Thesaurus Property
C25213
UMLS 2011AA Property
C1442488
NCI Thesaurus Property-2
C2991
UMLS 2011AA Property-2
C0012634
NCI Thesaurus Property-3
C25356
UMLS 2011AA Property-3
C1301725
NCI Thesaurus Property-4
C49073
UMLS 2011AA Property-4
C1707357
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Study drug availability checked (Study drug must be in site pharmacy for this patient prior to registration)
Descrizione

ClinicalTrialProtocolAgentAvailabilityChecklistInd-2

Tipo di dati

boolean

Alias
NCI Thesaurus ObjectClass
C15207
NCI Thesaurus Property
C41161
UMLS 2011AA Property
C1521826
NCI Thesaurus Property-2
C25429
UMLS 2011AA Property-2
C0470187
NCI Thesaurus Property-3
C49073
UMLS 2011AA Property-3
C1707357
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Blood draw kit availability checked (Site must have a kit on hand for this patient prior to registration)
Descrizione

ClinicalTrialBloodSpecimenCollectionAvailabilityChecklistInd-2

Tipo di dati

boolean

Alias
NCI Thesaurus ObjectClass
C15207
NCI Thesaurus Property
C12434
UMLS 2011AA Property
C0229664
NCI Thesaurus Property-2
C25453
UMLS 2011AA Property-2
C1516698
NCI Thesaurus Property-3
C19157
UMLS 2011AA Property-3
C0370003
NCI Thesaurus Property-4
C25429
UMLS 2011AA Property-4
C0470187
NCI Thesaurus Property-5
C49073
UMLS 2011AA Property-5
C1707357
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
This protocol has a mandatory quality assurance (QA) audit submission of diagnostic slides and HER2 stained slides used to make a HER2 positive metastatic breast cancer diagnosis, plus corresponding operating and pathology reports (If these materials are not available, the patient is not eligible for this trial)
Descrizione

ClinicalTrialQualityAssuranceERBB2ReceptorProtein-TyrosineKinaseDiagnosisChecklistInd-2

Tipo di dati

boolean

Alias
NCI Thesaurus ObjectClass
C15207
NCI Thesaurus Property
C15220
UMLS 2011AA Property
C0011900
NCI Thesaurus Property-2
C49073
UMLS 2011AA Property-2
C1707357
NCI Thesaurus Property-3
C17319
UMLS 2011AA Property-3
C0069515
NCI Thesaurus Property-4
C15381
UMLS 2011AA Property-4
C0178932
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Patient QOL booklet availability checked; copies are not acceptable for this submission (Site must have booklets on hand for this patient prior to registration)
Descrizione

ClinicalTrialQualityofLifeAvailabilityChecklistInd-2

Tipo di dati

boolean

Alias
NCI Thesaurus ObjectClass
C15207
NCI Thesaurus Property
C17047
UMLS 2011AA Property
C0518214
NCI Thesaurus Property-2
C25429
UMLS 2011AA Property-2
C0470187
NCI Thesaurus Property-3
C49073
UMLS 2011AA Property-3
C1707357
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
This protocol has mandatory monitoring for the Safety Cohort - sites must participate in monthly conference calls (see Section 16.8.4)
Descrizione

ClinicalTrialStudyMonitorChecklistInd-2

Tipo di dati

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C15207
NCI Thesaurus Property
C49073
UMLS 2011AA Property
C1707357
NCI Thesaurus Property-2
C41201
UMLS 2011AA Property-2
C1521743
At The Time Of Registration/randomization, The Following Will Also Be Recorded:
Descrizione

At The Time Of Registration/randomization, The Following Will Also Be Recorded:

Patient has given permission to keep sample(s) for use in future research to learn about, prevent, or treat cancer
Descrizione

PersonSpecimenMalignantNeoplasmResearchConsentInd-2

Tipo di dati

boolean

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C15319
NCI Thesaurus Property-2
C9305
UMLS 2011AA Property
C0006826
NCI Thesaurus Property-3
C19157
UMLS 2011AA Property-2
C0370003
NCI Thesaurus Property-4
C25460
UMLS 2011AA Property-3
C1511481
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Patient has given permission to keep sample(s) for use in future research to learn about, prevent, or treat other health problems (for example: diabetes, Alzheimer's disease, or heart disease)
Descrizione

BloodTissueSpecimenOtherDiseasesandDisordersResearchConsentInd-3

Tipo di dati

boolean

Alias
NCI Thesaurus ObjectClass
C12801
UMLS 2011AA ObjectClass
C0040300
NCI Thesaurus ObjectClass-2
C12434
UMLS 2011AA ObjectClass-2
C0229664
NCI Thesaurus ObjectClass-3
C19157
UMLS 2011AA ObjectClass-3
C0370003
NCI Thesaurus Property
C17649
UMLS 2011AA Property
C0205394
NCI Thesaurus Property-2
C15319
NCI Thesaurus Property-3
C2991
UMLS 2011AA Property-2
C0012634
NCI Thesaurus Property-4
C25460
UMLS 2011AA Property-3
C1511481
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Patient has given NCCTG permission to give sample(s) to outside researchers
Descrizione

PersonSpecimenExternalInvestigatorConsentInd-2

Tipo di dati

boolean

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C44280
UMLS 2011AA Property
C0205101
NCI Thesaurus Property-2
C19157
UMLS 2011AA Property-2
C0370003
NCI Thesaurus Property-3
C25936
UMLS 2011AA Property-3
C0035173
NCI Thesaurus Property-4
C25460
UMLS 2011AA Property-4
C1511481
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Stratification Factors
Descrizione

Stratification Factors

Receptor Status (Hormone)
Descrizione

BreastHormoneReceptorTumorMarkerFinalDiagnosisResultType

Tipo di dati

text

Alias
NCI Thesaurus ObjectClass
C12971
UMLS 2011AA ObjectClass
C0006141
NCI Thesaurus ObjectClass-2
C17220
UMLS 2011AA ObjectClass-2
C0041365
NCI Thesaurus ObjectClass-3
C28154
UMLS 2011AA ObjectClass-3
C0019929
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C15220
UMLS 2011AA Property-2
C0011900
NCI Thesaurus Property-3
C25508
UMLS 2011AA Property-3
C0205088
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Number of prior chemotherapy regimens in the metastatic setting
Descrizione

PriorChemotherapyMetastaticRegimenChemotherapyRegimenCount

Tipo di dati

text

Alias
NCI Thesaurus ObjectClass
C15632
UMLS 2011AA ObjectClass
C0392920
NCI Thesaurus ObjectClass-2
C25629
UMLS 2011AA ObjectClass-2
C0332152
NCI Thesaurus Property
C14174
UMLS 2011AA Property
C0036525
NCI Thesaurus Property-2
C15697
UMLS 2011AA Property-2
C0040808
NCI Thesaurus ValueDomain
C25463
UMLS 2011AA ValueDomain
C0750480
Subgroup Code
Descrizione

PatientSubgroupCharacteristicsStratificationDescriptionType

Tipo di dati

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ObjectClass-2
C25693
UMLS 2011AA ObjectClass-2
C1515021
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
NCI Thesaurus Property-2
C25689
UMLS 2011AA Property-2
C1514983
NCI Thesaurus Property-3
C25447
UMLS 2011AA Property-3
C1521970
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
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Similar models

First 10 patients only: Prior to discussing this protocol with the patient call the CTSU office 1-888-462-3009 to see if there is a place available for your patient.

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
Header
PatientNorthCentralCancerTreatmentGroupIdentifierNumber
Item
NCCTG Patient ID (provided at time of Reg/Random)
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25581 (NCI Thesaurus Property-2)
C1518419 (UMLS 2011AA Property-2)
Medical Record Number
Item
Patient Hospital No.
text
C25337 (NCI Thesaurus ValueDomain)
C1301894 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25261 (NCI Thesaurus Property)
C25198 (NCI Thesaurus Property-2)
ParticipatingGroupIdentifierCode
Item
Participating Group Code (Cooperative Group where credit will be applied)
text
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C25608 (NCI Thesaurus ObjectClass)
C0679823 (UMLS 2011AA ObjectClass)
C17005 (NCI Thesaurus ObjectClass-2)
C1257890 (UMLS 2011AA ObjectClass-2)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
Institution Name
Item
Institution Name (treating location/performance site)
text
C25191 (NCI Thesaurus ValueDomain)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass)
C21541 (NCI Thesaurus ValueDomain-2)
C25364 (NCI Thesaurus Property)
NationalCancerInstituteInstituteCode
Item
Institution Code (CTEP assigned number)
text
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C21541 (NCI Thesaurus ObjectClass)
C0018704 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
PhysicianPerformingImagingSeriesName
Item
Physician of Record
text
C25674 (NCI Thesaurus ObjectClass)
C0205549 (UMLS 2011AA ObjectClass)
C18843 (NCI Thesaurus ObjectClass-2)
C1704382 (UMLS 2011AA ObjectClass-2)
C25741 (NCI Thesaurus Property)
C0031831 (UMLS 2011AA Property)
C38000 (NCI Thesaurus Property-2)
C0884358 (UMLS 2011AA Property-2)
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
IRB Approval Date
Item
IRB/REB Approval Date (mm/dd/yyyy)
date
C25320 (NCI Thesaurus ObjectClass)
C2346500 (UMLS CUI-1)
C16741 (NCI Thesaurus Property)
C25425 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
PatientRegistrationDate
Item
Date of Registration (mm/dd/yyyy)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25367 (NCI Thesaurus ValueDomain-2)
C25646 (NCI Thesaurus Property)
C1514821 (UMLS 2011AA Property)
Person Completing Form Last Name
Item
Last name
text
C25190 (NCI Thesaurus ObjectClass)
C1550483 (UMLS CUI-1)
C25657 (NCI Thesaurus ObjectClass-2)
C1301584 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25551 (NCI Thesaurus Property-2)
C25191 (NCI Thesaurus ValueDomain)
Person Completing Form First Name
Item
First Name
text
C25190 (NCI Thesaurus ObjectClass)
C1550483 (UMLS CUI-1)
C25657 (NCI Thesaurus ObjectClass-2)
C1443235 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25509 (NCI Thesaurus Property-2)
C25191 (NCI Thesaurus ValueDomain)
Person Completing Form Phone
Item
Phone
text
C25337 (NCI Thesaurus ValueDomain)
C1550483 (UMLS CUI-1)
C25190 (NCI Thesaurus ObjectClass)
C1515258 (UMLS CUI-2)
C25657 (NCI Thesaurus ObjectClass-2)
C25395 (NCI Thesaurus Property)
ResponsiblePersonFaxNumber
Item
Fax
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25657 (NCI Thesaurus ObjectClass-2)
C1273518 (UMLS 2011AA ObjectClass-2)
C25210 (NCI Thesaurus Property)
C0085205 (UMLS 2011AA Property)
ResponsiblePersonE-mailAddressText
Item
E-mail
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25657 (NCI Thesaurus ObjectClass)
C1273518 (UMLS 2011AA ObjectClass)
C42775 (NCI Thesaurus Property)
C1705961 (UMLS 2011AA Property)
Item Group
Patient Demographics / Pre-treatment Characteristics
Patient Initials Last
Item
Last
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1517741 (UMLS CUI-2)
C25536 (NCI Thesaurus Property)
C25551 (NCI Thesaurus Property-2)
Patient Initials First
Item
First
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C0205435 (UMLS CUI-2)
C25536 (NCI Thesaurus Property)
C25509 (NCI Thesaurus Property-2)
PatientMiddleInitialsName
Item
Middle
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25536 (NCI Thesaurus Property)
C1555582 (UMLS 2011AA Property)
C25569 (NCI Thesaurus Property-2)
C0444598 (UMLS 2011AA Property-2)
Item
Gender
text
C25372 (NCI Thesaurus ValueDomain)
C0079399 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C17357 (NCI Thesaurus Property)
CL.1
Code List
Gender
CL Item
Male (MALE)
C46109 (NCI Thesaurus)
C1706180 (UMLS 2011AA)
CL Item
Female (FEMALE)
C46110 (NCI Thesaurus)
C0015780 (UMLS 2011AA)
CL Item
Unknown (UNKNOWN)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
Ethnicity (U.S. and Canada only)
text
C25372 (NCI Thesaurus ValueDomain)
C0015031 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C16564 (NCI Thesaurus Property)
CL.2
Code List
Ethnicity (U.S. and Canada only)
CL Item
A Person Of Mexican, Puerto Rican, Cuban, Central Or South American Or Other Spanish Culture Or Origin, Regardless Of Race. (HISPANIC OR LATINO)
C17459 (NCI Thesaurus)
C0086409 (UMLS 2011AA)
CL Item
A Person Not Meeting The Definition For Hispanic Or Latino. (NOT HISPANIC OR LATINO)
C41222 (NCI Thesaurus)
C1518424 (UMLS 2011AA)
CL Item
Not Provided Or Available (Not reported)
C43234 (NCI Thesaurus)
C1706613 (UMLS 2011AA)
CL Item
Could Not Be Determined Or Unsure (UNKNOWN)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Patient Birth Date
Item
Patient's Date of Birth (mm/dd/yyyy)
date
C25164 (NCI Thesaurus ValueDomain)
C0421451 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain-2)
C25155 (NCI Thesaurus Property)
PatientAddressPostalCode
Item
Patient Zip Code
text
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25407 (NCI Thesaurus Property)
C1442065 (UMLS 2011AA Property)
Item
Country of residence
text
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25407 (NCI Thesaurus Property)
C1442065 (UMLS 2011AA Property)
CL.3
Code List
Country of residence
CL Item
Ascension Island (AC)
CL Item
Andorra (AD)
C16289 (NCI Thesaurus)
C0002838 (UMLS 2011AA)
CL Item
United Arab Emirates (AE)
C17232 (NCI Thesaurus)
C0041698 (UMLS 2011AA)
CL Item
Afghanistan (AF)
C16267 (NCI Thesaurus)
C0001732 (UMLS 2011AA)
CL Item
Antigua And Barbuda (AG)
C16303 (NCI Thesaurus)
C0003354 (UMLS 2011AA)
CL Item
Anguilla (AI)
C20133 (NCI Thesaurus)
C0003353 (UMLS 2011AA)
CL Item
Albania (AL)
CL Item
Armenia (AM)
C16306 (NCI Thesaurus)
C0003798 (UMLS 2011AA)
CL Item
Netherland Antilles (AN)
CL Item
Angola (AO)
C16292 (NCI Thesaurus)
C0003023 (UMLS 2011AA)
CL Item
Antarctica (AQ)
C18007 (NCI Thesaurus)
C0454691 (UMLS 2011AA)
CL Item
Argentina (AR)
C16305 (NCI Thesaurus)
C0003761 (UMLS 2011AA)
CL Item
American Samoa (AS)
C17739 (NCI Thesaurus)
C0242536 (UMLS 2011AA)
CL Item
Austria (AT)
C16312 (NCI Thesaurus)
C0004348 (UMLS 2011AA)
CL Item
Australia (AU)
C16311 (NCI Thesaurus)
C0004340 (UMLS 2011AA)
CL Item
Aruba (AW)
C17884 (NCI Thesaurus)
C0282379 (UMLS 2011AA)
CL Item
Azerbaidjan (AZ)
CL Item
Bosnia-herzegovina (BA)
C16361 (NCI Thesaurus)
C0006036 (UMLS 2011AA)
CL Item
Barbados (BB)
C16324 (NCI Thesaurus)
C0004739 (UMLS 2011AA)
CL Item
Bangladesh (BD)
C16323 (NCI Thesaurus)
C0004732 (UMLS 2011AA)
CL Item
Belgium (BE)
C16329 (NCI Thesaurus)
C0004950 (UMLS 2011AA)
CL Item
Burkina Faso (BF)
C16369 (NCI Thesaurus)
C0006409 (UMLS 2011AA)
CL Item
Bulgaria (BG)
C16368 (NCI Thesaurus)
C0006368 (UMLS 2011AA)
CL Item
Bahrain (BH)
C16322 (NCI Thesaurus)
C0004684 (UMLS 2011AA)
CL Item
Burundi (BI)
C16371 (NCI Thesaurus)
C0006448 (UMLS 2011AA)
CL Item
Benin (BJ)
CL Item
Bermuda (BM)
C16334 (NCI Thesaurus)
C0005126 (UMLS 2011AA)
CL Item
Brunei Darussalam (BN)
C16367 (NCI Thesaurus)
C0006320 (UMLS 2011AA)
CL Item
Bolivia (BO)
C16359 (NCI Thesaurus)
C0005918 (UMLS 2011AA)
CL Item
Brazil (BR)
C16364 (NCI Thesaurus)
C0006137 (UMLS 2011AA)
CL Item
Bahamas (BS)
C16321 (NCI Thesaurus)
C0004683 (UMLS 2011AA)
CL Item
Bhutan (BT)
C16336 (NCI Thesaurus)
C0005341 (UMLS 2011AA)
CL Item
Bouvet Island (BV)
C20104 (NCI Thesaurus)
C1511278 (UMLS 2011AA)
CL Item
Botswana (BW)
C16363 (NCI Thesaurus)
C0006041 (UMLS 2011AA)
CL Item
Belarus (BY)
C16372 (NCI Thesaurus)
C0006539 (UMLS 2011AA)
CL Item
Belize (BZ)
C16331 (NCI Thesaurus)
C0004952 (UMLS 2011AA)
CL Item
Canada (CA)
C16380 (NCI Thesaurus)
C0006823 (UMLS 2011AA)
CL Item
Cocos Isl. (CC)
CL Item
Rep. Dem. Congo (CD)
CL Item
Central African Rep. (CF)
CL Item
Congo (CG)
C16467 (NCI Thesaurus)
C0009738 (UMLS 2011AA)
CL Item
Switzerland (CH)
C17181 (NCI Thesaurus)
C0039021 (UMLS 2011AA)
CL Item
Ivory Coast (CI)
CL Item
Cook Islands (CK)
C16469 (NCI Thesaurus)
C0009956 (UMLS 2011AA)
CL Item
Chile (CL)
CL Item
Cameroon (CM)
C16379 (NCI Thesaurus)
C0006802 (UMLS 2011AA)
CL Item
China (CN)
C16428 (NCI Thesaurus)
C0008115 (UMLS 2011AA)
CL Item
Colombia (CO)
C16449 (NCI Thesaurus)
C0009367 (UMLS 2011AA)
CL Item
Costa Rica (CR)
C16470 (NCI Thesaurus)
C0010182 (UMLS 2011AA)
CL Item
Cuba (CU)
C16477 (NCI Thesaurus)
C0010435 (UMLS 2011AA)
CL Item
Cape Verde (CV)
C16382 (NCI Thesaurus)
C0006893 (UMLS 2011AA)
CL Item
Christmas Island (CX)
C44482 (NCI Thesaurus)
C0006888 (UMLS 2011AA)
CL Item
Cyprus (CY)
C16480 (NCI Thesaurus)
C0010622 (UMLS 2011AA)
CL Item
Czech Republic (CZ)
C17668 (NCI Thesaurus)
C0206578 (UMLS 2011AA)
CL Item
Germany (DE)
CL Item
Djibouti (DJ)
CL Item
Denmark (DK)
CL Item
Dominica (DM)
CL Item
Dominican Republic (DO)
CL Item
Algeria (DZ)
CL Item
Ecuador (EC)
CL Item
Estonia (EE)
CL Item
Egypt (EG)
CL Item
Western Sahara (EH)
CL Item
Eritrea (ER)
CL Item
Spain (ES)
CL Item
Ethiopia (ET)
CL Item
Finland (FI)
CL Item
Fiji (FJ)
CL Item
Falkland Isl. (FK)
CL Item
Micronesia (FM)
CL Item
Faroe Islands (FO)
CL Item
France (FR)
CL Item
France (european Ter.) (FX)
CL Item
Gabon (GA)
CL Item
Great Britain (GB)
CL Item
Grenada (GD)
CL Item
Georgia (GE)
CL Item
Guiana (fr.) (GF)
CL Item
Guernsey (GG)
CL Item
Ghana (GH)
CL Item
Gibraltar (GI)
CL Item
Greenland (GL)
CL Item
Gambia (GM)
CL Item
Guinea (GN)
CL Item
Guadeloupe (fr.) (GP)
CL Item
Equatorial Guinea (GQ)
CL Item
Greece (GR)
CL Item
South Georgia And South Sandwich Islands (GS)
CL Item
Guatemala (GT)
CL Item
Guam (us) (GU)
CL Item
Guinea Bissau (GW)
CL Item
Guyana (GY)
CL Item
Hong Kong (HK)
CL Item
Heard & Mcdonald Isl. (HM)
CL Item
Honduras (HN)
C16694 (NCI Thesaurus)
C0019905 (UMLS 2011AA)
CL Item
Croatia (HR)
C16474 (NCI Thesaurus)
C0010343 (UMLS 2011AA)
CL Item
Haiti (HT)
C16660 (NCI Thesaurus)
C0018510 (UMLS 2011AA)
CL Item
Hungary (HU)
C16699 (NCI Thesaurus)
C0020174 (UMLS 2011AA)
CL Item
Indonesia (ID)
C16728 (NCI Thesaurus)
C0021247 (UMLS 2011AA)
CL Item
Ireland (IE)
C16757 (NCI Thesaurus)
C0022067 (UMLS 2011AA)
CL Item
Israel (IL)
C16760 (NCI Thesaurus)
C0022271 (UMLS 2011AA)
CL Item
Isle Of Man (IM)
C0022132 (NCI Metathesaurus)
CL Item
India (IN)
C16727 (NCI Thesaurus)
C0021201 (UMLS 2011AA)
CL Item
British Indian O. Ter. (IO)
CL Item
Iraq (IQ)
C16756 (NCI Thesaurus)
C0022066 (UMLS 2011AA)
CL Item
Iran (IR)
C16755 (NCI Thesaurus)
C0022065 (UMLS 2011AA)
CL Item
Iceland (IS)
C16704 (NCI Thesaurus)
C0020750 (UMLS 2011AA)
CL Item
Italy (IT)
C16761 (NCI Thesaurus)
C0022277 (UMLS 2011AA)
CL Item
Jersey (JE)
CL Item
Jamaica (JM)
C16763 (NCI Thesaurus)
C0022337 (UMLS 2011AA)
CL Item
Jordan (JO)
C16765 (NCI Thesaurus)
C0022418 (UMLS 2011AA)
CL Item
Japan (JP)
C16764 (NCI Thesaurus)
C0022341 (UMLS 2011AA)
CL Item
Kenya (KE)
C16769 (NCI Thesaurus)
C0022558 (UMLS 2011AA)
CL Item
Kyrgyz Republic (KG)
CL Item
Cambodia (KH)
C16378 (NCI Thesaurus)
C0006797 (UMLS 2011AA)
CL Item
Kiribati (KI)
C16639 (NCI Thesaurus)
C0017550 (UMLS 2011AA)
CL Item
Comoros (KM)
C16458 (NCI Thesaurus)
C0009490 (UMLS 2011AA)
CL Item
St. Kitts Nevis Anguilla (KN)
CL Item
Korea (north) (KP)
CL Item
Korea (south) (KR)
CL Item
Kuwait (KW)
C16775 (NCI Thesaurus)
C0022804 (UMLS 2011AA)
CL Item
Cayman Islands (KY)
C16391 (NCI Thesaurus)
C0007481 (UMLS 2011AA)
CL Item
Kazakstan (KZ)
CL Item
Laos (LA)
CL Item
Lebanon (LB)
C16784 (NCI Thesaurus)
C0023190 (UMLS 2011AA)
CL Item
Saint Lucia (LC)
C17113 (NCI Thesaurus)
C0036056 (UMLS 2011AA)
CL Item
Liechtenstein (LI)
C16794 (NCI Thesaurus)
C0023668 (UMLS 2011AA)
CL Item
Sri Lanka (LK)
C17163 (NCI Thesaurus)
C0038088 (UMLS 2011AA)
CL Item
Liberia (LR)
C16791 (NCI Thesaurus)
C0023617 (UMLS 2011AA)
CL Item
Lesotho (LS)
CL Item
Lithuania (LT)
C16799 (NCI Thesaurus)
C0023879 (UMLS 2011AA)
CL Item
Luxembourg (LU)
C16803 (NCI Thesaurus)
C0024176 (UMLS 2011AA)
CL Item
Latvia (LV)
C16783 (NCI Thesaurus)
C0023128 (UMLS 2011AA)
CL Item
Libya (LY)
CL Item
Morocco (MA)
C16878 (NCI Thesaurus)
C0026544 (UMLS 2011AA)
CL Item
Monaco (MC)
C16874 (NCI Thesaurus)
C0026405 (UMLS 2011AA)
CL Item
Moldova (MD)
C16871 (NCI Thesaurus)
C0026374 (UMLS 2011AA)
CL Item
Madagascar (MG)
C16808 (NCI Thesaurus)
C0024443 (UMLS 2011AA)
CL Item
Marshall Islands (MH)
C16822 (NCI Thesaurus)
C0024851 (UMLS 2011AA)
CL Item
Macedonia (MK)
C0700290 (NCI Metathesaurus)
CL Item
Mali (ML)
C16816 (NCI Thesaurus)
C0024581 (UMLS 2011AA)
CL Item
Myanmar (MM)
C16370 (NCI Thesaurus)
C0006416 (UMLS 2011AA)
CL Item
Mongolia (MN)
C16875 (NCI Thesaurus)
C0026410 (UMLS 2011AA)
CL Item
Macau (MO)
C16807 (NCI Thesaurus)
C0024403 (UMLS 2011AA)
CL Item
Northern Mariana Isl. (MP)
CL Item
Martinique (fr.) (MQ)
CL Item
Mauritania (MR)
C16826 (NCI Thesaurus)
C0024943 (UMLS 2011AA)
CL Item
Montserrat (MS)
C16876 (NCI Thesaurus)
C0026514 (UMLS 2011AA)
CL Item
Malta (MT)
C16817 (NCI Thesaurus)
C0024653 (UMLS 2011AA)
CL Item
Mauritius (MU)
C16827 (NCI Thesaurus)
C0024944 (UMLS 2011AA)
CL Item
Maldives (MV)
C16815 (NCI Thesaurus)
C0024553 (UMLS 2011AA)
CL Item
Malawi (MW)
C16813 (NCI Thesaurus)
C0024548 (UMLS 2011AA)
CL Item
Mexico (MX)
C16850 (NCI Thesaurus)
C0025885 (UMLS 2011AA)
CL Item
Malaysia (MY)
C16814 (NCI Thesaurus)
C0024552 (UMLS 2011AA)
CL Item
Mozambique (MZ)
C16882 (NCI Thesaurus)
C0026655 (UMLS 2011AA)
CL Item
Namibia (NA)
C16891 (NCI Thesaurus)
C0027366 (UMLS 2011AA)
CL Item
New Caledonia (fr.) (NC)
CL Item
Niger (NE)
C16916 (NCI Thesaurus)
C0028074 (UMLS 2011AA)
CL Item
Norfolk Island (NF)
C16919 (NCI Thesaurus)
C0028366 (UMLS 2011AA)
CL Item
Nigeria (NG)
C16917 (NCI Thesaurus)
C0028075 (UMLS 2011AA)
CL Item
Nicaragua (NI)
C16915 (NCI Thesaurus)
C0028002 (UMLS 2011AA)
CL Item
Netherlands (NL)
C16903 (NCI Thesaurus)
C0027778 (UMLS 2011AA)
CL Item
Norway (NO)
C16920 (NCI Thesaurus)
C0028423 (UMLS 2011AA)
CL Item
Nepal (NP)
C16901 (NCI Thesaurus)
C0027689 (UMLS 2011AA)
CL Item
Nauru (NR)
C16896 (NCI Thesaurus)
C0027496 (UMLS 2011AA)
CL Item
Niue (NU)
C16918 (NCI Thesaurus)
C0028219 (UMLS 2011AA)
CL Item
New Zealand (NZ)
C16914 (NCI Thesaurus)
C0027978 (UMLS 2011AA)
CL Item
Oman (OM)
C16933 (NCI Thesaurus)
C0028971 (UMLS 2011AA)
CL Item
Other (Other)
CL Item
Panama (PA)
C16951 (NCI Thesaurus)
C0030266 (UMLS 2011AA)
CL Item
Peru (PE)
C16972 (NCI Thesaurus)
C0031238 (UMLS 2011AA)
CL Item
Polynesia (fr.) (PF)
CL Item
Papua New Guinea (PG)
C16952 (NCI Thesaurus)
C0030375 (UMLS 2011AA)
CL Item
Philippines (PH)
CL Item
Pakistan (PK)
C16949 (NCI Thesaurus)
C0030211 (UMLS 2011AA)
CL Item
Poland (PL)
C17002 (NCI Thesaurus)
C0032356 (UMLS 2011AA)
CL Item
St. Pierre & Miquelon (PM)
CL Item
Pitcairn (PN)
C16993 (NCI Thesaurus)
C0031995 (UMLS 2011AA)
CL Item
Puerto Rico (PR)
C17043 (NCI Thesaurus)
C0034044 (UMLS 2011AA)
CL Item
Portugal (PT)
C17006 (NCI Thesaurus)
C0032729 (UMLS 2011AA)
CL Item
Palau (PW)
C17733 (NCI Thesaurus)
C0242397 (UMLS 2011AA)
CL Item
Paraguay (PY)
C16953 (NCI Thesaurus)
C0030428 (UMLS 2011AA)
CL Item
Qatar (QA)
C17045 (NCI Thesaurus)
C0034366 (UMLS 2011AA)
CL Item
Reunion (fr.) (RE)
CL Item
Romania (RO)
C17108 (NCI Thesaurus)
C0035826 (UMLS 2011AA)
CL Item
Russian Federation (RU)
CL Item
Rwanda (RW)
C17112 (NCI Thesaurus)
C0035978 (UMLS 2011AA)
CL Item
Saudi Arabia (SA)
C17117 (NCI Thesaurus)
C0036243 (UMLS 2011AA)
CL Item
Solomon Islands (SB)
C17148 (NCI Thesaurus)
C0037623 (UMLS 2011AA)
CL Item
Seychelles (SC)
C17129 (NCI Thesaurus)
C0036919 (UMLS 2011AA)
CL Item
Sudan (SD)
C17170 (NCI Thesaurus)
C0038642 (UMLS 2011AA)
CL Item
Sweden (SE)
C17180 (NCI Thesaurus)
C0038995 (UMLS 2011AA)
CL Item
Singapore (SG)
C17134 (NCI Thesaurus)
C0037173 (UMLS 2011AA)
CL Item
St. Helena (SH)
CL Item
Slovenia (SI)
C17138 (NCI Thesaurus)
C0037334 (UMLS 2011AA)
CL Item
Svalbard & Jan Mayen Isl. (SJ)
CL Item
Slovakia (SK)
C17669 (NCI Thesaurus)
C0206579 (UMLS 2011AA)
CL Item
Sierra Leone (SL)
C17130 (NCI Thesaurus)
C0037063 (UMLS 2011AA)
CL Item
San Marino (SM)
C17115 (NCI Thesaurus)
C0036154 (UMLS 2011AA)
CL Item
Senegal (SN)
C17121 (NCI Thesaurus)
C0036644 (UMLS 2011AA)
CL Item
Somalia (SO)
C17149 (NCI Thesaurus)
C0037640 (UMLS 2011AA)
CL Item
Suriname (SR)
C17175 (NCI Thesaurus)
C0038944 (UMLS 2011AA)
CL Item
St. Tome And Principe (ST)
CL Item
Soviet Union (SU)
CL Item
El Salvador (SV)
C16532 (NCI Thesaurus)
C0013754 (UMLS 2011AA)
CL Item
Syria (SY)
C17182 (NCI Thesaurus)
C0039138 (UMLS 2011AA)
CL Item
Swaziland (SZ)
C17179 (NCI Thesaurus)
C0038983 (UMLS 2011AA)
CL Item
Turks & Caicos Islands (TC)
CL Item
Chad (TD)
C16412 (NCI Thesaurus)
C0007928 (UMLS 2011AA)
CL Item
French Southern Terr. (TF)
CL Item
Togo (TG)
C17202 (NCI Thesaurus)
C0040363 (UMLS 2011AA)
CL Item
Thailand (TH)
C17192 (NCI Thesaurus)
C0039725 (UMLS 2011AA)
CL Item
Tadjikistan (TJ)
CL Item
Tokelau (TK)
C17704 (NCI Thesaurus)
C0220928 (UMLS 2011AA)
CL Item
Turkmenistan (TM)
C17223 (NCI Thesaurus)
C0041403 (UMLS 2011AA)
CL Item
Tunisia (TN)
C17221 (NCI Thesaurus)
C0041388 (UMLS 2011AA)
CL Item
Tonga (TO)
CL Item
East Timor (TP)
C17200 (NCI Thesaurus)
C1452561 (UMLS 2011AA)
CL Item
Turkey (TR)
C17222 (NCI Thesaurus)
C0041400 (UMLS 2011AA)
CL Item
Trinidad & Tobago (TT)
CL Item
Tuvalu (TV)
C17225 (NCI Thesaurus)
C0041413 (UMLS 2011AA)
CL Item
Taiwan (TW)
C17184 (NCI Thesaurus)
C0039260 (UMLS 2011AA)
CL Item
Tanzania (TZ)
C17185 (NCI Thesaurus)
C0039298 (UMLS 2011AA)
CL Item
Ukraine (UA)
C17229 (NCI Thesaurus)
C0041580 (UMLS 2011AA)
CL Item
Uganda (UG)
C17228 (NCI Thesaurus)
C0041573 (UMLS 2011AA)
CL Item
United Kingdom (UK)
C17233 (NCI Thesaurus)
C0041700 (UMLS 2011AA)
CL Item
Us Minor Outlying Isl. (UM)
CL Item
Usa (US)
CL Item
Uruguay (UY)
C17244 (NCI Thesaurus)
C0042113 (UMLS 2011AA)
CL Item
Uzbekistan (UZ)
C17246 (NCI Thesaurus)
C0042177 (UMLS 2011AA)
CL Item
Vatican City State (VA)
CL Item
St. Vincent & Grenadines (VC)
CL Item
Venezuela (VE)
C17250 (NCI Thesaurus)
C0042469 (UMLS 2011AA)
CL Item
Virgin Islands (brit) (VG)
CL Item
Virgin Islands (us) (VI)
CL Item
Vietnam (VN)
C17252 (NCI Thesaurus)
C0042658 (UMLS 2011AA)
CL Item
Vanuatu (VU)
C17247 (NCI Thesaurus)
C0042321 (UMLS 2011AA)
CL Item
Wallis & Futuna Islands (WF)
CL Item
Western Samoa (WS)
CL Item
Yemen (YE)
C17264 (NCI Thesaurus)
C0043402 (UMLS 2011AA)
CL Item
Mayotte (YT)
C16828 (NCI Thesaurus)
C0024974 (UMLS 2011AA)
CL Item
Yugoslavia (YU)
CL Item
South Africa (ZA)
CL Item
Zambia (ZM)
C17267 (NCI Thesaurus)
C0043445 (UMLS 2011AA)
CL Item
Dem. Rep. Of Congo (ZR)
CL Item
Zimbabwe (ZW)
C17268 (NCI Thesaurus)
C0043476 (UMLS 2011AA)
Item
Method of Payment (check oneUSA only)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25371 (NCI Thesaurus Property)
C0680264 (UMLS 2011AA Property)
CL.4
Code List
Method of Payment (check oneUSA only)
CL Item
Private Insurance (Private Insurance)
CL Item
Medicare (Medicare)
C16665 (NCI Thesaurus)
C0018717 (UMLS 2011AA)
CL Item
Medicaid (Medicaid)
C0025071 (NCI Metathesaurus)
CL Item
Medicaid And Medicare (Medicaid and Medicare)
CL Item
Medicare And Private Insurance (Medicare and Private Insurance)
CL Item
Military Or Veterans Sponsored Nos (Military or Veterans Sponsored, Not Otherwise Specified (NOS))
CL Item
Military Sponsored (including Champus & Tricare) (Military Sponsored (including CHAMPUS & TRICARE))
CL Item
Veterans Sponsored (Veterans Sponsored)
CL Item
Self Pay (no Insurance) (Self Pay (No Insurance))
CL Item
No Means Of Payment (no Insurance) (No means of payment (no insurance))
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item Group
Race
Item
Race
text
C25372 (NCI Thesaurus ValueDomain)
C0034510 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C17049 (NCI Thesaurus Property)
CL.5
Code List
Race
CL Item
A Person Having Origins In Any Of The Original Peoples Of North And South America (including Central America), And Who Maintains Tribal Affiliation Or Community Attachment. (American Indian or Alaska Native)
C41259 (NCI Thesaurus)
C1515945 (UMLS 2011AA)
CL Item
A Person Having Origins In Any Of The Original Peoples Of The Far East, Southeast Asia, Or The Indian Subcontinent Including, For Example, Cambodia, China, India, Japan, Korea, Malaysia, Pakistan, The Philippine Islands, Thailand, And Vietnam. (Asian)
C41260 (NCI Thesaurus)
C0078988 (UMLS 2011AA)
CL Item
A Person Having Origins In Any Of The Black Racial Groups Of Africa. Terms Such As "haitian" Or "negro" Can Be Used In Addition To "black Or African American." (Black or African American)
C16352 (NCI Thesaurus)
C0085756 (UMLS 2011AA)
CL Item
A Person Having Origins In Any Of The Original Peoples Of Hawaii, Guam, Samoa, Or Other Pacific Islands. (Native Hawaiian or other Pacific Islander)
C41219 (NCI Thesaurus)
C1513907 (UMLS 2011AA)
CL Item
Not Provided Or Available (Not Reported)
C43234 (NCI Thesaurus)
C1706613 (UMLS 2011AA)
CL Item
Could Not Be Determined Or Unsure (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
CL Item
A Person Having Origins In Any Of The Original Peoples Of Europe, The Middle East, Or North Africa. (White)
C41261 (NCI Thesaurus)
C0007457 (UMLS 2011AA)
Item Group
Pre-treatment Requirements
PatientAgeInd-2
Item
Women or men >=18 years of age
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25150 (NCI Thesaurus Property)
C0001779 (UMLS 2011AA Property)
PatientAgeYearCount
Item
Age
float
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C29848 (NCI Thesaurus ValueDomain)
C0439234 (UMLS 2011AA ValueDomain)
C25463 (NCI Thesaurus ValueDomain-2)
C0750480 (UMLS 2011AA ValueDomain-2)
C25150 (NCI Thesaurus Property)
C0001779 (UMLS 2011AA Property)
Breast cancer, locally advanced or metastatic
Item
Histologically confirmed, locally advanced (a T4 primary tumor and stage IIIB or IIIC disease) or metastatic breast cancer that has progressed after treatment with regimens that included trastuzumab and either an anthracycline or a taxane or both. (NOTE: Agents need not have been given concurrently nor in the same regimen. NOTE: Prior treatment with trastuzumab is required unless there is a contraindication for trastuzumab treatment.)
boolean
C16960 (NCI Thesaurus ObjectClass)
C25581 (NCI Thesaurus Property)
C25411 (NCI Thesaurus Property-2)
C4872 (NCI Thesaurus Property-3)
C25171 (NCI Thesaurus Property-4)
C19987 (NCI Thesaurus Property-5)
C38147 (NCI Thesaurus ValueDomain)
C0205179 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
Trastuzumab treatment
Item
Prior treatment with trastuzumab in the neo-adjuvant, adjuvant, or metastatic setting is required. (NOTE: Prior treatment with trastuzumab is required unless there is a contraindication for trastuzumab treatment. - NOTE: Concomitant use of trastuzumab is not allowed in this study.)
boolean
C16960 (NCI Thesaurus ObjectClass)
C1647 (NCI Thesaurus Property)
C25629 (NCI Thesaurus Property-2)
C15675 (NCI Thesaurus Property-3)
C25171 (NCI Thesaurus Property-4)
C1490 (NCI Thesaurus Property-5)
C38147 (NCI Thesaurus ValueDomain)
C0338204 (UMLS CUI [1])
PriorBreastCarcinomaChemotherapyAdministeredIndicator
Item
Prior chemotherapy allowed in the neo-adjuvant, adjuvant, or metastatic setting. Unlimited prior chemotherapy is allowed.
boolean
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C4872 (NCI Thesaurus ObjectClass-3)
C0678222 (UMLS 2011AA ObjectClass-3)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
PatientBreastCarcinomaEndocrineTherapyAdministeredEligibilityDeterminationInd-2
Item
Prior hormonal therapy allowed in the neo-adjuvant, adjuvant, or metastatic setting. Unlimited prior hormonal therapy is allowed.
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C15445 (NCI Thesaurus Property)
C0279025 (UMLS 2011AA Property)
C4872 (NCI Thesaurus Property-2)
C0678222 (UMLS 2011AA Property-2)
C25171 (NCI Thesaurus Property-3)
C0013893 (UMLS 2011AA Property-3)
C25382 (NCI Thesaurus Property-4)
C1521801 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PatientHER2/neuPositiveFindingEligibilityDeterminationInd-2
Item
HER2 positive, defined as: Validated IHC assay score of 3+ (defined as uniform, intense staining of >30% of invasive tumor cells) -OR- Average HER2 gene copy number of >6 -OR- Gene amplified (HER2:D17Z1) ratio >2.20
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C38758 (NCI Thesaurus Property)
C1514241 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property-2)
C0013893 (UMLS 2011AA Property-2)
C17756 (NCI Thesaurus Property-3)
C0242957 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PatientMeasurableDiseaseResponseEvaluationCriteriainSolidTumorsEligibilityDeterminationInd-2
Item
Must have measurable disease according to RECIST criteria (See Section 11.0)
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C8507 (NCI Thesaurus Property)
C1513041 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property-2)
C0013893 (UMLS 2011AA Property-2)
C49164 (NCI Thesaurus Property-3)
C1709926 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Item
Negative pregnancy test done <=7 days prior to registration, for women of childbearing potential only. (If not a woman of childbearing potential check NA)
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25247 (NCI Thesaurus Property)
C0205160 (UMLS 2011AA Property)
C0032976 (NCI Metathesaurus Property)
CL.13
Code List
Negative pregnancy test done <=7 days prior to registration, for women of childbearing potential only. (If not a woman of childbearing potential check NA)
CL Item
N/a (N/A)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
PatientNegativePregnancyTestDate
Item
Negative pregnancy test date (If a woman of childbearing potential)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25247 (NCI Thesaurus Property)
C0205160 (UMLS 2011AA Property)
C0032976 (NCI Metathesaurus Property)
PatientPriorRegistrationLaboratoryProcedureEligibilityDeterminationInd-2
Item
The following laboratory values obtained <=7 days prior to registration
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25646 (NCI Thesaurus Property)
C1514821 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property-2)
C0332152 (UMLS 2011AA Property-2)
C25294 (NCI Thesaurus Property-3)
C0022885 (UMLS 2011AA Property-3)
C25171 (NCI Thesaurus Property-4)
C0013893 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
LaboratoryProcedureEvaluationPerformedFirstDate
Item
Earliest laboratory test date (Note: These dates pertain to the following labs only.)
date
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25214 (NCI Thesaurus Property)
C0220825 (UMLS 2011AA Property)
C38000 (NCI Thesaurus Property-2)
C0884358 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25509 (NCI Thesaurus ValueDomain-2)
C1279901 (UMLS 2011AA ValueDomain-2)
LaboratoryProcedureEvaluationPerformedMostRecentDate
Item
latest laboratory test date
date
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25214 (NCI Thesaurus Property)
C0220825 (UMLS 2011AA Property)
C38000 (NCI Thesaurus Property-2)
C0884358 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25577 (NCI Thesaurus ValueDomain-2)
C1513491 (UMLS 2011AA ValueDomain-2)
HematologyHemoglobinAssessmentInd-2
Item
Hemoglobin >9.0 g/dL
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C16673 (NCI Thesaurus ObjectClass)
C0018943 (UMLS 2011AA ObjectClass)
Hemoglobin
Item
Hemoglobin
float
C16676 (NCI Thesaurus Property)
C0019046 (UMLS CUI-1)
C20200 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
LaboratoryProcedureLeukocyteEligibilityDeterminationInd-2
Item
WBC >= 3,000/mL
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C12529 (NCI Thesaurus Property)
C0023516 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25171 (NCI Thesaurus Property-2)
C0013893 (UMLS 2011AA Property-2)
Leukocytes (WBC)
Item
WBC
float
C25294 (NCI Thesaurus ObjectClass)
C0023508 (UMLS CUI-1)
C12529 (NCI Thesaurus Property)
C20200 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
LaboratoryProcedureAbsoluteNeutrophilCountEligibilityDeterminationInd-2
Item
ANC >= 1500/mL
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C63321 (NCI Thesaurus Property)
C0948762 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25171 (NCI Thesaurus Property-2)
C0013893 (UMLS 2011AA Property-2)
ANC
Item
ANC
float
C25294 (NCI Thesaurus ObjectClass)
C0948762 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C63321 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
LaboratoryProcedurePlateletCountEligibilityDeterminationInd-2
Item
Platelet Count >= 75,000/mL
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C51951 (NCI Thesaurus Property)
C0032181 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property-2)
C0013893 (UMLS 2011AA Property-2)
Platelets
Item
Platelet count
float
C25294 (NCI Thesaurus ObjectClass)
C0005821 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C12520 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
LaboratoryProcedureWithinClinicalStudyProtocolUpperLimitofNormalTotalBilirubinMeasurementInd-2
Item
Total bilirubin <= 1.5 x ULN
boolean
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25320 (NCI Thesaurus Property)
C1507394 (UMLS 2011AA Property)
C38037 (NCI Thesaurus Property-2)
C0201913 (UMLS 2011AA Property-2)
C25282 (NCI Thesaurus Property-3)
C0332285 (UMLS 2011AA Property-3)
C25706 (NCI Thesaurus Property-4)
C1519815 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Bilirubin, Total
Item
Total Bilirubin
float
C25294 (NCI Thesaurus ObjectClass)
C0201913 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C38037 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
Bilirubin, Total ULN
Item
Total Bilirubin ULN
float
C25294 (NCI Thesaurus ObjectClass)
C0201913 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C1519815 (UMLS CUI-2)
C38037 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
AST and ALT below 2.5xULN
Item
SGOT(AST) and SGPT(ALT) <=2.5 x ULN or SGOT(AST) and SGPT(ALT) <5 x ULN if elevations are due to liver metastases.
boolean
C25294 (NCI Thesaurus ObjectClass)
C25202 (NCI Thesaurus Property)
C25171 (NCI Thesaurus Property-2)
C25293 (NCI Thesaurus Property-3)
C38147 (NCI Thesaurus ValueDomain)
C0242192 (UMLS CUI [1,1])
C0376147 (UMLS CUI [1,2])
AST and ALT above 2.5xULN
Item
SGOT(AST) and SGPT(ALT) >2.5 x ULN due to liver metastases (This question may be answered "Yes" or "No")
boolean
C25294 (NCI Thesaurus ObjectClass)
C25202 (NCI Thesaurus Property)
C25171 (NCI Thesaurus Property-2)
C25293 (NCI Thesaurus Property-3)
C4758 (NCI Thesaurus Property-4)
C38147 (NCI Thesaurus ValueDomain)
C0242192 (UMLS CUI [1,1])
C0376147 (UMLS CUI [1,2])
C0494165 (UMLS CUI [1,3])
AST
Item
AST (SGOT)
float
C25202 (NCI Thesaurus Property)
C20200 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C0201899 (UMLS CUI [1])
AST ULN
Item
AST (SGOT) ULN
float
C25294 (NCI Thesaurus ObjectClass)
C25202 (NCI Thesaurus Property)
C20200 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C0242192 (UMLS CUI [1,1])
C1519815 (UMLS CUI [1,2])
ALT
Item
ALT (SGPT)
float
C25294 (NCI Thesaurus ObjectClass)
C20200 (NCI Thesaurus Property)
C25293 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C0201836 (UMLS CUI [1])
ALT ULN
Item
ALT (SGPT) ULN
float
C25294 (NCI Thesaurus ObjectClass)
C20200 (NCI Thesaurus Property)
C25293 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C0376147 (UMLS CUI [1,1])
C1519815 (UMLS CUI [1,2])
Creatinine below 1.5xULN
Item
Serum Creatinine <=1.5 x ULN
boolean
C38147 (NCI Thesaurus ValueDomain)
C399 (NCI Thesaurus Property)
C25294 (NCI Thesaurus ObjectClass)
C25171 (NCI Thesaurus Property-2)
C0010294 (UMLS CUI [1])
Creatinine, Serum
Item
Creatinine
float
C25294 (NCI Thesaurus ObjectClass)
C20200 (NCI Thesaurus Property)
C399 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C0201976 (UMLS CUI [1])
Creatinine, serum ULN
Item
Serum Creatinine ULN
float
C25294 (NCI Thesaurus ObjectClass)
C0201976 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C1519815 (UMLS CUI-2)
C399 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
Creatinine clearance above 30mL/min
Item
Creatinine clearance >=30 mL/min (calculated according to Cockcroft and Gault - see Appendix II)
boolean
C38147 (NCI Thesaurus ValueDomain)
C25747 (NCI Thesaurus Property)
C25294 (NCI Thesaurus ObjectClass)
C25171 (NCI Thesaurus Property-2)
C0373595 (UMLS CUI [1])
Creatinine Clearance
Item
Creatinine Clearance
float
C20200 (NCI Thesaurus Property)
C25747 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C0373595 (UMLS CUI [1])
LaboratoryProcedureFastingPlasmaGlucoseMeasurementEligibilityDeterminationInd-2
Item
Fasting glucose <120 mg/dL (NOTE: Patients with diabetes are allowed to participate, provided that their blood glucose is within the guidelines above upon enrollment.)
boolean
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C41376 (NCI Thesaurus Property)
C0202042 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property-2)
C0013893 (UMLS 2011AA Property-2)
C63663 (NCI Thesaurus Property-3)
C0015663 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Fasting glucose
Item
Fasting glucose
float
C25294 (NCI Thesaurus ObjectClass)
C20200 (NCI Thesaurus Property)
C41376 (NCI Thesaurus Property-2)
C63663 (NCI Thesaurus Property-3)
C25712 (NCI Thesaurus ValueDomain)
C0202045 (UMLS CUI [1])
INR below 1.5xULN
Item
International Normalization Ratio (INR) <= 1.5 X ULN
boolean
C38147 (NCI Thesaurus ValueDomain)
C25294 (NCI Thesaurus ObjectClass)
C25352 (NCI Thesaurus Property)
C25171 (NCI Thesaurus Property-2)
C0525032 (UMLS CUI [1])
INR
Item
International Normalization Ratio (INR)
float
C20200 (NCI Thesaurus Property)
C0525032 (UMLS CUI-1)
C25294 (NCI Thesaurus ObjectClass)
C25352 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
INR ULN
Item
International Normalized Ratio ULN
float
C25294 (NCI Thesaurus ObjectClass)
C20200 (NCI Thesaurus Property)
C25352 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C0525032 (UMLS CUI [1,1])
C1519815 (UMLS CUI [1,2])
ECOG 0-2
Item
ECOG performance status 0, 1, or 2
boolean
C38147 (NCI Thesaurus ValueDomain)
C20989 (NCI Thesaurus Property)
C25491 (NCI Thesaurus ObjectClass)
CL092952 (NCI Metathesaurus ObjectClass)
C1512162 (UMLS CUI [1])
Item
Performance Status
text
C25664 (NCI Thesaurus ValueDomain)
C1520224 (UMLS CUI-1)
C25367 (NCI Thesaurus Property)
C25491 (NCI Thesaurus ValueDomain-2)
C20641 (NCI Thesaurus ObjectClass)
CL.27
Code List
Performance Status
CL Item
Fully Active, Able To Carry On All Pre-disease Performance Without Restriction. (0)
CL Item
Restricted In Physically Strenuous Activity But Ambulatory And Able To Carry Out Work Of A Light Or Sedentary Nature, E.g., Light Housework, Office Work. (1)
CL Item
Ambulatory And Capable Of All Selfcare But Unable To Carry Out Any Work Activities. Up And About More Than 50% Of Waking Hours. (2)
CL Item
Capable Of Only Limited Selfcare, Confined To Bed Or Chair More Than 50% Of Waking Hours. (3)
CL Item
Completely Disabled. Cannot Carry On Any Selfcare. Totally Confined To Bed Or Chair. (4)
CL Item
Dead (5)
PatientCardiacFunctionRequiredInd-2
Item
Adequate cardiac function as defined as an ejection fraction 50% as determined by MUGA or echocardiogram
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25518 (NCI Thesaurus Property)
C0542341 (UMLS 2011AA Property)
PatientLifeExpectancyEligibilityDeterminationInd-2
Item
Life expectancy >3 months
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C37987 (NCI Thesaurus Property)
C0376558 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property-2)
C0013893 (UMLS 2011AA Property-2)
C25359 (NCI Thesaurus Property-3)
C0679138 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Consent signed
Item
Has written informed consent been obtained
boolean
C38147 (NCI Thesaurus ValueDomain)
C0742766 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25678 (NCI Thesaurus Property)
C25460 (NCI Thesaurus Property-2)
PatientTherapeuticProcedureFollow-upEligibilityDeterminationInd-2
Item
Willingness to return to an NCCTG or other participating cooperative group institution for treatment and follow-up
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C16033 (NCI Thesaurus Property)
C1522577 (UMLS 2011AA Property)
C49236 (NCI Thesaurus Property-2)
C0087111 (UMLS 2011AA Property-2)
C25171 (NCI Thesaurus Property-3)
C0013893 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PersonSpecimenUseConsentEligibilityDeterminationIndicator
Item
Patient willing to provide tissue and blood samples for research purposes (see Sections 6.0 14.0 and 17.0)
boolean
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus Property)
C0370003 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property-2)
C0013893 (UMLS 2011AA Property-2)
C25460 (NCI Thesaurus Property-3)
C1511481 (UMLS 2011AA Property-3)
C25340 (NCI Thesaurus Property-4)
C0457083 (UMLS 2011AA Property-4)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
EvaluationDiagnosticSpecimenPathologyReportEligibilityDeterminationind-2
Item
Availability of diagnostic material (i.e., diagnostic slides confirming locally advanced/metastatic disease and HER2 stained slides) and operative and pathology reports from diagnosis of locally advanced or metastatic breast cancer (NOTE: Biopsy of recurrent disease and submission of these materials is not required if materials available from initial diagnosis of locally advanced/metastatic disease.)
boolean
C25214 (NCI Thesaurus ObjectClass)
C0220825 (UMLS 2011AA ObjectClass)
C25482 (NCI Thesaurus ObjectClass-2)
C0348026 (UMLS 2011AA ObjectClass-2)
C28277 (NCI Thesaurus Property)
C0807321 (UMLS 2011AA Property)
C19157 (NCI Thesaurus Property-2)
C0370003 (UMLS 2011AA Property-2)
C25171 (NCI Thesaurus Property-3)
C0013893 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PatientQuestionnaireCompleteEligibilityDeterminationInd-2
Item
Ability to complete questionnaire(s) by themselves or with assistance (All responses in above section must be "Yes" unless specified as "NA.")
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C17048 (NCI Thesaurus Property-2)
C0034394 (UMLS 2011AA Property-2)
C25171 (NCI Thesaurus Property-3)
C0013893 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Item Group
Exclusion Criteria
PatientReproductionPregnancyBreastFeedingExclusionCriteriaInd-2
Item
Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus newborn are unknown: - Pregnant women - Nursing women - Men or women of childbearing potential who are unwilling to employ adequate contraception (as determined by the treating physician).
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25742 (NCI Thesaurus Property)
C0032961 (UMLS 2011AA Property)
C25370 (NCI Thesaurus Property-2)
C0680251 (UMLS 2011AA Property-2)
C25596 (NCI Thesaurus Property-3)
C0006147 (UMLS 2011AA Property-3)
C17087 (NCI Thesaurus Property-4)
C0035150 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PatientAdvancedMalignantNeoplasmPriorRegistrationEligibilityDeterminationInd-2
Item
Stage III or IV invasive cancer, other than breast cancer, in <=5 years prior to registration.
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25646 (NCI Thesaurus Property)
C1514821 (UMLS 2011AA Property)
C25411 (NCI Thesaurus Property-2)
C0205179 (UMLS 2011AA Property-2)
C9305 (NCI Thesaurus Property-3)
C0006826 (UMLS 2011AA Property-3)
C25629 (NCI Thesaurus Property-4)
C0332152 (UMLS 2011AA Property-4)
C25171 (NCI Thesaurus Property-5)
C0013893 (UMLS 2011AA Property-5)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PatientCurrentTherapeuticProcedureMalignantNeoplasmExclusionCriteriaInd-2
Item
Actively being treated for other malignancy, excepting non-melanotic skin cancer or carcinoma-in-situ of the cervix (If there is a history of prior malignancy, they must not be receiving other specific treatment for their cancer.)
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25471 (NCI Thesaurus Property)
C0521116 (UMLS 2011AA Property)
C9305 (NCI Thesaurus Property-2)
C0006826 (UMLS 2011AA Property-2)
C49236 (NCI Thesaurus Property-3)
C0087111 (UMLS 2011AA Property-3)
C25370 (NCI Thesaurus Property-4)
C0680251 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PatientNewYorkHeartAssociationClassIII/IVEligibilityDeterminationInd-2
Item
New York Heart Association class III or IV cardiovascular disease
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
C7922 (NCI Thesaurus Property-2)
C0278962 (UMLS 2011AA Property-2)
PatientCurrentHepaticDisorderBiliaryDiseaseorDisorderExclusionCriteriaInd-2
Item
Current, active hepatic or biliary disease except Gilbert's syndrome or asymptomatic gallstones
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25471 (NCI Thesaurus Property)
C0521116 (UMLS 2011AA Property)
C2991 (NCI Thesaurus Property-2)
C0012634 (UMLS 2011AA Property-2)
C3196 (NCI Thesaurus Property-3)
C0023895 (UMLS 2011AA Property-3)
C25370 (NCI Thesaurus Property-4)
C0680251 (UMLS 2011AA Property-4)
C28011 (NCI Thesaurus Property-5)
C0521378 (UMLS 2011AA Property-5)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PatientMetastaticMalignantNeoplasmtotheBrainExclusionCriteriaInd-2
Item
Evidence of active brain metastasis including leptomeningeal involvement. CNS metastasis controlled by prior surgery and/or radiotherapy is allowed. (NOTE: To be considered controlled, there must be at least 2 months of no symptoms or evidence of progression prior to study entry and corticosteriod therapy must have been discontinued.)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C3813 (NCI Thesaurus Property)
C0220650 (UMLS 2011AA Property)
C25370 (NCI Thesaurus Property-2)
C0680251 (UMLS 2011AA Property-2)
PatientSurgicalProcedureChemotherapyImmunotherapyPriorRegistrationExclusionCriteriaInd-2
Item
Major surgery, chemotherapy, or immunologic therapy <=6 weeks prior to registration
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25646 (NCI Thesaurus Property)
C1514821 (UMLS 2011AA Property)
C15632 (NCI Thesaurus Property-2)
C0392920 (UMLS 2011AA Property-2)
C15262 (NCI Thesaurus Property-3)
C0021083 (UMLS 2011AA Property-3)
C15329 (NCI Thesaurus Property-4)
C0543467 (UMLS 2011AA Property-4)
C25629 (NCI Thesaurus Property-5)
C0332152 (UMLS 2011AA Property-5)
C25370 (NCI Thesaurus Property-6)
C0680251 (UMLS 2011AA Property-6)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PatientRadiationTherapyPriorRegistrationExclusionCriteriaInd-2
Item
Radiotherapy <=4 weeks prior to registration, except if to a non-target lesion only. Prior radiation to a target lesion is permitted only if there has been clear progression of the lesion since radiation was completed. (If patient receives single dose radiation for palliation or radiation to non-target lesion, they may immediately proceed to registration without waiting 4 weeks. Acute adverse events from radiation must have resolved to <=CTCAE v3.0 Grade 1.)
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25646 (NCI Thesaurus Property)
C1514821 (UMLS 2011AA Property)
C15313 (NCI Thesaurus Property-2)
C1522449 (UMLS 2011AA Property-2)
C25629 (NCI Thesaurus Property-3)
C0332152 (UMLS 2011AA Property-3)
C25370 (NCI Thesaurus Property-4)
C0680251 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PatientInsulin-LikeGrowthFactorTherapeuticProcedureExclusionCriteriaInd-2
Item
Prior treatment with any therapy targeting IGF-I, IGF-II or its receptors(either monoclonal antibody or tyrosine kinase inhibitor), including but not limited to any of the following (which would have been received on a previous clinical trial): - IMC-A12 (cixutumumab) - CP-751,871 (figitumumab) - AMG-479 - INSM-18 - MK0646 (h7C10) - SCH717454 (19D12, robatumumab) - R1507 - OSI-906 - BMS-754807 - PPP - NVP-AEW541 - AVE-1642 - MEDI-573
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C49236 (NCI Thesaurus Property)
C0087111 (UMLS 2011AA Property)
C25370 (NCI Thesaurus Property-2)
C0680251 (UMLS 2011AA Property-2)
C20442 (NCI Thesaurus Property-3)
C0037657 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Prior therapy HER1 or HER2 other than Trastuzumab
Item
Prior therapy with any therapy targeting HER1 (EGFR) and/or HER2 (either monoclonal antibody or tyrosine kinase) other than trastuzumab, including but not limited to any of the following: (lapatinib Tykerb, gefitinib Iressa, erlotinib Tarveca, cetuximab Erbitux, panitumumab Vectibix)
boolean
C16960 (NCI Thesaurus ObjectClass)
C49236 (NCI Thesaurus Property)
C17068 (NCI Thesaurus Property-2)
C25370 (NCI Thesaurus Property-3)
C17319 (NCI Thesaurus Property-4)
C38147 (NCI Thesaurus ValueDomain)
C0087111 (UMLS CUI [1,1])
C0034802 (UMLS CUI [1,2])
C0069515 (UMLS CUI [1,3])
PatientContraindicatedAgentExclusionCriteriaInd-2
Item
Currently receiving treatment with any agents that are contraindicated by study therapies: A) IMC-A12 - none identified to date B) Lapatinib - CYPA34 inhibitors and inducers (see Appendix IV) including grapefruit and grapefruit juice (C Capecitabine - warfarinCoumadin, cimetidineTagamet, allopurinolLopurin, sorivudineUsevir, brivudineBrivex, ketoconazoleNizoral, itraconazoleSporanox, ritonavirNorvir, amprenavirAgenerase, or indinavirCrixivan)
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus Property)
C0450442 (UMLS 2011AA Property)
C25370 (NCI Thesaurus Property-2)
C0680251 (UMLS 2011AA Property-2)
C37933 (NCI Thesaurus Property-3)
C1444657 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PatientUncontrolledConcurrentDiseaseorDisorderExclusionCriteriaInd-2
Item
Uncontrolled intercurrent illness (including, but not limited to: - Poorly controlled diabetes - Ongoing or active infection - Symptomatic congestive heart failure - Unstable angina pectoris - Cardiac arrhythmia - Psychiatric illness/social situations that would limit compliance with study requirements)
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C2991 (NCI Thesaurus Property)
C0012634 (UMLS 2011AA Property)
C25456 (NCI Thesaurus Property-2)
C0205420 (UMLS 2011AA Property-2)
C48932 (NCI Thesaurus Property-3)
C0205318 (UMLS 2011AA Property-3)
C25370 (NCI Thesaurus Property-4)
C0680251 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PatientConcurrentSystemicDiseaseorDisorderExclusionCriteriaInd-2
Item
Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of the safety (of the prescribed regimens.)
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C13310 (NCI Thesaurus Property)
C0205373 (UMLS 2011AA Property)
C2991 (NCI Thesaurus Property-2)
C0012634 (UMLS 2011AA Property-2)
C25456 (NCI Thesaurus Property-3)
C0205420 (UMLS 2011AA Property-3)
C25370 (NCI Thesaurus Property-4)
C0680251 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PatientInvestigationalClinicalTrialCurrentParticipationExclusionCriteriaInd-2
Item
Currently receiving treatment in a different clinical study in which investigational procedures are performed or investigational therapies are administered
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25608 (NCI Thesaurus Property)
C0679823 (UMLS 2011AA Property)
C25471 (NCI Thesaurus Property-2)
C0521116 (UMLS 2011AA Property-2)
C15207 (NCI Thesaurus Property-3)
C28041 (NCI Thesaurus Property-4)
C1517586 (UMLS 2011AA Property-3)
C25370 (NCI Thesaurus Property-5)
C0680251 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PatientImmunocompromisedExclusionCriteriaind-2
Item
Immunocompromised patients (other than that related to the use of corticosteroids) including patients known to be HIV positive with an AIDS-defining illness. (HIV positive patients with CD4 count within institutional normal range and no history of an AIDS-defining illness are eligible, however, some antiviral/antiretroviral medications which have CYP3A4 interactions are prohibited on this study.)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25370 (NCI Thesaurus Property)
C0680251 (UMLS 2011AA Property)
C14139 (NCI Thesaurus Property-2)
C0085393 (UMLS 2011AA Property-2)
Item Group
Registration Check
InformedConsentFormSignedInd-2
Item
Consent form signed and dated
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16468 (NCI Thesaurus ObjectClass)
C0009797 (UMLS 2011AA ObjectClass)
C25679 (NCI Thesaurus Property)
InformedConsentFormSignedDate
Item
Date Informed Consent Signed
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
C16468 (NCI Thesaurus ObjectClass)
C0009797 (UMLS 2011AA ObjectClass)
C25679 (NCI Thesaurus Property)
Item
Authorization for use and disclosure of protected health information signed and dated (Non-USA institution only check NA)
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25178 (NCI Thesaurus Property)
C0018684 (UMLS 2011AA Property)
CL.51
Code List
Authorization for use and disclosure of protected health information signed and dated (Non-USA institution only check NA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
Not Applicable (Not Applicable)
C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)
C48660 (NCI Thesaurus-3)
C1272460 (UMLS 2011AA-4)
PatientSignedDischargeMedicalRecordDate
Item
Date of authorization
date
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25679 (NCI Thesaurus Property)
C0012621 (NCI Metathesaurus Property)
C45258 (NCI Thesaurus Property-2)
C0025102 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
PatientRegisteredInd-2
Item
A mandatory translational research component is part of this study, patients will automatically be registered to the translational research component of this study at the time of registration. (see Section 14.0 and 17.0)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25644 (NCI Thesaurus Property)
ClinicalTrialTherapeuticProcedurePostRegistrationChecklistInd-2
Item
Treatment cannot begin prior to registration and must begin <=7 days after registration
boolean
C15207 (NCI Thesaurus ObjectClass)
C25646 (NCI Thesaurus Property)
C1514821 (UMLS 2011AA Property)
C38008 (NCI Thesaurus Property-2)
C0687676 (UMLS 2011AA Property-2)
C49236 (NCI Thesaurus Property-3)
C0087111 (UMLS 2011AA Property-3)
C49073 (NCI Thesaurus Property-4)
C1707357 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PatientPriorRegistrationLaboratoryProcedureVerificationInd-2
Item
Pretreatment tests/procedures must be completed <= 7 days prior to registration (NOTE: The earliest pretreatment test/procedure date must be less than or equal to the earliest laboratory test/procedure date and the latest pretreatment test/procedure date must be greater than or equal to the latest laboratory test/procedure date.)
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25646 (NCI Thesaurus Property)
C1514821 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property-2)
C0332152 (UMLS 2011AA Property-2)
C25294 (NCI Thesaurus Property-3)
C0022885 (UMLS 2011AA Property-3)
C45513 (NCI Thesaurus Property-4)
C1711411 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PatientPriorRegistrationLaboratoryProcedureEligibilityDeterminationBeginDate
Item
Earliest pretreatment test/procedure date
date
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25646 (NCI Thesaurus Property)
C1514821 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property-2)
C0332152 (UMLS 2011AA Property-2)
C25294 (NCI Thesaurus Property-3)
C0022885 (UMLS 2011AA Property-3)
C25171 (NCI Thesaurus Property-4)
C0013893 (UMLS 2011AA Property-4)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)
C0439659 (UMLS 2011AA ValueDomain-2)
PatientPriorRegistrationLaboratoryProcedureEligibilityDeterminationEndDate
Item
Latest pretreatment test/procedure date
date
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25646 (NCI Thesaurus Property)
C1514821 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property-2)
C0332152 (UMLS 2011AA Property-2)
C25294 (NCI Thesaurus Property-3)
C0022885 (UMLS 2011AA Property-3)
C25171 (NCI Thesaurus Property-4)
C0013893 (UMLS 2011AA Property-4)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
PatientPriorRegistrationDiagnosticImagingEligibilityDeterminationBeginDate
Item
Earliest exception test date (Tumor measurement, Chest x-ray or CT, Bone scan, Brain MRI or CT, must be done <=21 days prior to registration see Section 4.0.)
date
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C16502 (NCI Thesaurus Property)
C0011923 (UMLS 2011AA Property)
C25646 (NCI Thesaurus Property-2)
C1514821 (UMLS 2011AA Property-2)
C25629 (NCI Thesaurus Property-3)
C0332152 (UMLS 2011AA Property-3)
C25171 (NCI Thesaurus Property-4)
C0013893 (UMLS 2011AA Property-4)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)
C0439659 (UMLS 2011AA ValueDomain-2)
PatientPriorRegistrationDiagnosticImagingEligibilityDeterminationEndDate
Item
latest exception test date
date
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C16502 (NCI Thesaurus Property)
C0011923 (UMLS 2011AA Property)
C25646 (NCI Thesaurus Property-2)
C1514821 (UMLS 2011AA Property-2)
C25629 (NCI Thesaurus Property-3)
C0332152 (UMLS 2011AA Property-3)
C25171 (NCI Thesaurus Property-4)
C0013893 (UMLS 2011AA Property-4)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
DiagnosticElectrocardiogramPerformedDate
Item
Date of EKG (Electrocardiogram EKG must be done <=28 days prior to registration see Section 4.0.)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25482 (NCI Thesaurus ObjectClass)
C0348026 (UMLS 2011AA ObjectClass)
C0013798 (NCI Metathesaurus ObjectClass)
ClinicalTrialBaselineDiseaseDocumentedChecklistInd-2
Item
All required baseline symptoms (see Section 10.3) must be documented and graded
boolean
C15207 (NCI Thesaurus ObjectClass)
C25213 (NCI Thesaurus Property)
C1442488 (UMLS 2011AA Property)
C2991 (NCI Thesaurus Property-2)
C0012634 (UMLS 2011AA Property-2)
C25356 (NCI Thesaurus Property-3)
C1301725 (UMLS 2011AA Property-3)
C49073 (NCI Thesaurus Property-4)
C1707357 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
ClinicalTrialProtocolAgentAvailabilityChecklistInd-2
Item
Study drug availability checked (Study drug must be in site pharmacy for this patient prior to registration)
boolean
C15207 (NCI Thesaurus ObjectClass)
C41161 (NCI Thesaurus Property)
C1521826 (UMLS 2011AA Property)
C25429 (NCI Thesaurus Property-2)
C0470187 (UMLS 2011AA Property-2)
C49073 (NCI Thesaurus Property-3)
C1707357 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
ClinicalTrialBloodSpecimenCollectionAvailabilityChecklistInd-2
Item
Blood draw kit availability checked (Site must have a kit on hand for this patient prior to registration)
boolean
C15207 (NCI Thesaurus ObjectClass)
C12434 (NCI Thesaurus Property)
C0229664 (UMLS 2011AA Property)
C25453 (NCI Thesaurus Property-2)
C1516698 (UMLS 2011AA Property-2)
C19157 (NCI Thesaurus Property-3)
C0370003 (UMLS 2011AA Property-3)
C25429 (NCI Thesaurus Property-4)
C0470187 (UMLS 2011AA Property-4)
C49073 (NCI Thesaurus Property-5)
C1707357 (UMLS 2011AA Property-5)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
ClinicalTrialQualityAssuranceERBB2ReceptorProtein-TyrosineKinaseDiagnosisChecklistInd-2
Item
This protocol has a mandatory quality assurance (QA) audit submission of diagnostic slides and HER2 stained slides used to make a HER2 positive metastatic breast cancer diagnosis, plus corresponding operating and pathology reports (If these materials are not available, the patient is not eligible for this trial)
boolean
C15207 (NCI Thesaurus ObjectClass)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C49073 (NCI Thesaurus Property-2)
C1707357 (UMLS 2011AA Property-2)
C17319 (NCI Thesaurus Property-3)
C0069515 (UMLS 2011AA Property-3)
C15381 (NCI Thesaurus Property-4)
C0178932 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
ClinicalTrialQualityofLifeAvailabilityChecklistInd-2
Item
Patient QOL booklet availability checked; copies are not acceptable for this submission (Site must have booklets on hand for this patient prior to registration)
boolean
C15207 (NCI Thesaurus ObjectClass)
C17047 (NCI Thesaurus Property)
C0518214 (UMLS 2011AA Property)
C25429 (NCI Thesaurus Property-2)
C0470187 (UMLS 2011AA Property-2)
C49073 (NCI Thesaurus Property-3)
C1707357 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
ClinicalTrialStudyMonitorChecklistInd-2
Item
This protocol has mandatory monitoring for the Safety Cohort - sites must participate in monthly conference calls (see Section 16.8.4)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C15207 (NCI Thesaurus ObjectClass)
C49073 (NCI Thesaurus Property)
C1707357 (UMLS 2011AA Property)
C41201 (NCI Thesaurus Property-2)
C1521743 (UMLS 2011AA Property-2)
Item Group
At The Time Of Registration/randomization, The Following Will Also Be Recorded:
PersonSpecimenMalignantNeoplasmResearchConsentInd-2
Item
Patient has given permission to keep sample(s) for use in future research to learn about, prevent, or treat cancer
boolean
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C15319 (NCI Thesaurus Property)
C9305 (NCI Thesaurus Property-2)
C0006826 (UMLS 2011AA Property)
C19157 (NCI Thesaurus Property-3)
C0370003 (UMLS 2011AA Property-2)
C25460 (NCI Thesaurus Property-4)
C1511481 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
BloodTissueSpecimenOtherDiseasesandDisordersResearchConsentInd-3
Item
Patient has given permission to keep sample(s) for use in future research to learn about, prevent, or treat other health problems (for example: diabetes, Alzheimer's disease, or heart disease)
boolean
C12801 (NCI Thesaurus ObjectClass)
C0040300 (UMLS 2011AA ObjectClass)
C12434 (NCI Thesaurus ObjectClass-2)
C0229664 (UMLS 2011AA ObjectClass-2)
C19157 (NCI Thesaurus ObjectClass-3)
C0370003 (UMLS 2011AA ObjectClass-3)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C15319 (NCI Thesaurus Property-2)
C2991 (NCI Thesaurus Property-3)
C0012634 (UMLS 2011AA Property-2)
C25460 (NCI Thesaurus Property-4)
C1511481 (UMLS 2011AA Property-3)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
PersonSpecimenExternalInvestigatorConsentInd-2
Item
Patient has given NCCTG permission to give sample(s) to outside researchers
boolean
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C44280 (NCI Thesaurus Property)
C0205101 (UMLS 2011AA Property)
C19157 (NCI Thesaurus Property-2)
C0370003 (UMLS 2011AA Property-2)
C25936 (NCI Thesaurus Property-3)
C0035173 (UMLS 2011AA Property-3)
C25460 (NCI Thesaurus Property-4)
C1511481 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Item Group
Stratification Factors
Item
Receptor Status (Hormone)
text
C12971 (NCI Thesaurus ObjectClass)
C0006141 (UMLS 2011AA ObjectClass)
C17220 (NCI Thesaurus ObjectClass-2)
C0041365 (UMLS 2011AA ObjectClass-2)
C28154 (NCI Thesaurus ObjectClass-3)
C0019929 (UMLS 2011AA ObjectClass-3)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C15220 (NCI Thesaurus Property-2)
C0011900 (UMLS 2011AA Property-2)
C25508 (NCI Thesaurus Property-3)
C0205088 (UMLS 2011AA Property-3)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.64
Code List
Receptor Status (Hormone)
CL Item
Er Or Pgr Positive (ER or PgR positive)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
Item
Number of prior chemotherapy regimens in the metastatic setting
text
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C14174 (NCI Thesaurus Property)
C0036525 (UMLS 2011AA Property)
C15697 (NCI Thesaurus Property-2)
C0040808 (UMLS 2011AA Property-2)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
CL.65
Code List
Number of prior chemotherapy regimens in the metastatic setting
CL Item
Two Or More (Two or more)
CL Item
One (One)
C66832 (NCI Thesaurus)
C0205447 (UMLS 2011AA)
CL Item
None (None)
C41132 (NCI Thesaurus)
C0549184 (UMLS 2011AA)
Item
Subgroup Code
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25693 (NCI Thesaurus ObjectClass-2)
C1515021 (UMLS 2011AA ObjectClass-2)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
C25689 (NCI Thesaurus Property-2)
C1514983 (UMLS 2011AA Property-2)
C25447 (NCI Thesaurus Property-3)
C1521970 (UMLS 2011AA Property-3)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.66
Code List
Subgroup Code
CL Item
Er/pgr+, Two Prior Regimens (SG01: ER/PgR+, two prior reg.)
CL Item
Er/pgr+, One Prior Regimen (SG02: ER/PgR+, one prior reg.)
CL Item
Er/pgr+, No Prior Regimens (SG03: ER/PgR+, no prior reg.)
CL Item
Other, Two Prior Regimens (SG04: Other, two prior reg.)
CL Item
Other, One Prior Regimen (SG05: Other, one prior reg.)
CL Item
Other, No Prior Regimen (SG06: Other, none prior reg.)
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