ID

12115

Description

Eligibility Breast Cancer Panobinostat and Letrozole NCT01105312 N093B 3303518v1.0 Breast Cancer NCT01105312 Eligibility - NCCTG Eligibility Checklist N093B - 3303518v1.0 NCCTG Eligibility Checklist N093B Panobinostat and Letrozole in Treating Patients With Metastatic Breast Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=B1C93F5C-1300-C2C0-E040-BB89AD4348C9

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=B1C93F5C-1300-C2C0-E040-BB89AD4348C9

Keywords

Versions (4)
  1. 8/27/12 8/27/12 -
  2. 7/10/15 7/10/15 - Martin Dugas
  3. 9/24/15 9/24/15 - Martin Dugas
  4. 9/20/21 9/20/21 -
Uploaded on

September 24, 2015

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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Eligibility Breast Cancer Panobinostat and Letrozole NCT01105312 N093B 3303518v1.0

English

No Instruction available.

1 forms  
  1. StudyEvent: NCCTG Eligibility Checklist N093B
    1. No Instruction available.
Pre-treatment Requirements
Description

Pre-treatment Requirements

Age >= 18 years
Description

Age >= 18 years

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25150
UMLS CUI [1]
C0001779
Age
Description

Age

Data type

integer

Alias
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus ValueDomain
C29848
NCI Thesaurus ValueDomain-2
C25463
NCI Thesaurus Property
C25150
UMLS CUI-1
C0001779
Histologic proof of metastatic breast cancer that is unresected at registration (with no intention of resecting tumors during this study). Evidence of metastatic breast cancer confirmed by radiological imaging
Description

PersonMetastaticUnresectedBreastCarcinomaClinicalTrialsEligibilityCriteriaInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C25190
NCI Thesaurus Property
C14174
NCI Thesaurus Property-2
C4872
NCI Metathesaurus Property
CL008804
NCI Thesaurus Property-3
C94255
NCI Thesaurus ValueDomain
C38147
UMLS CUI-1
C0036525
UMLS CUI-2
C0678222
Measurable disease (see Section 11.21 for definition of measurable disease)
Description

MeasurableDiseasePresentInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
NCI Thesaurus ObjectClass-2
C37894
UMLS 2011AA ObjectClass-2
C1513040
Metastatic site(s) must be amenable to biopsy
Description

PersonMetastasisPossibleBiopsyClinicalTrialEligibilityCriteriaInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C15189
UMLS 2011AA Property
C0005558
NCI Thesaurus Property-2
C19151
UMLS 2011AA Property-2
C0027627
NCI Thesaurus Property-3
C16112
UMLS 2011AA Property-3
C1516637
NCI Thesaurus Property-4
C82490
UMLS 2011AA Property-4
C0332149
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Post-menopausal according to any one of the following criteria: a. Age >60 years old b. Age >45 years old with last menstrual period >12 months prior to registration and estriadiol and folliclestimulating hormone (FSH) levels in postmenopausal range (per institutional normal limits) c. Bilateral oophorectomy If male (check NA).
Description

PatientPostMenopauseIndicator

Data type

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C15421
UMLS 2011AA Property
C0232970
Tumor estrogen, progesterone and HER2 [tested by IHC or FISH (fluorescent in situ hybridization)] status from the metastatic site. If not available, the results from the original tumor diagnosing the primary breast cancer may be used.- Triple negative disease only [ER- (defined as =<1% by IHC), PR- (defined as =<1% by IHC), and HER2-] Patients with triple negative breast cancer are allowed if there is clinical or radiographic evidence of tumor progression in the adjuvant or metastatic setting. (Note: If HER2 result by IHC is 2+ equivocal, the tumor must be confirmed to be HER2- by FISH.)
Description

PersonBreastCarcinomaHormoneReceptorNegativeFindingClinicalTrialEligibilityCriteriaInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C25190
NCI Thesaurus Property
C38757
NCI Thesaurus Property-2
C4872
NCI Thesaurus Property-3
C16112
NCI Thesaurus Property-4
C28154
NCI Thesaurus ValueDomain
C38147
UMLS CUI-1
C2348820
Prior treatments allowed: 0 or 1 prior chemotherapy regimens for breast cancer. <=2 prior aromatase inhibitor regimens (including letrozole)
Description

PriorBreastCarcinomaChemotherapyAdministeredIndicator

Data type

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
The following laboratory values obtained <= 14 days prior to registration
Description

PatientPriorRegistrationLaboratoryProcedureEligibilityDeterminationInd-2

Data type

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.)
Description

LaboratoryProcedureEvaluationPerformedFirstDate

Data type

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 (Note: These dates pertain to the following labs only.)
Description

LaboratoryProcedureEvaluationPerformedMostRecentDate

Data type

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
ANC >= 1,500/mm^3
Description

LaboratoryProcedureAbsoluteNeutrophilCountEligibilityDeterminationInd-2

Data type

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
Description

Neutrophil count

Data type

float

Measurement units
  • 1000/ul
Alias
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus Property
C20200
NCI Thesaurus Property-2
C63321
NCI Thesaurus ValueDomain
C38046
NCI Thesaurus ValueDomain-2
C25712
UMLS CUI [1]
C0200633
1000/ul
Platelet count >= 100,000/mm^3
Description

LaboratoryProcedurePlateletCountEligibilityDeterminationInd-2

Data type

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
Peripheral Platelet Count
Description

Platelets

Data type

float

Measurement units
  • 1000/uL
Alias
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus Property
C20200
NCI Thesaurus Property-2
C12520
NCI Thesaurus ValueDomain
C38046
NCI Thesaurus ValueDomain-2
C25712
UMLS CUI [1]
C0005821
1000/uL
Total bilirubin =< upper limit of normal (ULN)
Description

LaboratoryProcedureWithinClinicalStudyProtocolUpperLimitofNormalTotalBilirubinMeasurementInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus Property
C25320
NCI Thesaurus Property-2
C38037
NCI Thesaurus Property-3
C25282
NCI Thesaurus Property-4
C25706
NCI Thesaurus ValueDomain
C38147
UMLS CUI-1
C0201913
Total Bilirubin
Description

Bilirubin, total

Data type

float

Measurement units
  • mg/dL
Alias
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus Property
C20200
NCI Thesaurus Property-2
C38037
NCI Thesaurus ValueDomain
C38046
NCI Thesaurus ValueDomain-2
C25712
UMLS CUI [1]
C0201913
mg/dL
Total bilirubin ULN
Description

Bilirubin, total ULN

Data type

float

Measurement units
  • mg/dL
Alias
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus Property
C20200
NCI Thesaurus Property-2
C38037
NCI Thesaurus ValueDomain
C25712
NCI Thesaurus ValueDomain-2
C25706
UMLS CUI [1,1]
C0201913
UMLS CUI [1,2]
C1519815
mg/dL
SGPT (ALT) <=3 x ULN or SGPT (ALT) <=5 x ULN if elevations are due to liver metastasis
Description

SerumGlutamicPyruvateTransaminasesHepaticWithinProtocolUpperLimitofNormalLabInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C13308
NCI Thesaurus ObjectClass-2
C25293
NCI Thesaurus Property
C25320
NCI Thesaurus Property-2
C37984
NCI Thesaurus Property-3
C25282
NCI Thesaurus Property-4
C25706
NCI Thesaurus ValueDomain
C38147
UMLS CUI-1
C0201836
Is there liver involvement
Description

LiverInvolvedInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C12392
UMLS 2011AA ObjectClass
C0023884
NCI Thesaurus Property
C25547
SGPT (ALT) (<=5 x ULN if evalations are due to liver metastasis - <=3 x ULN)
Description

LaboratoryProcedureSerumGlutamicPyruvicTransaminaseResultUnspecifiedValue

Data type

float

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
SGPT (ALT) ULN
Description

LaboratoryProcedureSerumGlutamicPyruvicTransaminaseResultUpperLimitofNormalValue

Data type

float

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
C0376147
UMLS CUI-2
C1519815
SGOT (AST) <=3 x ULN or SGOT (AST) <=5 x ULN if elevations are due to liver metastasis
Description

LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseUpperLimitofNormalResultInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus Property
C25202
NCI Thesaurus Property-2
C20200
NCI Thesaurus Property-3
C25706
NCI Thesaurus ValueDomain
C38147
UMLS CUI-1
C0201899
SGOT (AST) (<=5 x ULN if evalations are due to liver metastasis - <=3 x ULN)
Description

LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseResultSpecifiedValue

Data type

float

Measurement units
  • 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
SGOT (AST) ULN
Description

LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseResultUnspecifiedUpperLimitofNormalValue

Data type

float

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
C0242192
UMLS CUI-2
C1519815
TSH <= ULN
Description

LaboratoryProcedureThyroidStimulatingHormoneThyrotropinMeasurementInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus Property
C2280
NCI Thesaurus Property-2
C64813
UMLS CUI-1
C0202230
TSH
Description

Note: Euthyroid patients are permitted to receive thyroid hormone supplements to treat their underlying hypothyroidism, as long as TSH is within normal limits.

Data type

float

Alias
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus Property
C20200
NCI Thesaurus Property-2
C2280
NCI Thesaurus Property-3
C64813
NCI Thesaurus ValueDomain
C38046
NCI Thesaurus ValueDomain-2
C25712
UMLS CUI [1]
C0202230
TSH ULN
Description

LaboratoryProcedureThyroidStimulatingHormoneThyrotropinMeasurementUpperLimitofNormalValue

Data type

float

Alias
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus Property
C2280
NCI Thesaurus Property-2
C64813
NCI Thesaurus ValueDomain
C25712
NCI Thesaurus ValueDomain-2
C25706
UMLS CUI-1
C0202230
UMLS CUI-2
C1519815
Creatinine <= 1.5 x ULN
Description

Creatinine <= 1.5 x ULN

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
NCI Thesaurus Property
C399
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus Property-2
C25171
UMLS CUI [1,1]
C0201976
UMLS CUI [1,2]
C1519815
Creatinine
Description

Creatinine, Serum

Data type

float

Measurement units
  • 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
Creatinine ULN
Description

Creatinine, Serum ULN

Data type

float

Measurement units
  • mg/dL
Alias
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus Property
C20200
NCI Thesaurus Property-2
C399
NCI Thesaurus ValueDomain
C25712
NCI Thesaurus ValueDomain-2
C25706
UMLS CUI [1,1]
C0201976
UMLS CUI [1,2]
C1519815
mg/dL
ECOG performance status (PS) 0, 1, or 2
Description

EasternCooperativeOncologyGroupPerformanceStatusAssessmentInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
NCI Thesaurus Property
C20989
NCI Thesaurus ObjectClass
C25491
NCI Metathesaurus ObjectClass
CL092952
UMLS CUI-1
C1520224
ECOG performance status grade
Description

ECOG

Data type

integer

Alias
NCI Thesaurus ValueDomain
C25664
NCI Thesaurus Property
C25367
NCI Thesaurus ValueDomain-2
C25491
NCI Thesaurus ObjectClass
C20641
UMLS CUI [1]
C1632812
Ability to provide informed written consent
Description

PatientConsentAbilityInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25460
UMLS 2011AA Property
C1511481
NCI Thesaurus Property-2
C78209
UMLS 2011AA Property-2
C0085732
Willing to return to NCCTG enrolling institution for follow-up
Description

PatientTherapeuticProcedureFollow-upEligibilityDeterminationInd-2

Data type

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
Life expectancy >=12 weeks
Description

PatientLifeExpectancyEligibilityDeterminationInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C37987
NCI Thesaurus Property-2
C25171
NCI Thesaurus Property-3
C25359
NCI Thesaurus ValueDomain
C38147
UMLS CUI-1
C0023671
Willing to provide tissue samples for correlative research purposes (see Sections 4.0, 6.25, and 17.1)
Description

PersonSpecimenUseConsentEligibilityDeterminationIndicator

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C25190
NCI Thesaurus Property
C19157
NCI Thesaurus Property-2
C25171
NCI Thesaurus Property-3
C25460
NCI Thesaurus Property-4
C25340
NCI Thesaurus ValueDomain
C25180
UMLS CUI-1
C0006826
UMLS CUI-2
C0370003
UMLS CUI-3
C1511481
Exclusion Criteria - All Responses In Section Below Must Be "no."
Description

Exclusion Criteria - All Responses In Section Below Must Be "no."

Alias
UMLS CUI-1
C0680251
Known standard therapy for the patient's disease that is potentially curative or definitely capable of extending life expectancy
Description

PersonStandardTreatmentRegimenOptionsExclusionCriteriaInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C15697
UMLS 2011AA Property
C0040808
NCI Thesaurus Property-2
C44275
UMLS 2011AA Property-2
C1442989
NCI Thesaurus Property-3
C25370
UMLS 2011AA Property-3
C0680251
NCI Thesaurus Property-4
C25374
UMLS 2011AA Property-4
C1518601
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
>1prior chemotherapy regimen for breast cancer. >2 prior aromatase inhibitor regimens
Description

PersonPriorTherapeuticProcedureClinicalTrialEligibilityCriteriaInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C25629
UMLS 2011AA Property
C0332152
NCI Thesaurus Property-2
C49236
UMLS 2011AA Property-2
C0087111
NCI Thesaurus Property-3
C16112
UMLS 2011AA Property-3
C1516637
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Description

PatientUncontrolledConcurrentDiseaseorDisorderExclusionCriteriaInd-2

Data type

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
Chemotherapy <=4 weeks prior to registration (Any of the following prior therapies: If no prior chemotherapy check NA)
Description

PersonPriorChemotherapyExclusionCriteriaInd-3b

Data type

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C15632
UMLS 2011AA Property
C0392920
NCI Thesaurus Property-2
C25629
UMLS 2011AA Property-2
C0332152
NCI Thesaurus Property-3
C25370
UMLS 2011AA Property-3
C0680251
NCI Thesaurus ValueDomain
C49797
UMLS 2011AA ValueDomain
C1708496
Last day of chemotherapy (If prior chemotherapy)
Description

ChemotherapyLastAdministeredDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C15632
UMLS 2011AA ObjectClass
C0392920
NCI Thesaurus Property
C25551
UMLS 2011AA Property
C1517741
NCI Thesaurus Property-2
C25382
UMLS 2011AA Property-2
C1521801
Radiation therapy <=4 weeks prior to registration (If no prior radiation therapy check NA)
Description

PatientRadiationTherapyPriorRegistrationExclusionCriteriaInd-3b

Data type

text

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
C49797
UMLS 2011AA ValueDomain
C1708496
Last day of radiation therapy (If prior radiation therapy)
Description

PriorRadiationTherapyAdministeredEndDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C15313
UMLS 2011AA ObjectClass
C1522449
NCI Thesaurus ObjectClass-2
C25629
UMLS 2011AA ObjectClass-2
C0332152
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Radiation to >25% of bone marrow
Description

RadiationTherapyBoneMarrowAdministeredInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C15313
UMLS 2011AA ObjectClass
C1522449
NCI Thesaurus Property
C12431
UMLS 2011AA Property
C0005953
NCI Thesaurus Property-2
C25382
UMLS 2011AA Property-2
C1521801
Failure to fully recover from acute, reversible effects of prior chemotherapy regardless of interval since last treatment
Description

PersonFailureRecoveredorResolvedPriorTreatmentRegimenExclusionCriteriaInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C25190
NCI Thesaurus Property
C25629
NCI Thesaurus Property-2
C25745
NCI Thesaurus Property-3
C49498
NCI Thesaurus Property-4
C15697
NCI Thesaurus Property-5
C25370
NCI Thesaurus ValueDomain
C38147
New York Heart Association class III or IV cardiovascular disease
Description

PatientNewYorkHeartAssociationClassIII/IVEligibilityDeterminationInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25171
NCI Thesaurus Property-2
C7922
UMLS CUI-1
C1275491
Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and 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)
Description

PatientContraceptionEligibilityDeterminationInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C37932
UMLS 2011AA Property
C0700589
NCI Thesaurus Property-2
C25171
UMLS 2011AA Property-2
C0013893
Receiving any other investigational agent concurrently which would be considered as a treatment for the primary neoplasm
Description

PatientInvestigationalClinicalTrialCurrentParticipationExclusionCriteriaInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25608
NCI Thesaurus Property-2
C25471
NCI Thesaurus Property-3
C15207
NCI Thesaurus Property-4
C28041
NCI Thesaurus Property-5
C25370
NCI Thesaurus ValueDomain
C38147
UMLS CUI-1
C2348568
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 safety and toxicity of the prescribed regimens
Description

PatientConcurrentSystemicDiseaseorDisorderExclusionCriteriaInd-2

Data type

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
Immunocompromised patients (other than that related to the use of corticosteroids) including patients known to be HIV positive
Description

PatientImmunocompromisedExclusionCriteriaind-2

Data type

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
History of other malignancy <=5 years with the exception of non-melanoma skin cancer or carcinoma in-situ of the cervix
Description

PatientNeoplasmPersonalMedicalHistoryInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C3262
UMLS 2011AA Property
C0027651
NCI Thesaurus Property-2
C18772
UMLS 2011AA Property-2
C0262926
History of myocardial infarction or unstable angina <=6 months prior to registration or congestive heart failure (CHF) requiring use of ongoing maintenance therapy, or life-threatening ventricular arrhythmias
Description

SymptomaticChronicHeartDiseasePresentInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus ObjectClass
C25269
UMLS 2011AA ObjectClass
C0231220
NCI Metathesaurus ObjectClass
CL299150
Receiving CYP3A4 inhibitors and inducers or any other contraindicated agent listed in Appendix III
Description

PatientContraindicatedAgentExclusionCriteriaInd-2

Data type

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
Congenital long QT syndrome or QTcF>450 msec on screening ECG:- Complete left bundle block or use of a permanent cardiac pacemaker, history or presence of ventricular tachyarrhythmias, clinically significant resting bradycardia (<50 beats per minute)- Right bundle branch block + left anterior hemiblock (bifascicular block
Description

PatientCongenitalAbnormalityLongQTIntervalExclusionCriteriaInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C2849
NCI Thesaurus Property-2
C25248
NCI Thesaurus Property-3
C83501
NCI Thesaurus Property-4
C16148
NCI Thesaurus ValueDomain
C38147
UMLS CUI-1
C0023976
Registration Check
Description

Registration Check

Consent form signed and dated
Description

InformedConsentFormSignedInd-2

Data type

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
Description

InformedConsentFormSignedDate

Data type

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)
Description

PatientHealthRecordIndicator

Data type

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
Description

PatientSignedDischargeMedicalRecordDate

Data type

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 correlative research component is part of this study for all patients, the patient will be automatically registered onto this component (see Section 3.19c, 4.0 and/or 17.1)
Description

PatientRegisteredInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25644
Treatment on this protocol must commence at the accruing membership under the supervision of an NCCTG member physician
Description

ManagementNorthCentralCancerTreatmentGroupTherapyInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C25581
UMLS 2011AA ObjectClass
C1518419
NCI Thesaurus Property
C15368
NCI Thesaurus ObjectClass-2
C61372
UMLS 2011AA ObjectClass-2
C1273870
Treatment cannot begin prior to registration and must begin <=14 days after registration
Description

ClinicalTrialTherapeuticProcedurePostRegistrationChecklistInd-2

Data type

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 <= 14 days prior to registration (see Section 4.0 - 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.)
Description

PatientPriorRegistrationLaboratoryProcedureVerificationInd-2

Data type

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
Description

PatientPriorRegistrationLaboratoryProcedureEligibilityDeterminationBeginDate

Data type

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
Description

PatientPriorRegistrationLaboratoryProcedureEligibilityDeterminationEndDate

Data type

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
All required baseline symptoms (see Section 10.3) must be documented and graded
Description

ClinicalTrialBaselineDiseaseDocumentedChecklistInd-2

Data type

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
Description

ClinicalTrialProtocolAgentAvailabilityChecklistInd-2

Data type

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 (Blood kit must be available on site)
Description

ClinicalTrialBloodSpecimenCollectionAvailabilityChecklistInd-2

Data type

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
Patient has given permission to give his/her blood sample for research testing
Description

PatientCorrelativeStudySpecimenConsentInd-3

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C19157
UMLS 2011AA Property
C0370003
NCI Thesaurus Property-2
C25460
UMLS 2011AA Property-2
C1511481
NCI Thesaurus Property-3
C16100
UMLS 2011AA Property-3
C1511524
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Patient has given permission to store and use his/her blood/plasma sample for future research to learn about, prevent, or treat cancer
Description

BloodSpecimenMalignantNeoplasmRelatedResearchConsentInd-3

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C12434
UMLS 2011AA ObjectClass
C0229664
NCI Thesaurus ObjectClass-2
C19157
UMLS 2011AA ObjectClass-2
C0370003
NCI Thesaurus Property
C15319
NCI Thesaurus Property-2
C25648
UMLS 2011AA Property
C0439849
NCI Thesaurus Property-3
C9305
UMLS 2011AA Property-2
C0006826
NCI Thesaurus Property-4
C25460
UMLS 2011AA Property-3
C1511481
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Patient has given permission to store and use his/her blood/plasma sample for use in future research to learn about, prevent, or treat other health problems (for example: diabetes, Alzheimer's disease, or heart disease)
Description

BloodSpecimenOtherDiseasesandDisordersResearchConsentInd-3

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C12434
UMLS 2011AA ObjectClass
C0229664
NCI Thesaurus ObjectClass-2
C19157
UMLS 2011AA ObjectClass-2
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 blood to outside researchers
Description

PersonSpecimenExternalInvestigatorBloodSampleConsentInd-2

Data type

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 Property-5
C17610
UMLS 2011AA Property-5
C0178913
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Patient has given permission to store and use his/her sample(s) for use in future research to learn about, prevent, or treat cancer
Description

PersonSpecimenMalignantNeoplasmFutureClinicalorResearchActivityConsentInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C25190
NCI Thesaurus Property
C67527
NCI Thesaurus Property-2
C9305
NCI Thesaurus Property-3
C19157
NCI Thesaurus Property-4
C25460
NCI Thesaurus Property-5
C16203
NCI Thesaurus ValueDomain
C38147
UMLS CUI-1
C0006826
UMLS CUI-2
C0370003
UMLS CUI-3
C1511481
Patient has given permission to store and use his/her tissue(s) sample for use in future research to learn about, prevent, or treat other health problems (for example: diabetes, Alzheimer's disease, or heart disease)
Description

TissueSpecimenResearchConsentUnrelatedInd-3

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C12801
UMLS 2011AA ObjectClass
C0040300
NCI Thesaurus ObjectClass-2
C19157
UMLS 2011AA ObjectClass-2
C0370003
NCI Thesaurus Property
C15319
NCI Thesaurus Property-2
C25460
UMLS 2011AA Property
C1511481
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ValueDomain-2
C25328
UMLS 2011AA ValueDomain-2
C0445356
Patient has given NCCTG permission to give tissue(s) to outside researchers
Description

PersonSpecimenExternalInvestigatorTissueSampleConsentInd-2

Data type

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
C19697
UMLS 2011AA Property-4
C1292533
NCI Thesaurus Property-5
C25460
UMLS 2011AA Property-5
C1511481
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Is this an NCCTG institution (NCCTG Institutions only: N0932 must be open at site and offered to patient. - This question may be answered yes or no.)
Description

NorthCentralCancerTreatmentGroupHealthcareFacilityInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C21541
UMLS 2011AA Property
C0018704
NCI Thesaurus ObjectClass
C25581
UMLS 2011AA ObjectClass
C1518419
Patient has agreed to be enrolled on N0932 (At time of registration, the following will be recorded:)
Description

PatientNorthCentralCancerTreatmentGroupEnrollmentInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25581
UMLS 2011AA Property
C1518419
NCI Thesaurus Property-2
C37948
UMLS 2011AA Property-2
C1516879
Grouping Factor (Patient Cohort)
Description

PhaseGroupingFactorType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C25257
UMLS 2011AA ObjectClass
C0205390
NCI Thesaurus Property
C61039
UMLS 2011AA Property
C1881010
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  1. StudyEvent: NCCTG Eligibility Checklist N093B
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Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Pre-treatment Requirements
Patient Age
Item
Age >= 18 years
boolean
C38147 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C25150 (NCI Thesaurus Property)
C0001779 (UMLS CUI [1])
Patient Age Year Count
Item
Age
integer
C16960 (NCI Thesaurus ObjectClass)
C29848 (NCI Thesaurus ValueDomain)
C25463 (NCI Thesaurus ValueDomain-2)
C25150 (NCI Thesaurus Property)
C0001779 (UMLS CUI-1)
Metastatic breast cancer
Item
Histologic proof of metastatic breast cancer that is unresected at registration (with no intention of resecting tumors during this study). Evidence of metastatic breast cancer confirmed by radiological imaging
boolean
C25190 (NCI Thesaurus ObjectClass)
C14174 (NCI Thesaurus Property)
C4872 (NCI Thesaurus Property-2)
CL008804 (NCI Metathesaurus Property)
C94255 (NCI Thesaurus Property-3)
C38147 (NCI Thesaurus ValueDomain)
C0036525 (UMLS CUI-1)
C0678222 (UMLS CUI-2)
MeasurableDiseasePresentInd-3
Item
Measurable disease (see Section 11.21 for definition of measurable disease)
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C37894 (NCI Thesaurus ObjectClass-2)
C1513040 (UMLS 2011AA ObjectClass-2)
PersonMetastasisPossibleBiopsyClinicalTrialEligibilityCriteriaInd-2
Item
Metastatic site(s) must be amenable to biopsy
boolean
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C15189 (NCI Thesaurus Property)
C0005558 (UMLS 2011AA Property)
C19151 (NCI Thesaurus Property-2)
C0027627 (UMLS 2011AA Property-2)
C16112 (NCI Thesaurus Property-3)
C1516637 (UMLS 2011AA Property-3)
C82490 (NCI Thesaurus Property-4)
C0332149 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Item
Post-menopausal according to any one of the following criteria: a. Age >60 years old b. Age >45 years old with last menstrual period >12 months prior to registration and estriadiol and folliclestimulating hormone (FSH) levels in postmenopausal range (per institutional normal limits) c. Bilateral oophorectomy If male (check NA).
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C15421 (NCI Thesaurus Property)
C0232970 (UMLS 2011AA Property)
CL.5
Code List
Post-menopausal according to any one of the following criteria: a. Age >60 years old b. Age >45 years old with last menstrual period >12 months prior to registration and estriadiol and folliclestimulating hormone (FSH) levels in postmenopausal range (per institutional normal limits) c. Bilateral oophorectomy If male (check NA).
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Not Available (NA)
Triple negative breast carcinoma
Item
Tumor estrogen, progesterone and HER2 [tested by IHC or FISH (fluorescent in situ hybridization)] status from the metastatic site. If not available, the results from the original tumor diagnosing the primary breast cancer may be used.- Triple negative disease only [ER- (defined as =<1% by IHC), PR- (defined as =<1% by IHC), and HER2-] Patients with triple negative breast cancer are allowed if there is clinical or radiographic evidence of tumor progression in the adjuvant or metastatic setting. (Note: If HER2 result by IHC is 2+ equivocal, the tumor must be confirmed to be HER2- by FISH.)
boolean
C25190 (NCI Thesaurus ObjectClass)
C38757 (NCI Thesaurus Property)
C4872 (NCI Thesaurus Property-2)
C16112 (NCI Thesaurus Property-3)
C28154 (NCI Thesaurus Property-4)
C38147 (NCI Thesaurus ValueDomain)
C2348820 (UMLS CUI-1)
PriorBreastCarcinomaChemotherapyAdministeredIndicator
Item
Prior treatments allowed: 0 or 1 prior chemotherapy regimens for breast cancer. <=2 prior aromatase inhibitor regimens (including letrozole)
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)
PatientPriorRegistrationLaboratoryProcedureEligibilityDeterminationInd-2
Item
The following laboratory values obtained <= 14 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 (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)
C25577 (NCI Thesaurus ValueDomain-2)
C1513491 (UMLS 2011AA ValueDomain-2)
LaboratoryProcedureAbsoluteNeutrophilCountEligibilityDeterminationInd-2
Item
ANC >= 1,500/mm^3
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)
Neutrophil count
Item
ANC
float
C25294 (NCI Thesaurus ObjectClass)
C20200 (NCI Thesaurus Property)
C63321 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C0200633 (UMLS CUI [1])
LaboratoryProcedurePlateletCountEligibilityDeterminationInd-2
Item
Platelet count >= 100,000/mm^3
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
Peripheral Platelet Count
float
C25294 (NCI Thesaurus ObjectClass)
C20200 (NCI Thesaurus Property)
C12520 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C0005821 (UMLS CUI [1])
Total bilirubin
Item
Total bilirubin =< upper limit of normal (ULN)
boolean
C25294 (NCI Thesaurus ObjectClass)
C25320 (NCI Thesaurus Property)
C38037 (NCI Thesaurus Property-2)
C25282 (NCI Thesaurus Property-3)
C25706 (NCI Thesaurus Property-4)
C38147 (NCI Thesaurus ValueDomain)
C0201913 (UMLS CUI-1)
Bilirubin, total
Item
Total Bilirubin
float
C25294 (NCI Thesaurus ObjectClass)
C20200 (NCI Thesaurus Property)
C38037 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C0201913 (UMLS CUI [1])
Bilirubin, total ULN
Item
Total bilirubin ULN
float
C25294 (NCI Thesaurus ObjectClass)
C20200 (NCI Thesaurus Property)
C38037 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C0201913 (UMLS CUI [1,1])
C1519815 (UMLS CUI [1,2])
SGPT
Item
SGPT (ALT) <=3 x ULN or SGPT (ALT) <=5 x ULN if elevations are due to liver metastasis
boolean
C13308 (NCI Thesaurus ObjectClass)
C25293 (NCI Thesaurus ObjectClass-2)
C25320 (NCI Thesaurus Property)
C37984 (NCI Thesaurus Property-2)
C25282 (NCI Thesaurus Property-3)
C25706 (NCI Thesaurus Property-4)
C38147 (NCI Thesaurus ValueDomain)
C0201836 (UMLS CUI-1)
LiverInvolvedInd-3
Item
Is there liver involvement
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C12392 (NCI Thesaurus ObjectClass)
C0023884 (UMLS 2011AA ObjectClass)
C25547 (NCI Thesaurus Property)
SGPT
Item
SGPT (ALT) (<=5 x ULN if evalations are due to liver metastasis - <=3 x ULN)
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)
SGPT ULN
Item
SGPT (ALT) 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)
C1519815 (UMLS CUI-2)
SGOT
Item
SGOT (AST) <=3 x ULN or SGOT (AST) <=5 x ULN if elevations are due to liver metastasis
boolean
C25294 (NCI Thesaurus ObjectClass)
C25202 (NCI Thesaurus Property)
C20200 (NCI Thesaurus Property-2)
C25706 (NCI Thesaurus Property-3)
C38147 (NCI Thesaurus ValueDomain)
C0201899 (UMLS CUI-1)
SGOT
Item
SGOT (AST) (<=5 x ULN if evalations are due to liver metastasis - <=3 x ULN)
float
C25202 (NCI Thesaurus Property)
C20200 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C0201899 (UMLS CUI-1)
SGOT ULN
Item
SGOT (AST) 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)
C1519815 (UMLS CUI-2)
TSH
Item
TSH <= ULN
boolean
C38147 (NCI Thesaurus ValueDomain)
C25294 (NCI Thesaurus ObjectClass)
C2280 (NCI Thesaurus Property)
C64813 (NCI Thesaurus Property-2)
C0202230 (UMLS CUI-1)
TSH
Item
TSH
float
C25294 (NCI Thesaurus ObjectClass)
C20200 (NCI Thesaurus Property)
C2280 (NCI Thesaurus Property-2)
C64813 (NCI Thesaurus Property-3)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C0202230 (UMLS CUI [1])
TSH ULN
Item
TSH ULN
float
C25294 (NCI Thesaurus ObjectClass)
C2280 (NCI Thesaurus Property)
C64813 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C0202230 (UMLS CUI-1)
C1519815 (UMLS CUI-2)
Creatinine <= 1.5 x ULN
Item
Creatinine <= 1.5 x ULN
boolean
C38147 (NCI Thesaurus ValueDomain)
C399 (NCI Thesaurus Property)
C25294 (NCI Thesaurus ObjectClass)
C25171 (NCI Thesaurus Property-2)
C0201976 (UMLS CUI [1,1])
C1519815 (UMLS CUI [1,2])
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
Creatinine ULN
float
C25294 (NCI Thesaurus ObjectClass)
C20200 (NCI Thesaurus Property)
C399 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C0201976 (UMLS CUI [1,1])
C1519815 (UMLS CUI [1,2])
ECOG
Item
ECOG performance status (PS) 0, 1, or 2
boolean
C38147 (NCI Thesaurus ValueDomain)
C20989 (NCI Thesaurus Property)
C25491 (NCI Thesaurus ObjectClass)
CL092952 (NCI Metathesaurus ObjectClass)
C1520224 (UMLS CUI-1)
Item
ECOG performance status grade
integer
C25664 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus Property)
C25491 (NCI Thesaurus ValueDomain-2)
C20641 (NCI Thesaurus ObjectClass)
C1632812 (UMLS CUI [1])
CL.19
Code List
ECOG performance status grade
CL Item
Fully Active, Able To Carry On All Pre-disease Performance Without Restriction. (0) (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) (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) (2)
CL Item
Capable Of Only Limited Selfcare, Confined To Bed Or Chair More Than 50% Of Waking Hours. (3) (3)
CL Item
Completely Disabled. Cannot Carry On Any Selfcare. Totally Confined To Bed Or Chair. (4) (4)
CL Item
Dead (5) (5)
PatientConsentAbilityInd-2
Item
Ability to provide informed written consent
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25460 (NCI Thesaurus Property)
C1511481 (UMLS 2011AA Property)
C78209 (NCI Thesaurus Property-2)
C0085732 (UMLS 2011AA Property-2)
PatientTherapeuticProcedureFollow-upEligibilityDeterminationInd-2
Item
Willing to return to NCCTG enrolling institution for 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)
Life expectancy
Item
Life expectancy >=12 weeks
boolean
C16960 (NCI Thesaurus ObjectClass)
C37987 (NCI Thesaurus Property)
C25171 (NCI Thesaurus Property-2)
C25359 (NCI Thesaurus Property-3)
C38147 (NCI Thesaurus ValueDomain)
C0023671 (UMLS CUI-1)
Research use of specimen permitted
Item
Willing to provide tissue samples for correlative research purposes (see Sections 4.0, 6.25, and 17.1)
boolean
C25190 (NCI Thesaurus ObjectClass)
C19157 (NCI Thesaurus Property)
C25171 (NCI Thesaurus Property-2)
C25460 (NCI Thesaurus Property-3)
C25340 (NCI Thesaurus Property-4)
C25180 (NCI Thesaurus ValueDomain)
C0006826 (UMLS CUI-1)
C0370003 (UMLS CUI-2)
C1511481 (UMLS CUI-3)
Item Group
Exclusion Criteria - All Responses In Section Below Must Be "no."
C0680251 (UMLS CUI-1)
PersonStandardTreatmentRegimenOptionsExclusionCriteriaInd-2
Item
Known standard therapy for the patient's disease that is potentially curative or definitely capable of extending life expectancy
boolean
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C15697 (NCI Thesaurus Property)
C0040808 (UMLS 2011AA Property)
C44275 (NCI Thesaurus Property-2)
C1442989 (UMLS 2011AA Property-2)
C25370 (NCI Thesaurus Property-3)
C0680251 (UMLS 2011AA Property-3)
C25374 (NCI Thesaurus Property-4)
C1518601 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PersonPriorTherapeuticProcedureClinicalTrialEligibilityCriteriaInd-2
Item
>1prior chemotherapy regimen for breast cancer. >2 prior aromatase inhibitor regimens
boolean
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C49236 (NCI Thesaurus Property-2)
C0087111 (UMLS 2011AA Property-2)
C16112 (NCI Thesaurus Property-3)
C1516637 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PatientUncontrolledConcurrentDiseaseorDisorderExclusionCriteriaInd-2
Item
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or 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)
Item
Chemotherapy <=4 weeks prior to registration (Any of the following prior therapies: If no prior chemotherapy check NA)
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C15632 (NCI Thesaurus Property)
C0392920 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property-2)
C0332152 (UMLS 2011AA Property-2)
C25370 (NCI Thesaurus Property-3)
C0680251 (UMLS 2011AA Property-3)
C49797 (NCI Thesaurus ValueDomain)
C1708496 (UMLS 2011AA ValueDomain)
CL.27
Code List
Chemotherapy <=4 weeks prior to registration (Any of the following prior therapies: If no prior chemotherapy check NA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Not Applicable (NA)
C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)
ChemotherapyLastAdministeredDate
Item
Last day of chemotherapy (If prior chemotherapy)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C25551 (NCI Thesaurus Property)
C1517741 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
Item
Radiation therapy <=4 weeks prior to registration (If no prior radiation therapy check NA)
text
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)
C49797 (NCI Thesaurus ValueDomain)
C1708496 (UMLS 2011AA ValueDomain)
CL.28
Code List
Radiation therapy <=4 weeks prior to registration (If no prior radiation therapy check NA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Not Applicable (NA)
C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)
PriorRadiationTherapyAdministeredEndDate
Item
Last day of radiation therapy (If prior radiation therapy)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
RadiationTherapyBoneMarrowAdministeredInd-2
Item
Radiation to >25% of bone marrow
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C12431 (NCI Thesaurus Property)
C0005953 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
No full recovery from chemotherapy
Item
Failure to fully recover from acute, reversible effects of prior chemotherapy regardless of interval since last treatment
boolean
C25190 (NCI Thesaurus ObjectClass)
C25629 (NCI Thesaurus Property)
C25745 (NCI Thesaurus Property-2)
C49498 (NCI Thesaurus Property-3)
C15697 (NCI Thesaurus Property-4)
C25370 (NCI Thesaurus Property-5)
C38147 (NCI Thesaurus ValueDomain)
NYHA
Item
New York Heart Association class III or IV cardiovascular disease
boolean
C38147 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C25171 (NCI Thesaurus Property)
C7922 (NCI Thesaurus Property-2)
C1275491 (UMLS CUI-1)
PatientContraceptionEligibilityDeterminationInd-2
Item
Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and 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
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C37932 (NCI Thesaurus Property)
C0700589 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property-2)
C0013893 (UMLS 2011AA Property-2)
Other trial
Item
Receiving any other investigational agent concurrently which would be considered as a treatment for the primary neoplasm
boolean
C16960 (NCI Thesaurus ObjectClass)
C25608 (NCI Thesaurus Property)
C25471 (NCI Thesaurus Property-2)
C15207 (NCI Thesaurus Property-3)
C28041 (NCI Thesaurus Property-4)
C25370 (NCI Thesaurus Property-5)
C38147 (NCI Thesaurus ValueDomain)
C2348568 (UMLS CUI-1)
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 safety and toxicity 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)
PatientImmunocompromisedExclusionCriteriaind-2
Item
Immunocompromised patients (other than that related to the use of corticosteroids) including patients known to be HIV positive
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)
PatientNeoplasmPersonalMedicalHistoryInd-2
Item
History of other malignancy <=5 years with the exception of non-melanoma skin cancer or carcinoma in-situ of the cervix
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C3262 (NCI Thesaurus Property)
C0027651 (UMLS 2011AA Property)
C18772 (NCI Thesaurus Property-2)
C0262926 (UMLS 2011AA Property-2)
SymptomaticChronicHeartDiseasePresentInd-2
Item
History of myocardial infarction or unstable angina <=6 months prior to registration or congestive heart failure (CHF) requiring use of ongoing maintenance therapy, or life-threatening ventricular arrhythmias
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C25269 (NCI Thesaurus ObjectClass)
C0231220 (UMLS 2011AA ObjectClass)
CL299150 (NCI Metathesaurus ObjectClass)
PatientContraindicatedAgentExclusionCriteriaInd-2
Item
Receiving CYP3A4 inhibitors and inducers or any other contraindicated agent listed in Appendix III
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)
Long QT syndrome
Item
Congenital long QT syndrome or QTcF>450 msec on screening ECG:- Complete left bundle block or use of a permanent cardiac pacemaker, history or presence of ventricular tachyarrhythmias, clinically significant resting bradycardia (<50 beats per minute)- Right bundle branch block + left anterior hemiblock (bifascicular block
boolean
C16960 (NCI Thesaurus ObjectClass)
C2849 (NCI Thesaurus Property)
C25248 (NCI Thesaurus Property-2)
C83501 (NCI Thesaurus Property-3)
C16148 (NCI Thesaurus Property-4)
C38147 (NCI Thesaurus ValueDomain)
C0023976 (UMLS CUI-1)
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.42
Code List
Authorization for use and disclosure of protected health information signed and dated (Non-USA institution only check NA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Not Applicable (NA)
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 correlative research component is part of this study for all patients, the patient will be automatically registered onto this component (see Section 3.19c, 4.0 and/or 17.1)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25644 (NCI Thesaurus Property)
ManagementNorthCentralCancerTreatmentGroupTherapyInd-2
Item
Treatment on this protocol must commence at the accruing membership under the supervision of an NCCTG member physician
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25581 (NCI Thesaurus ObjectClass)
C1518419 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus Property)
C61372 (NCI Thesaurus ObjectClass-2)
C1273870 (UMLS 2011AA ObjectClass-2)
ClinicalTrialTherapeuticProcedurePostRegistrationChecklistInd-2
Item
Treatment cannot begin prior to registration and must begin <=14 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 <= 14 days prior to registration (see Section 4.0 - 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)
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
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 (Blood kit must be available on site)
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)
PatientCorrelativeStudySpecimenConsentInd-3
Item
Patient has given permission to give his/her blood sample for research testing
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus Property)
C0370003 (UMLS 2011AA Property)
C25460 (NCI Thesaurus Property-2)
C1511481 (UMLS 2011AA Property-2)
C16100 (NCI Thesaurus Property-3)
C1511524 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
BloodSpecimenMalignantNeoplasmRelatedResearchConsentInd-3
Item
Patient has given permission to store and use his/her blood/plasma sample for future research to learn about, prevent, or treat cancer
boolean
C12434 (NCI Thesaurus ObjectClass)
C0229664 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass-2)
C0370003 (UMLS 2011AA ObjectClass-2)
C15319 (NCI Thesaurus Property)
C25648 (NCI Thesaurus Property-2)
C0439849 (UMLS 2011AA Property)
C9305 (NCI Thesaurus Property-3)
C0006826 (UMLS 2011AA Property-2)
C25460 (NCI Thesaurus Property-4)
C1511481 (UMLS 2011AA Property-3)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
BloodSpecimenOtherDiseasesandDisordersResearchConsentInd-3
Item
Patient has given permission to store and use his/her blood/plasma sample for use in future research to learn about, prevent, or treat other health problems (for example: diabetes, Alzheimer's disease, or heart disease)
boolean
C12434 (NCI Thesaurus ObjectClass)
C0229664 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass-2)
C0370003 (UMLS 2011AA ObjectClass-2)
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)
PersonSpecimenExternalInvestigatorBloodSampleConsentInd-2
Item
Patient has given NCCTG permission to give blood 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)
C17610 (NCI Thesaurus Property-5)
C0178913 (UMLS 2011AA Property-5)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Research use of specimen permitted
Item
Patient has given permission to store and use his/her sample(s) for use in future research to learn about, prevent, or treat cancer
boolean
C25190 (NCI Thesaurus ObjectClass)
C67527 (NCI Thesaurus Property)
C9305 (NCI Thesaurus Property-2)
C19157 (NCI Thesaurus Property-3)
C25460 (NCI Thesaurus Property-4)
C16203 (NCI Thesaurus Property-5)
C38147 (NCI Thesaurus ValueDomain)
C0006826 (UMLS CUI-1)
C0370003 (UMLS CUI-2)
C1511481 (UMLS CUI-3)
TissueSpecimenResearchConsentUnrelatedInd-3
Item
Patient has given permission to store and use his/her tissue(s) sample 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)
C19157 (NCI Thesaurus ObjectClass-2)
C0370003 (UMLS 2011AA ObjectClass-2)
C15319 (NCI Thesaurus Property)
C25460 (NCI Thesaurus Property-2)
C1511481 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25328 (NCI Thesaurus ValueDomain-2)
C0445356 (UMLS 2011AA ValueDomain-2)
PersonSpecimenExternalInvestigatorTissueSampleConsentInd-2
Item
Patient has given NCCTG permission to give tissue(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)
C19697 (NCI Thesaurus Property-4)
C1292533 (UMLS 2011AA Property-4)
C25460 (NCI Thesaurus Property-5)
C1511481 (UMLS 2011AA Property-5)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
NorthCentralCancerTreatmentGroupHealthcareFacilityInd-2
Item
Is this an NCCTG institution (NCCTG Institutions only: N0932 must be open at site and offered to patient. - This question may be answered yes or no.)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C21541 (NCI Thesaurus Property)
C0018704 (UMLS 2011AA Property)
C25581 (NCI Thesaurus ObjectClass)
C1518419 (UMLS 2011AA ObjectClass)
PatientNorthCentralCancerTreatmentGroupEnrollmentInd-2
Item
Patient has agreed to be enrolled on N0932 (At time of registration, the following will be recorded:)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25581 (NCI Thesaurus Property)
C1518419 (UMLS 2011AA Property)
C37948 (NCI Thesaurus Property-2)
C1516879 (UMLS 2011AA Property-2)
Item
Grouping Factor (Patient Cohort)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25257 (NCI Thesaurus ObjectClass)
C0205390 (UMLS 2011AA ObjectClass)
C61039 (NCI Thesaurus Property)
C1881010 (UMLS 2011AA Property)
CL.59
Code List
Grouping Factor (Patient Cohort)
CL Item
Phase Ii (Phase II)
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