ID

42992

Description

ACOSOG-Z1031 OPEN Registration Worksheet Exemestane, Letrozole, or Anastrozole in Treating Postmenopausal Women Who Are Undergoing Surgery for Stage II or Stage III Breast Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=8036B060-D675-EB4B-E040-BB89AD434531

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=8036B060-D675-EB4B-E040-BB89AD434531

Keywords

Versions (4)
  1. 9/19/12 9/19/12 -
  2. 1/9/15 1/9/15 - Martin Dugas
  3. 1/9/15 1/9/15 - Martin Dugas
  4. 9/17/21 9/17/21 -
Uploaded on

September 17, 2021

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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Endometrial Cancer NCT00265759 Registration - ACOSOG-Z1031 OPEN Registration Worksheet - 3014513v1.0

English

No Instruction available.

1 forms  
  1. StudyEvent: ACOSOG-Z1031 OPEN Registration Worksheet
    1. No Instruction available.
Header Module
Description

Header Module

Institution CTEP ID
Description

TreatingInstitutionTextCode

Data type

text

Alias
NCI Thesaurus ValueDomain
C25162
UMLS 2011AA ValueDomain
C0805701
NCI Thesaurus ObjectClass
C25705
UMLS 2011AA ObjectClass
C1522326
NCI Thesaurus ObjectClass-2
C19992
UMLS 2011AA ObjectClass-2
C1516607
NCI Metathesaurus Property
CL281747
Institution Name
Description

Institution Name

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C1301943
NCI Thesaurus ObjectClass
C21541
NCI Thesaurus ValueDomain-2
C21541
NCI Thesaurus Property
C25364
Protocol Number
Description

Protocol ID ACOSOG

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C1515944
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C19712
Protocol Title
Description

Protocol Title

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986303
NCI Thesaurus ObjectClass
C25320
NCI Thesaurus Property
C42774
Registration Step
Description

Registration Number

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C1514821
NCI Thesaurus ObjectClass
C25646
UMLS CUI-2
C0237753
NCI Thesaurus Property
C16154
NCI Thesaurus ValueDomain-2
C16154
Treating Investigator
Description

TreatingPhysicianOrParticipatingInvestigatorName

Data type

text

Alias
NCI Thesaurus ObjectClass
C25608
UMLS 2011AA ObjectClass
C0679823
NCI Thesaurus ObjectClass-2
C37998
UMLS 2011AA ObjectClass-2
C1518602
NCI Thesaurus ObjectClass-3
C51883
UMLS 2011AA ObjectClass-3
C1710470
NCI Thesaurus ObjectClass-4
C25936
UMLS 2011AA ObjectClass-4
C0035173
NCI Thesaurus Property
C25191
UMLS 2011AA Property
C1547383
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
Site Registrar
Description

Protocol Registrar

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C1507394
NCI Thesaurus Property
C25364
UMLS CUI-2
C0557514
NCI Thesaurus ObjectClass
C25357
Cooperative Group (Credit)
Description

ClinicalTrialsCooperativeGroupRegisteringInstitutionIdentifierCode

Data type

text

Alias
NCI Thesaurus ObjectClass
C41206
UMLS 2011AA ObjectClass
C1272753
NCI Thesaurus ObjectClass-2
C25645
NCI Thesaurus ObjectClass-3
C18205
UMLS 2011AA ObjectClass-2
C1521808
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ValueDomain
C25162
UMLS 2011AA ValueDomain
C0805701
Investigator (Credit)
Description

InvestigatorName

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ObjectClass
C17089
UMLS 2011AA ObjectClass
C0035173
Comments (Enter case notes optional)
Description

Research Comments

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0947611
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
Patient Information
Description

Patient Information

Date of Birth (month day year)
Description

PersonBirthDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C25155
UMLS 2011AA Property
C0005615
Gender of a Person
Description

PersonGenderTextType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C17357
UMLS 2011AA Property
C0079399
Ethnicity
Description

EthnicGroupCategoryText

Data type

text

Alias
NCI Thesaurus Property
C25372
UMLS 2011AA Property
C0683312
NCI Thesaurus ValueDomain
C25372
UMLS 2011AA ValueDomain
C0683312
NCI Thesaurus ObjectClass
C16564
UMLS 2011AA ObjectClass
C0015031
Country of Residence
Description

PersonAddressCountryName

Data type

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus ValueDomain
C25464
UMLS 2011AA ValueDomain
C0454664
NCI Thesaurus Property
C25407
UMLS 2011AA Property
C1442065
NCI Thesaurus ValueDomain-2
C42614
UMLS 2011AA ValueDomain-2
C0027365
Zip code
Description

PersonAddressPostalCode

Data type

text

Alias
NCI Thesaurus ValueDomain
C25162
UMLS 2011AA ValueDomain
C0805701
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C25407
UMLS 2011AA Property
C1442065
Race
Description

Racial Group

Data type

text

Alias
NCI Thesaurus ValueDomain
C25372
UMLS CUI-1
C0034510
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C17049
Method of Payment
Description

PatientPaymentType

Data type

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
General Information
Description

General Information

Pt ID# (Local Patient Identifier)
Description

PatientIdentifier

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ValueDomain
C25364
UMLS 2011AA ValueDomain
C0600091
Last (initial)
Description

Patient Initials Last

Data type

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 (initial)
Description

Patient Initials First

Data type

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 (initial optional)
Description

PatientMiddleInitialsName

Data type

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
E-mail (for Registration Confirmation)
Description

ResponsiblePersonE-mailAddressText

Data type

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
Has patient previously been registered to an ACOSOG study
Description

PriorTherapyPatientAmericanCollegeofSurgeonsOncologyGroupStudyInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ObjectClass-2
C16124
UMLS 2011AA ObjectClass-2
C1514463
NCI Thesaurus Property
C19712
UMLS 2011AA Property
C1515944
NCI Metathesaurus Property
CL238692
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Coordinating Group Patient ID (if yes previously issued ACOSOG Patient ID)
Description

Patient Study ID

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25462
NCI Thesaurus Property-2
C25364
Date Informed Consent Signed (month day year)
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
Was HIPAA Authorization included in Study Informed Consent (mark one)
Description

HealthInsurancePortabilityandAccountabilityActAuthorizationIndicator

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus ObjectClass
C62504
UMLS 2011AA ObjectClass
C0600593
NCI Thesaurus Property
C41192
UMLS 2011AA Property
C1524004
HIPAA Authorization Date (If no month day year)
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
Inclusion Criteria
Description

Inclusion Criteria

Patient must have an ECOG performance status of <= 2 (Zubrod)
Description

EasternCooperativeOncologyGroupPerformanceStatusAssessmentIndicator

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus ObjectClass
C25491
UMLS 2011AA ObjectClass
C1512162
NCI Metathesaurus ObjectClass
CL092952
ECOG Performance Status (Zubrod 0, 1, 2)
Description

ECOG Performance Status

Data type

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS CUI-1
C1520224
NCI Thesaurus Property
C25367
NCI Thesaurus ValueDomain-2
C25491
NCI Thesaurus ObjectClass
C20641
Patient must have T2-T4c, any N, M0 breast cancer, by clinical staging (NOTE: Primary tumor must be palpable and measure >2 cm by tape, ruler or caliper measurements in at least one dimension)
Description

PatientNorthCentralCancerTreatmentGroupAdvancedBreastCarcinomaCancerProgressionEligibilityDeterminationInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25581
UMLS 2011AA Property
C1518419
NCI Thesaurus Property-2
C25411
UMLS 2011AA Property-2
C0205179
NCI Thesaurus Property-3
C4872
UMLS 2011AA Property-3
C0678222
NCI Thesaurus Property-4
C25171
UMLS 2011AA Property-4
C0013893
NCI Thesaurus Property-5
C19987
UMLS 2011AA Property-5
C0242656
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Patient must be postmenopausal, verified by bilateral surgical oophorectomy, no spontaneous menses >= 1 year, or no menses for < 1 year with FSH and estradiol levels in postmenopausal range, according to institutional standards
Description

PatientMenopauseInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C3231
UMLS 2011AA Property
C0025320
Patient, as documented by the treating physician, is clinically staged as one of the following T4 a-c for whom modified radical mastectomy with negative margins is the goal, T2 or T3 for whom conversion from needing mastectomy to breast conservation is the goal, T2 for whom lumpectomy at first attempt is the goal
Description

PatientAdvancedMalignantNeoplasmPriorRegistrationEligibilityDeterminationInd-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
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
Patient has an ER+ tumor with an Allred score of 6, 7 or 8 (Note: Patients with >66.6% two-thirds of cells staining positive have a minimum Allred score of 6 and are eligible)
Description

BreastCarcinomaTumorMarkerPositiveFindingEstrogenReceptorStatusInd-3

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C4872
UMLS 2011AA ObjectClass
C0678222
NCI Thesaurus ObjectClass-2
C17220
UMLS 2011AA ObjectClass-2
C0041365
NCI Thesaurus Property
C38758
UMLS 2011AA Property
C1514241
NCI Thesaurus Property-2
C16150
UMLS 2011AA Property-2
C1516974
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Patient must have mammogram and ultrasound within 42 days prior to registration
Description

MammogramPerformedInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C20178
UMLS 2011AA ObjectClass
C0024671
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
Date of mammogram (<= 42 days prior to registration mm/dd/yyyy)
Description

MammogramPerformedDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C20178
UMLS 2011AA ObjectClass
C0024671
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
Date of Ultrasound (<= 42 days prior to registration mm/dd/yyyy)
Description

DiagnosticImagingUltrasoundImagingPerformedDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C16502
UMLS 2011AA ObjectClass
C0011923
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus Property-2
C17230
UMLS 2011AA Property-2
C0041618
If patient is a cancer survivor, all of the following criteria must be met Patient has undergone potentially curative therapy for all prior malignancies, No evidence of any prior malignancies for at least 5 years with no evidence of recurrence (except for successfully treated cervical carcinoma in situ, lobular carcinoma in situ of the breast, contralateral DCIS treated with mastectomy or lumpectomy and radiation but without tamoxifen treatment, or non-melanoma skin cancer with no evidence of recurrence), and Patient is deemed by their treating physician to be at low risk for recurrence from prior malignancies
Description

PriorCancerDiagnosisIndicator

Data type

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
NCI Thesaurus ObjectClass-2
C25629
UMLS 2011AA ObjectClass-2
C0332152
NCI Thesaurus Property
C15220
UMLS 2011AA Property
C0011900
Exclusion Criteria
Description

Exclusion Criteria

Inflammatory breast cancer defined as clinically significant erythema of the breast and/or documented dermal lymphatic invasion (not direct skin invasion by tumor or peau d'orange without erythema)
Description

DermalLymphaticsInvasionInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C25478
UMLS 2011AA ObjectClass
C0221928
NCI Thesaurus ObjectClass-2
C12746
UMLS 2011AA ObjectClass-2
C0024235
NCI Thesaurus Property
C20625
UMLS 2011AA Property
C1269955
Prior treatment for invasive breast cancer, including radiation, endocrine therapy, chemotherapy or investigational agent (Patients whose diagnosis was established by incisional biopsy are not eligible)
Description

PriorCancerTreatmentInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
NCI Thesaurus ObjectClass-2
C25629
UMLS 2011AA ObjectClass-2
C0332152
NCI Thesaurus Property
C49236
UMLS 2011AA Property
C0087111
Patient has received hormone replacement therapy of any type, megestrol acetate, or raloxifene within one week prior to registration
Description

PatientBreastCarcinomaEndocrineTherapyAdministeredEligibilityDeterminationInd-2

Data type

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
Patient has distant metastasis (M1), excluding isolated ipsilateral supraclavicular node involvement
Description

DistantMetastasisPresentInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus ObjectClass
C25321
UMLS 2011AA ObjectClass
C0443203
NCI Thesaurus ObjectClass-2
C19151
UMLS 2011AA ObjectClass-2
C0027627
Patient does not agree to undergo mastectomy or lumpectomy after neoadjuvant aromatose inhibitor therapy
Description

TotalMastectomyPerformedInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus ObjectClass
C15281
UMLS 2011AA ObjectClass
C0024886
Patient is enrolled in another neoadjuvant clinical trial for treatment of the existing breast cancer
Description

PriorSystemicTherapyInvasiveBreastCarcinomaAdministeredIndicator

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C15698
UMLS 2011AA ObjectClass
C1515119
NCI Thesaurus ObjectClass-2
C25629
UMLS 2011AA ObjectClass-2
C0332152
NCI Thesaurus Property
C9245
UMLS 2011AA Property
C0853879
NCI Thesaurus Property-2
C25382
UMLS 2011AA Property-2
C1521801
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
Patient has undergone prior sentinel lymph node biopsy (Cohort B only)
Description

SentinelNodeBiopsyInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C15189
UMLS 2011AA Property
C0005558
NCI Thesaurus ObjectClass
C12947
UMLS 2011AA ObjectClass
C1522495
Randomization
Description

Randomization

Treatment Arm
Description

AmericanCollegeofSurgeonsOncologyGroupTreatmentArmRandomizationAmericanCollegeofSurgeonsOncologyGroupTreatmentArmRandomizationType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus Property
C25196
UMLS 2011AA Property
C0034656
NCI Thesaurus ObjectClass
C19712
UMLS 2011AA ObjectClass
C1515944
NCI Thesaurus ObjectClass-2
C15538
UMLS 2011AA ObjectClass-2
C1522541
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1 forms
  1. StudyEvent: ACOSOG-Z1031 OPEN Registration Worksheet
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header Module
TreatingInstitutionTextCode
Item
Institution CTEP ID
text
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C25705 (NCI Thesaurus ObjectClass)
C1522326 (UMLS 2011AA ObjectClass)
C19992 (NCI Thesaurus ObjectClass-2)
C1516607 (UMLS 2011AA ObjectClass-2)
CL281747 (NCI Metathesaurus Property)
Institution Name
Item
Institution Name
text
C25191 (NCI Thesaurus ValueDomain)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass)
C21541 (NCI Thesaurus ValueDomain-2)
C25364 (NCI Thesaurus Property)
Protocol ID ACOSOG
Item
Protocol Number
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1515944 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C19712 (NCI Thesaurus Property-2)
Protocol Title
Item
Protocol Title
text
C25191 (NCI Thesaurus ValueDomain)
C2986303 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C42774 (NCI Thesaurus Property)
Registration Number
Item
Registration Step
text
C25337 (NCI Thesaurus ValueDomain)
C1514821 (UMLS CUI-1)
C25646 (NCI Thesaurus ObjectClass)
C0237753 (UMLS CUI-2)
C16154 (NCI Thesaurus Property)
C16154 (NCI Thesaurus ValueDomain-2)
TreatingPhysicianOrParticipatingInvestigatorName
Item
Treating Investigator
text
C25608 (NCI Thesaurus ObjectClass)
C0679823 (UMLS 2011AA ObjectClass)
C37998 (NCI Thesaurus ObjectClass-2)
C1518602 (UMLS 2011AA ObjectClass-2)
C51883 (NCI Thesaurus ObjectClass-3)
C1710470 (UMLS 2011AA ObjectClass-3)
C25936 (NCI Thesaurus ObjectClass-4)
C0035173 (UMLS 2011AA ObjectClass-4)
C25191 (NCI Thesaurus Property)
C1547383 (UMLS 2011AA Property)
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
Protocol Registrar
Item
Site Registrar
text
C25191 (NCI Thesaurus ValueDomain)
C1507394 (UMLS CUI-1)
C25364 (NCI Thesaurus Property)
C0557514 (UMLS CUI-2)
C25357 (NCI Thesaurus ObjectClass)
ClinicalTrialsCooperativeGroupRegisteringInstitutionIdentifierCode
Item
Cooperative Group (Credit)
text
C41206 (NCI Thesaurus ObjectClass)
C1272753 (UMLS 2011AA ObjectClass)
C25645 (NCI Thesaurus ObjectClass-2)
C18205 (NCI Thesaurus ObjectClass-3)
C1521808 (UMLS 2011AA ObjectClass-2)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
InvestigatorName
Item
Investigator (Credit)
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C17089 (NCI Thesaurus ObjectClass)
C0035173 (UMLS 2011AA ObjectClass)
Research Comments
Item
Comments (Enter case notes optional)
text
C25704 (NCI Thesaurus ValueDomain)
C0947611 (UMLS CUI-1)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
Item Group
Patient Information
PersonBirthDate
Item
Date of Birth (month day year)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25155 (NCI Thesaurus Property)
C0005615 (UMLS 2011AA Property)
Item
Gender of a Person
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C17357 (NCI Thesaurus Property)
C0079399 (UMLS 2011AA Property)
CL.1
Code List
Gender of a Person
CL Item
Female Gender (Female)
C46110 (NCI Thesaurus)
C0086287 (UMLS 2011AA)
CL Item
Male Gender (Male)
C46109 (NCI Thesaurus)
C1706180 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
Ethnicity
text
C25372 (NCI Thesaurus Property)
C0683312 (UMLS 2011AA Property)
C25372 (NCI Thesaurus ValueDomain)
C0683312 (UMLS 2011AA ValueDomain)
C16564 (NCI Thesaurus ObjectClass)
C0015031 (UMLS 2011AA ObjectClass)
CL.2
Code List
Ethnicity
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)
PersonAddressCountryName
Item
Country of Residence
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25464 (NCI Thesaurus ValueDomain)
C0454664 (UMLS 2011AA ValueDomain)
C25407 (NCI Thesaurus Property)
C1442065 (UMLS 2011AA Property)
C42614 (NCI Thesaurus ValueDomain-2)
C0027365 (UMLS 2011AA ValueDomain-2)
PersonAddressPostalCode
Item
Zip code
text
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25407 (NCI Thesaurus Property)
C1442065 (UMLS 2011AA Property)
Item
Race
text
C25372 (NCI Thesaurus ValueDomain)
C0034510 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C17049 (NCI Thesaurus Property)
CL.3
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
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)
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)
Item
Method of Payment
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
CL Item
Medicaid (Medicaid)
C0025071 (NCI Metathesaurus)
CL Item
Medicaid And Medicare (Medicaid and Medicare)
CL Item
Medicare (Medicare)
C16665 (NCI Thesaurus)
C0018717 (UMLS 2011AA)
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
No Means Of Payment (no Insurance) (No means of payment (no insurance))
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Private Insurance (Private Insurance)
CL Item
Self Pay (no Insurance) (Self Pay (No Insurance))
CL Item
Veterans Sponsored (Veterans Sponsored)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item Group
General Information
PatientIdentifier
Item
Pt ID# (Local Patient Identifier)
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25364 (NCI Thesaurus ValueDomain)
C0600091 (UMLS 2011AA ValueDomain)
Patient Initials Last
Item
Last (initial)
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 (initial)
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 (initial optional)
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)
ResponsiblePersonE-mailAddressText
Item
E-mail (for Registration Confirmation)
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)
PriorTherapyPatientAmericanCollegeofSurgeonsOncologyGroupStudyInd-2
Item
Has patient previously been registered to an ACOSOG study
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C16124 (NCI Thesaurus ObjectClass-2)
C1514463 (UMLS 2011AA ObjectClass-2)
C19712 (NCI Thesaurus Property)
C1515944 (UMLS 2011AA Property)
CL238692 (NCI Metathesaurus Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Patient Study ID
Item
Coordinating Group Patient ID (if yes previously issued ACOSOG Patient ID)
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25462 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
InformedConsentFormSignedDate
Item
Date Informed Consent Signed (month day year)
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)
HealthInsurancePortabilityandAccountabilityActAuthorizationIndicator
Item
Was HIPAA Authorization included in Study Informed Consent (mark one)
boolean
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C62504 (NCI Thesaurus ObjectClass)
C0600593 (UMLS 2011AA ObjectClass)
C41192 (NCI Thesaurus Property)
C1524004 (UMLS 2011AA Property)
PatientSignedDischargeMedicalRecordDate
Item
HIPAA Authorization Date (If no month day year)
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)
Item Group
Inclusion Criteria
EasternCooperativeOncologyGroupPerformanceStatusAssessmentIndicator
Item
Patient must have an ECOG performance status of <= 2 (Zubrod)
boolean
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C25491 (NCI Thesaurus ObjectClass)
C1512162 (UMLS 2011AA ObjectClass)
CL092952 (NCI Metathesaurus ObjectClass)
Item
ECOG Performance Status (Zubrod 0, 1, 2)
text
C25664 (NCI Thesaurus ValueDomain)
C1520224 (UMLS CUI-1)
C25367 (NCI Thesaurus Property)
C25491 (NCI Thesaurus ValueDomain-2)
C20641 (NCI Thesaurus ObjectClass)
CL.8
Code List
ECOG Performance Status (Zubrod 0, 1, 2)
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)
PatientNorthCentralCancerTreatmentGroupAdvancedBreastCarcinomaCancerProgressionEligibilityDeterminationInd-2
Item
Patient must have T2-T4c, any N, M0 breast cancer, by clinical staging (NOTE: Primary tumor must be palpable and measure >2 cm by tape, ruler or caliper measurements in at least one dimension)
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25581 (NCI Thesaurus Property)
C1518419 (UMLS 2011AA Property)
C25411 (NCI Thesaurus Property-2)
C0205179 (UMLS 2011AA Property-2)
C4872 (NCI Thesaurus Property-3)
C0678222 (UMLS 2011AA Property-3)
C25171 (NCI Thesaurus Property-4)
C0013893 (UMLS 2011AA Property-4)
C19987 (NCI Thesaurus Property-5)
C0242656 (UMLS 2011AA Property-5)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PatientMenopauseInd-2
Item
Patient must be postmenopausal, verified by bilateral surgical oophorectomy, no spontaneous menses >= 1 year, or no menses for < 1 year with FSH and estradiol levels in postmenopausal range, according to institutional standards
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C3231 (NCI Thesaurus Property)
C0025320 (UMLS 2011AA Property)
PatientAdvancedMalignantNeoplasmPriorRegistrationEligibilityDeterminationInd-2
Item
Patient, as documented by the treating physician, is clinically staged as one of the following T4 a-c for whom modified radical mastectomy with negative margins is the goal, T2 or T3 for whom conversion from needing mastectomy to breast conservation is the goal, T2 for whom lumpectomy at first attempt is the goal
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)
BreastCarcinomaTumorMarkerPositiveFindingEstrogenReceptorStatusInd-3
Item
Patient has an ER+ tumor with an Allred score of 6, 7 or 8 (Note: Patients with >66.6% two-thirds of cells staining positive have a minimum Allred score of 6 and are eligible)
boolean
C4872 (NCI Thesaurus ObjectClass)
C0678222 (UMLS 2011AA ObjectClass)
C17220 (NCI Thesaurus ObjectClass-2)
C0041365 (UMLS 2011AA ObjectClass-2)
C38758 (NCI Thesaurus Property)
C1514241 (UMLS 2011AA Property)
C16150 (NCI Thesaurus Property-2)
C1516974 (UMLS 2011AA Property-2)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
MammogramPerformedInd-3
Item
Patient must have mammogram and ultrasound within 42 days prior to registration
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C20178 (NCI Thesaurus ObjectClass)
C0024671 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
MammogramPerformedDate
Item
Date of mammogram (<= 42 days prior to registration mm/dd/yyyy)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C20178 (NCI Thesaurus ObjectClass)
C0024671 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
DiagnosticImagingUltrasoundImagingPerformedDate
Item
Date of Ultrasound (<= 42 days prior to registration mm/dd/yyyy)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16502 (NCI Thesaurus ObjectClass)
C0011923 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C17230 (NCI Thesaurus Property-2)
C0041618 (UMLS 2011AA Property-2)
Item
If patient is a cancer survivor, all of the following criteria must be met Patient has undergone potentially curative therapy for all prior malignancies, No evidence of any prior malignancies for at least 5 years with no evidence of recurrence (except for successfully treated cervical carcinoma in situ, lobular carcinoma in situ of the breast, contralateral DCIS treated with mastectomy or lumpectomy and radiation but without tamoxifen treatment, or non-melanoma skin cancer with no evidence of recurrence), and Patient is deemed by their treating physician to be at low risk for recurrence from prior malignancies
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
CL.14
Code List
If patient is a cancer survivor, all of the following criteria must be met Patient has undergone potentially curative therapy for all prior malignancies, No evidence of any prior malignancies for at least 5 years with no evidence of recurrence (except for successfully treated cervical carcinoma in situ, lobular carcinoma in situ of the breast, contralateral DCIS treated with mastectomy or lumpectomy and radiation but without tamoxifen treatment, or non-melanoma skin cancer with no evidence of recurrence), and Patient is deemed by their treating physician to be at low risk for recurrence from prior malignancies
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)
Item Group
Exclusion Criteria
DermalLymphaticsInvasionInd-3
Item
Inflammatory breast cancer defined as clinically significant erythema of the breast and/or documented dermal lymphatic invasion (not direct skin invasion by tumor or peau d'orange without erythema)
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25478 (NCI Thesaurus ObjectClass)
C0221928 (UMLS 2011AA ObjectClass)
C12746 (NCI Thesaurus ObjectClass-2)
C0024235 (UMLS 2011AA ObjectClass-2)
C20625 (NCI Thesaurus Property)
C1269955 (UMLS 2011AA Property)
PriorCancerTreatmentInd-2
Item
Prior treatment for invasive breast cancer, including radiation, endocrine therapy, chemotherapy or investigational agent (Patients whose diagnosis was established by incisional biopsy are not eligible)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C49236 (NCI Thesaurus Property)
C0087111 (UMLS 2011AA Property)
PatientBreastCarcinomaEndocrineTherapyAdministeredEligibilityDeterminationInd-2
Item
Patient has received hormone replacement therapy of any type, megestrol acetate, or raloxifene within one week prior to registration
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)
DistantMetastasisPresentInd-2
Item
Patient has distant metastasis (M1), excluding isolated ipsilateral supraclavicular node involvement
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C25321 (NCI Thesaurus ObjectClass)
C0443203 (UMLS 2011AA ObjectClass)
C19151 (NCI Thesaurus ObjectClass-2)
C0027627 (UMLS 2011AA ObjectClass-2)
TotalMastectomyPerformedInd-2
Item
Patient does not agree to undergo mastectomy or lumpectomy after neoadjuvant aromatose inhibitor therapy
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C15281 (NCI Thesaurus ObjectClass)
C0024886 (UMLS 2011AA ObjectClass)
PriorSystemicTherapyInvasiveBreastCarcinomaAdministeredIndicator
Item
Patient is enrolled in another neoadjuvant clinical trial for treatment of the existing breast cancer
boolean
C15698 (NCI Thesaurus ObjectClass)
C1515119 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C9245 (NCI Thesaurus Property)
C0853879 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
SentinelNodeBiopsyInd-2
Item
Patient has undergone prior sentinel lymph node biopsy (Cohort B only)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C15189 (NCI Thesaurus Property)
C0005558 (UMLS 2011AA Property)
C12947 (NCI Thesaurus ObjectClass)
C1522495 (UMLS 2011AA ObjectClass)
Item Group
Randomization
Item
Treatment Arm
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25196 (NCI Thesaurus Property)
C0034656 (UMLS 2011AA Property)
C19712 (NCI Thesaurus ObjectClass)
C1515944 (UMLS 2011AA ObjectClass)
C15538 (NCI Thesaurus ObjectClass-2)
C1522541 (UMLS 2011AA ObjectClass-2)
CL.22
Code List
Treatment Arm
CL Item
Patient Chosen Arm (Patient chosen arm)
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