ID

11817

Description

NCIC MA.32 Eligibility Worksheet A Phase III Randomized Trial of Metformin vs Placebo in Early Stage Breast Cancer NCT01101438 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=80D63865-BE43-3FAC-E040-BB89AD4349FC

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=80D63865-BE43-3FAC-E040-BB89AD4349FC

Keywords

Versions (4)
  1. 8/8/14 8/8/14 - Martin Dugas
  2. 1/9/15 1/9/15 - Martin Dugas
  3. 3/23/15 3/23/15 - Martin Dugas
  4. 8/4/15 8/4/15 - Martin Dugas
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August 4, 2015

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License

Creative Commons BY-NC 3.0 Legacy
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Eligibility Breast Cancer early stage NCIC MA.32 NCT01101438

English

No Instruction available.

1 forms  
  1. StudyEvent: NCIC MA.32 Eligibility Worksheet
    1. No Instruction available.
Header Module
Description

Header Module

Institution Code
Description

Institution Number

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C1301943
NCI Thesaurus ObjectClass
C21541
UMLS CUI-2
C0805701
NCI Thesaurus Property
C25364
Patient Initials
Description

Patient Initials

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
Hospital Number (if permitted by REB)
Description

Medical Record Number

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C1301894
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25261
NCI Thesaurus Property-2
C25198
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
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
Patient Characteristics
Description

Patient Characteristics

Patient Race
Description

Racial Group

Data type

text

Alias
NCI Thesaurus ValueDomain
C25372
UMLS CUI-1
C0034510
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C17049
Patient Ethnicity
Description

Ethnic Group

Data type

text

Alias
NCI Thesaurus ValueDomain
C25372
UMLS CUI-1
C0015031
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C16564
Eligibility Criteria
Description

Eligibility Criteria

Subject has histologically confirmed invasive breast cancer that has been diagnosed and completely resected within 12 months prior to randomization
Description

InvasiveBreastCarcinomaHistologicallyConfirmedInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C4872
UMLS 2011AA ObjectClass
C0678222
NCI Thesaurus ObjectClass-2
C14159
UMLS 2011AA ObjectClass-2
C0205281
NCI Thesaurus ObjectClass-3
C25527
UMLS 2011AA ObjectClass-3
C0205462
NCI Thesaurus Property
C25458
UMLS 2011AA Property
C0750484
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Tumor Laterality
Description

PrimaryTumorLateralityType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus ObjectClass-2
C25251
UMLS 2011AA ObjectClass-2
C0205225
NCI Thesaurus Property
C25185
UMLS 2011AA Property
C0332304
Date of Initial Diagnosis of Primary Tumor
Description

FirstBiopsyPositiveDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C15189
UMLS 2011AA ObjectClass
C0005558
NCI Thesaurus ObjectClass-2
C25509
UMLS 2011AA ObjectClass-2
C1279901
NCI Thesaurus Property
C25246
UMLS 2011AA Property
C1446409
NCI Thesaurus Property-2
C25275
UMLS 2011AA Property-2
C2745955
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25367
Histologic Type
Description

BreastTumorHistologicCategory

Data type

text

Alias
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus ObjectClass-2
C12971
UMLS 2011AA ObjectClass-2
C0006141
NCI Thesaurus Property
C25526
UMLS 2011AA Property
C0205462
NCI Thesaurus Property-2
C25161
UMLS 2011AA Property-2
C0008902
NCI Thesaurus ValueDomain
C25372
UMLS 2011AA ValueDomain
C0683312
NCI Thesaurus ValueDomain-2
C25526
UMLS 2011AA ValueDomain-2
C0205462
Most extensive definitive surgery
Description

BreastPrimarySurgicalProcedurePerformedType

Data type

text

Alias
NCI Thesaurus ObjectClass
C25251
UMLS 2011AA ObjectClass
C0205225
NCI Thesaurus ObjectClass-2
C12971
UMLS 2011AA ObjectClass-2
C0006141
NCI Thesaurus ObjectClass-3
C15329
UMLS 2011AA ObjectClass-3
C0543467
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Date of Most Extensive Primary Surgery
Description

PrimarySurgeryDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C25251
UMLS 2011AA ObjectClass
C0205225
NCI Thesaurus ObjectClass-2
C15329
UMLS 2011AA ObjectClass-2
C0543467
NCI Thesaurus Property
C25275
UMLS 2011AA Property
C2745955
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25367
Is invasive cancer at margin?
Description

InvasiveCancerSurgicalMarginResultType

Data type

text

Alias
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
NCI Thesaurus ObjectClass-2
C14159
UMLS 2011AA ObjectClass-2
C0205281
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C41227
UMLS 2011AA Property-2
C0229985
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Is DCIS present? (at resection margin)
Description

DCISDiagnosisInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C2924
UMLS 2011AA ObjectClass
C0007124
NCI Thesaurus Property
C15220
UMLS 2011AA Property
C0011900
Has the subject received adjuvant radiotherapy
Description

AdjuvantRadiationTherapyAdministeredInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C15313
UMLS 2011AA ObjectClass
C1522449
NCI Thesaurus ObjectClass-2
C2140
UMLS 2011AA ObjectClass-2
C0001552
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Was a boost given? (to the site of residual ductal in situ disease)
Description

RadiationTherapyBoostAdministeredind-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C15313
UMLS 2011AA ObjectClass
C1522449
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus Property-2
C25438
UMLS 2011AA Property-2
C1511253
If neoadjuvant, subject has no evidence of clinical T4 disease prior to chemotherapy and surgery
Description

NeoadjuvantTherapyPatientDiseaseorDisorderEligibilityDeterminationInd-4

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus ObjectClass-2
C15665
NCI Thesaurus Property
C2991
NCI Thesaurus Property-2
C25171
NCI Thesaurus ValueDomain
C49486
T Stage, Clinical
Description

BreastTumorClinicalTStage

Data type

text

Alias
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus ObjectClass-2
C12971
UMLS 2011AA ObjectClass-2
C0006141
NCI Thesaurus Property
C25398
UMLS 2011AA Property
C0205210
NCI Thesaurus Property-2
C25728
UMLS 2011AA Property-2
C0475455
NCI Thesaurus ValueDomain
C16899
UMLS 2011AA ValueDomain
C1300072
N Stage, Clinical
Description

BreastTumorClinicalNStage

Data type

text

Alias
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus ObjectClass-2
C12971
UMLS 2011AA ObjectClass-2
C0006141
NCI Thesaurus Property
C25398
UMLS 2011AA Property
C0205210
NCI Thesaurus Property-2
C25580
UMLS 2011AA Property-2
C0456532
NCI Thesaurus ValueDomain
C16899
UMLS 2011AA ValueDomain
C1300072
M Stage, Clinical
Description

BreastTumorClinicalMStage

Data type

text

Alias
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus ObjectClass-2
C12971
UMLS 2011AA ObjectClass-2
C0006141
NCI Thesaurus Property
C25398
UMLS 2011AA Property
C0205210
NCI Thesaurus Property-2
C25727
UMLS 2011AA Property-2
C0456533
NCI Thesaurus ValueDomain
C16899
UMLS 2011AA ValueDomain
C1300072
Subject's TNM Stage (AJCC Version 6) is one of pT1, pT2, pT3; pN0, pN1, pN2, pN3; M0 and subject has one of the pT pN combinations described in protocol section 5.1.4 and subject has sentinel node biopsy and/or full axillary lymph node dissection
Description

PatientTNMStagingSystemEligibilityDeterminationInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25171
NCI Thesaurus Property-2
C25384
Pathologic T Stage
Description

BreastTumorPathologicTStage

Data type

text

Alias
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus ObjectClass-2
C12971
UMLS 2011AA ObjectClass-2
C0006141
NCI Thesaurus Property
C25610
UMLS 2011AA Property
C1521733
NCI Thesaurus Property-2
C25728
UMLS 2011AA Property-2
C0475455
NCI Thesaurus ValueDomain
C16899
UMLS 2011AA ValueDomain
C1300072
Pathologic N Stage
Description

BreastTumorPathologicNStage

Data type

text

Alias
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus ObjectClass-2
C12971
UMLS 2011AA ObjectClass-2
C0006141
NCI Thesaurus Property
C25610
UMLS 2011AA Property
C1521733
NCI Thesaurus Property-2
C25580
UMLS 2011AA Property-2
C0456532
NCI Thesaurus ValueDomain
C16899
UMLS 2011AA ValueDomain
C1300072
Pathologic M Stage
Description

BreastTumorPathologicMStage

Data type

text

Alias
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus ObjectClass-2
C12971
UMLS 2011AA ObjectClass-2
C0006141
NCI Thesaurus Property
C25610
UMLS 2011AA Property
C1521733
NCI Thesaurus Property-2
C25727
UMLS 2011AA Property-2
C0456533
NCI Thesaurus ValueDomain
C16899
UMLS 2011AA ValueDomain
C1300072
Histologic Grade
Description

BreastTumorHistologicGrade

Data type

text

Alias
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus ObjectClass-2
C12971
UMLS 2011AA ObjectClass-2
C0006141
NCI Thesaurus Property
C25526
UMLS 2011AA Property
C0205462
NCI Thesaurus Property-2
C25365
UMLS 2011AA Property-2
C0678257
NCI Thesaurus ValueDomain
C25526
UMLS 2011AA ValueDomain
C0205462
NCI Thesaurus ValueDomain-2
C18000
UMLS 2011AA ValueDomain-2
C0919553
Is there lymphovascular invasion?
Description

TumorLymphovascularInvasionInd

Data type

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus Property
C20625
UMLS 2011AA Property
C1269955
NCI Thesaurus Property-2
C25561
UMLS 2011AA Property-2
C1518090
Oncotype DX Recurrence Score
Description

LaboratoryProcedureOncotypeDXBreastCancerAssayResultScore

Data type

float

Alias
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property-2
C52159
UMLS 2011AA Property-2
C1709318
NCI Thesaurus ValueDomain
C25338
UMLS 2011AA ValueDomain
C0449820
Ki67 Score
Description

LaboratoryProcedureTumorMarkerKi-67AntigenResultValue

Data type

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C17220
UMLS 2011AA Property-2
C0041365
NCI Thesaurus Property-3
C17675
UMLS 2011AA Property-3
C0208804
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
Was sentinel node sampling performed
Description

SentinelNodeBiopsyInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C15189
UMLS 2011AA Property
C0005558
NCI Thesaurus ObjectClass
C12947
UMLS 2011AA ObjectClass
C1522495
Sentinel Node Biopsy Date
Description

SentinelNodeBiopsyDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus Property
C15189
UMLS 2011AA Property
C0005558
NCI Thesaurus ObjectClass
C12947
UMLS 2011AA ObjectClass
C1522495
Number of Sentinel Nodes Examined
Description

SentinelNodeExaminedCount

Data type

float

Alias
NCI Thesaurus Property
C25500
UMLS 2011AA Property
C0332128
NCI Thesaurus ValueDomain
C25463
UMLS 2011AA ValueDomain
C0750480
NCI Thesaurus ObjectClass
C12947
UMLS 2011AA ObjectClass
C1522495
Number of Positive Sentinel Nodes
Description

SentinelNodePositiveAssessmentCount

Data type

float

Alias
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Metathesaurus Property
C0205159
NCI Thesaurus ValueDomain
C25463
UMLS 2011AA ValueDomain
C0750480
NCI Thesaurus ObjectClass
C12947
UMLS 2011AA ObjectClass
C1522495
Was axillary dissection performed?
Description

AxillaryNodeDissectionInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C15227
UMLS 2011AA Property
C0012737
NCI Thesaurus ObjectClass
C12904
UMLS 2011AA ObjectClass
C0729594
Date of Axillary Node Biopsy
Description

AxillaryLymphNodeCoreBiopsyFine-NeedleAspirationLymphNodeBiopsyPriorClinicalStudyPerformedDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C15680
NCI Thesaurus ObjectClass-2
C15361
NCI Thesaurus ObjectClass-3
C51900
NCI Thesaurus ObjectClass-4
C12904
NCI Thesaurus Property
C38000
NCI Thesaurus Property-2
C25629
NCI Thesaurus Property-3
C15206
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C0193842
UMLS CUI-2
C0729594
UMLS CUI-3
C0011008
Number of axillary nodes examined
Description

AxillaryNodeExaminedTotalCount

Data type

float

Alias
NCI Thesaurus ValueDomain
C25304
UMLS 2011AA ValueDomain
C0439810
NCI Thesaurus Property
C25500
UMLS 2011AA Property
C0332128
NCI Thesaurus ValueDomain-2
C25463
UMLS 2011AA ValueDomain-2
C0750480
NCI Thesaurus ObjectClass
C12904
UMLS 2011AA ObjectClass
C0729594
Number of positive axillary nodes
Description

PositiveAxillaryNodeExaminedTotalCount

Data type

float

Alias
NCI Thesaurus ObjectClass
C25246
UMLS 2011AA ObjectClass
C1446409
NCI Thesaurus ObjectClass-2
C12904
UMLS 2011AA ObjectClass-2
C0729594
NCI Thesaurus Property
C25500
UMLS 2011AA Property
C0332128
NCI Thesaurus ValueDomain
C25304
UMLS 2011AA ValueDomain
C0439810
NCI Thesaurus ValueDomain-2
C25463
UMLS 2011AA ValueDomain-2
C0750480
Number of Lymph Nodes Examined
Description

LymphNodeExaminedCount

Data type

float

Alias
NCI Thesaurus Property
C25500
UMLS 2011AA Property
C0332128
NCI Thesaurus ObjectClass
C12745
UMLS 2011AA ObjectClass
C0024204
NCI Thesaurus ValueDomain
C25463
UMLS 2011AA ValueDomain
C0750480
Number of Positive Lymph Nodes
Description

LymphNodePositiveCount

Data type

float

Alias
NCI Thesaurus Property
C25246
UMLS 2011AA Property
C1446409
NCI Thesaurus ObjectClass
C12745
UMLS 2011AA ObjectClass
C0024204
NCI Thesaurus ValueDomain
C25463
UMLS 2011AA ValueDomain
C0750480
If subject has bilateral breast carcinoma diagnoses were synchronous - within 3 months of one another - and at least one of the two breast carcinomas meet the eligibility criteria and neither meets the exclusion criteria
Description

PatientBilateralBreastCarcinomaEligibilityDeterminationInd-4

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C13332
NCI Thesaurus Property-2
C4872
NCI Thesaurus Property-3
C25171
NCI Thesaurus ValueDomain
C49486
UMLS CUI-1
C0238767
UMLS CUI-2
C0678222
Chemotherapy, if given, has been completed at least 4 weeks prior to randomization
Description

PatientChemotherapyEligibilityDeterminationInd-4

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C15632
UMLS 2011AA Property
C0392920
NCI Thesaurus Property-2
C25171
UMLS 2011AA Property-2
C0013893
NCI Thesaurus ValueDomain
C49486
UMLS 2011AA ValueDomain
C1704854
Prior Adjuvant Chemotherapy
Description

PriorAdjuvantChemotherapyAdministeredInd-2

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
C2140
UMLS 2011AA ObjectClass-3
C0001552
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Date Prior Adjuvant Chemotherapy Ended
Description

AdjuvantChemotherapyPriorEndDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C15632
UMLS 2011AA ObjectClass
C0392920
NCI Thesaurus ObjectClass-2
C2140
UMLS 2011AA ObjectClass-2
C0001552
NCI Thesaurus Property
C25629
UMLS 2011AA Property
C0332152
NCI Thesaurus Property-2
C25275
UMLS 2011AA Property-2
C2745955
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Estrogen/progesterone receptor status is known
Description

PatientEstrogenReceptorStatusProgesteroneReceptorStatusEligibilityDeterminationInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25171
NCI Thesaurus Property-2
C16149
NCI Thesaurus Property-3
C16150
NCI Thesaurus ValueDomain
C38147
UMLS CUI-1
C1514471
UMLS CUI-2
C1516974
Receptor Status, ER
Description

ERLevelTumorStatus

Data type

text

Alias
NCI Thesaurus ValueDomain
C3262
UMLS 2011AA ValueDomain
C0027651
NCI Thesaurus ObjectClass
C17069
UMLS 2011AA ObjectClass
C0034804
NCI Thesaurus ValueDomain-2
C25688
UMLS 2011AA ValueDomain-2
C0449438
NCI Thesaurus Property
C25554
UMLS 2011AA Property
C0441889
Receptor Status, PgR
Description

PgRStatusType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C17075
UMLS 2011AA ObjectClass
C0034833
NCI Metathesaurus Property
C0678257
HER2 status is known
Description

PatientHER2/neuEligibilityDeterminationInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25171
UMLS 2011AA Property
C0013893
NCI Thesaurus Property-2
C17756
UMLS 2011AA Property-2
C0242957
HER-2/neu status
Description

HER2/neuStatusType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C17756
UMLS 2011AA ObjectClass
C0242957
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
HER2 test type
Description

LaboratoryProcedureHER2/neuStatusMethodType

Data type

text

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C71460
UMLS 2011AA Property
C0025663
NCI Thesaurus Property-2
C17756
UMLS 2011AA Property-2
C0242957
NCI Thesaurus Property-3
C25688
UMLS 2011AA Property-3
C0449438
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Specify (If other,)
Description

LaboratoryProcedureHER2/neuStatusMethodSpecify

Data type

text

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C71460
UMLS 2011AA Property
C0025663
NCI Thesaurus Property-2
C17756
UMLS 2011AA Property-2
C0242957
NCI Thesaurus Property-3
C25688
UMLS 2011AA Property-3
C0449438
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
Subject has had a bilateral mammogram within 12 months prior to randomization
Description

PatientBilateralMammogramEligibilityDeterminationInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C20178
UMLS 2011AA Property
C0024671
NCI Thesaurus Property-2
C13332
UMLS 2011AA Property-2
C0238767
NCI Thesaurus Property-3
C25171
UMLS 2011AA Property-3
C0013893
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Date of mammogram
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
Subject has ECOG Performance Status of 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
C1512162
ECOG Performance Status
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
Subject is < 75 years of age and has life expectancy of at least 5 years
Description

PatientAgeEligibilityDeterminationInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25150
UMLS 2011AA Property
C0001779
NCI Thesaurus Property-2
C25171
UMLS 2011AA Property-2
C0013893
Patient date of birth
Description

Patient date of birth

Data type

date

Measurement units
  • DD.MM.YYYY
Alias
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ObjectClass
C25190
NCI Thesaurus Property
C25155
UMLS CUI [1]
C0421451
DD.MM.YYYY
Age
Description

Age

Data type

integer

Measurement units
  • years
Alias
NCI Thesaurus ValueDomain
C25337
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25150
UMLS CUI [1]
C0001779
years
Subject is accessible for treatment and follow-up
Description

PatientTherapeuticProcedureFollow-upEligibilityDeterminationInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C16033
NCI Thesaurus Property-2
C49236
NCI Thesaurus Property-3
C25171
NCI Thesaurus ValueDomain
C38147
Protocol treatment will begin within 10 working days after randomization
Description

TherapyBeginRequirementInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25431
UMLS 2011AA Property
C0439659
NCI Thesaurus Property-2
C38015
Most recent REB approved informed consent has been signed according to local institutional requirements
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
Most recent REB approved Tissue and Blood Collection and Banking informed consent has been signed and dated by the patient and appropriate "I agree/I don't agree" box has been checked
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
Date tissue and blood collection and banking consent signed
Description

PatientCorrelativeStudySpecimenConsentDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
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
Tissue and blood collection and banking consent version date
Description

PatientCorrelativeStudySpecimenConsentVersionDate

Data type

text

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
C25164
UMLS 2011AA ValueDomain
C0011008
Is the subject English or French speaking
Description

PatientEnglishFrenchLanguageEligibilityDeterminationInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C43853
NCI Thesaurus Property-2
C16779
NCI Thesaurus Property-3
C43854
NCI Thesaurus Property-4
C25171
NCI Thesaurus ValueDomain
C38147
UMLS CUI-1
C0745640
UMLS CUI-2
C0376246
Subject has completed the baseline Quality of Life questionnaire and is willing to complete future assessments
Description

PersonQualityofLifeCompleteAgreementIndicator

Data type

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C17047
UMLS 2011AA Property
C0518214
NCI Thesaurus Property-2
C25250
UMLS 2011AA Property-2
C0205197
NCI Thesaurus Property-3
C25369
UMLS 2011AA Property-3
C0680240
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
Date Questionnaire Completed
Description

QualityofLifeCompleteAssessmentDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C17047
UMLS 2011AA ObjectClass
C0518214
NCI Thesaurus Property
C25250
UMLS 2011AA Property
C0205197
NCI Thesaurus Property-2
C25367
Reason questionnaire was not completed
Description

PatientQuestionnaireCompleteNotAdministeredReason

Data type

text

Alias
NCI Thesaurus ValueDomain
C25638
UMLS 2011AA ValueDomain
C0392360
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25250
UMLS 2011AA Property
C0205197
NCI Thesaurus Property-2
C17048
UMLS 2011AA Property-2
C0034394
Specify
Description

PatientIncompleteQuestionnaireOtherSpecify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ValueDomain-2
C17649
UMLS 2011AA ValueDomain-2
C0205394
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Metathesaurus Property
C0034394
Is the subject English speaking and has s/he already completed the Quality of Life questionnaire
Description

PatientEnglishLanguageEligibilityDeterminationInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C82847
UMLS 2011AA Property
C0376245
NCI Thesaurus Property-2
C25171
UMLS 2011AA Property-2
C0013893
Subject has completed the baseline Nurses Health Study II Physical Activity Questionnaire and the Block Alive Screener and is willing to complete future assessments
Description

AdditionalFormCompleteIndicator

Data type

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus ObjectClass
C19464
UMLS 2011AA ObjectClass
C0376315
NCI Thesaurus Property
C25250
UMLS 2011AA Property
C0205197
NCI Thesaurus ObjectClass-2
C25406
UMLS 2011AA ObjectClass-2
C1524062
Date patient filled out questionnaires
Description

AdditionalFormCompleteDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C19464
UMLS 2011AA ObjectClass
C0376315
NCI Thesaurus Property
C25250
UMLS 2011AA Property
C0205197
NCI Thesaurus ObjectClass-2
C25406
UMLS 2011AA ObjectClass-2
C1524062
Investigations, including chest X-ray or CT chest, bone scan and abdominal have been performed no earlier than 4 weeks prior to primary surgery and no later than the date of randomization and are negative for metastases
Description

LaboratoryProcedurePriorTherapeuticProcedurePerformedInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus Property
C38000
NCI Thesaurus Property-2
C25629
NCI Thesaurus Property-3
C49236
NCI Thesaurus ValueDomain
C38147
Date of Chest X-ray
Description

ChestX-RayAssessmentDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus ObjectClass
C25389
UMLS 2011AA ObjectClass
C0817096
NCI Thesaurus ObjectClass-2
C17261
Date of CT or MRI of chest
Description

ChestComputedTomographyMagneticResonanceImagingDiagnosticImagingPerformedDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C16502
NCI Thesaurus ObjectClass-2
C17204
NCI Thesaurus ObjectClass-3
C25389
NCI Thesaurus ObjectClass-4
C16809
NCI Thesaurus Property
C38000
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C0817096
UMLS CUI-2
C0040405
UMLS CUI-3
C0024485
UMLS CUI-4
C0011008
Date of bone scan
Description

BoneScanMedicalImagingAssessmentDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C25367
NCI Thesaurus ObjectClass
C17646
UMLS 2011AA ObjectClass
C0203668
NCI Thesaurus ObjectClass-2
C16831
Date of bone x-rays
Description

BoneX-RayAssessmentDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C25367
NCI Thesaurus ObjectClass
C12366
UMLS 2011AA ObjectClass
C0262950
NCI Thesaurus ObjectClass-2
C17261
Date Abdominal CT or MRI
Description

AbdominalCavityComputedTomographyMagneticResonanceImagingDiagnosticImagingPerformedDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C16502
NCI Thesaurus ObjectClass-2
C17204
NCI Thesaurus ObjectClass-3
C12664
NCI Thesaurus ObjectClass-4
C16809
NCI Thesaurus Property
C38000
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C0230168
UMLS CUI-2
C0040405
UMLS CUI-3
C0024485
UMLS CUI-4
C0011008
Date of liver CT or US scan
Description

LiverComputedTomographyUltrasoundImagingDiagnosticImagingPerformedDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C16502
NCI Thesaurus ObjectClass-2
C17204
NCI Thesaurus ObjectClass-3
C12392
NCI Thesaurus ObjectClass-4
C17230
NCI Thesaurus Property
C38000
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C0023884
UMLS CUI-2
C0040405
UMLS CUI-3
C0041618
UMLS CUI-4
C0011008
Abdominal ultrasound date
Description

AbdominalCavityUltrasoundImagingDiagnosticImagingPerformedDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C16502
NCI Thesaurus ObjectClass-2
C12664
NCI Thesaurus ObjectClass-3
C17230
NCI Thesaurus Property
C38000
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C2348813
UMLS CUI-2
C0011008
Eligibility Labs
Description

Eligibility Labs

Hemoglobin
Description

Hemoglobin

Data type

float

Measurement units
  • g/dL
Alias
NCI Thesaurus Property
C16676
NCI Thesaurus Property-2
C20200
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus ValueDomain
C25712
UMLS CUI [1]
C0019046
g/dL
Date
Description

Assessment Date

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C2985720
NCI Thesaurus ObjectClass
C25367
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus Property
C38000
Peripheral Platelet Count
Description

Peripheral Platelet Count

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
WBC
Description

WBC

Data type

float

Measurement units
  • /ul
Alias
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus Property
C12529
NCI Thesaurus Property-2
C20200
NCI Thesaurus ValueDomain
C38046
NCI Thesaurus ValueDomain-2
C25712
UMLS CUI [1]
C0023508
/ul
Granulocytes
Description

Granulocyte count

Data type

float

Measurement units
  • 1000/uL
Alias
NCI Thesaurus Property
C20200
UMLS CUI-1
C0857490
NCI Thesaurus Property-2
C12530
NCI Thesaurus ValueDomain
C25463
NCI Thesaurus ObjectClass
C25294
1000/uL
Mean Corpuscular Volume
Description

HematologyErythrocyteMeanCorpuscularVolumeLaboratoryUnspecifiedValue

Data type

float

Alias
NCI Thesaurus ObjectClass
C16673
NCI Thesaurus Property
C37984
NCI Thesaurus ValueDomain
C25712
NCI Thesaurus Property-2
C64799
UMLS CUI-1
C0524587
AST (SGOT)
Description

AST (SGOT)

Data type

float

Measurement units
  • U/L
Alias
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus Property
C25202
NCI Thesaurus Property-2
C20200
NCI Thesaurus ValueDomain
C38046
NCI Thesaurus ValueDomain-2
C25712
UMLS CUI [1]
C0201899
U/L
AST (SGOT) ULN
Description

AST (SGOT) ULN

Data type

float

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

ALT (SGPT)

Data type

float

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

ALT (SGPT) ULN

Data type

float

Measurement units
  • U/L
Alias
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus Property
C20200
NCI Thesaurus Property-2
C25293
NCI Thesaurus ValueDomain
C25712
NCI Thesaurus ValueDomain-2
C25706
UMLS CUI [1,1]
C0376147
UMLS CUI [1,2]
C1519815
U/L
Alkaline Phosphatase
Description

Alkaline Phosphatase

Data type

float

Measurement units
  • U/L
Alias
NCI Thesaurus Property
C20200
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus ValueDomain
C25712
NCI Thesaurus Property-2
C16276
UMLS CUI [1]
C0201850
U/L
Alkaline Phosphatase ULN
Description

Alkaline Phosphatase ULN

Data type

float

Measurement units
  • U/L
Alias
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus Property
C20200
NCI Thesaurus Property-2
C16276
NCI Thesaurus ValueDomain
C25712
NCI Thesaurus ValueDomain-2
C25706
UMLS CUI [1,1]
C0151420
UMLS CUI [1,2]
C1519815
U/L
Creatinine
Description

Creatinine

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
Serum Creatinine ULN
Description

Creatinine, serum ULN

Data type

float

Measurement units
  • mg/dL
Alias
NCI Thesaurus ObjectClass
C25294
UMLS CUI-1
C0201976
NCI Thesaurus Property
C20200
UMLS CUI-2
C1519815
NCI Thesaurus Property-2
C399
NCI Thesaurus ValueDomain
C25712
NCI Thesaurus ValueDomain-2
C25706
mg/dL
Bilirubin, total
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
Ineligibility Criteria
Description

Ineligibility Criteria

Fasting glucose
Description

LaboratoryProcedureFastingPlasmaGlucoseMeasurementOutcomeValue

Data type

float

Measurement units
  • mg/dL
Alias
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus Property
C20200
NCI Thesaurus Property-2
C41376
NCI Thesaurus Property-3
C63663
NCI Thesaurus ValueDomain
C25712
UMLS CUI-1
C0202045
mg/dL
Pregnancy Test Result
Description

LaboratoryProcedurePregnancyResultInd

Data type

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C25742
UMLS 2011AA Property-2
C0032961
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
Date of pregnancy test
Description

PatientMostRecentPregnancyTestDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Metathesaurus Property
C0032976
NCI Thesaurus Property
C25577
UMLS 2011AA Property
C1513491
Physical Exam
Description

Physical Exam

Date of Pre-entry History & Physical Exam
Description

PersonalMedicalHistoryPhysicalExaminationPerformedDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ObjectClass
C20989
NCI Thesaurus Property
C38000
NCI Thesaurus ObjectClass-2
C18772
UMLS CUI-1
C0150618
UMLS CUI-2
C0011008
Height
Description

Height

Data type

float

Measurement units
  • cm
Alias
NCI Thesaurus ValueDomain
C25209
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25347
UMLS CUI [1]
C0005890
cm
Body weight
Description

Body weight

Data type

float

Measurement units
  • kg
Alias
NCI Thesaurus ValueDomain
C25209
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25208
UMLS CUI [1]
C0005910
kg
Body Mass Index
Description

Body Mass Index (BMI)

Data type

float

Measurement units
  • kg/m2
Alias
NCI Thesaurus ObjectClass
C25190
NCI Thesaurus ValueDomain
C25712
NCI Thesaurus Property
C16358
NCI Thesaurus ValueDomain-2
C16358
UMLS CUI [1]
C1305855
kg/m2
Waist Circumference
Description

WaistCircumferenceMeasurementNumber3CharactersNoDecimal

Data type

float

Measurement units
  • %
Alias
NCI Thesaurus ValueDomain
C25337
NCI Thesaurus Property
C25209
NCI Metathesaurus ObjectClass
C0332520
NCI Thesaurus ObjectClass
C64192
UMLS CUI-1
C0455829
%
Hip Circumference
Description

HipCircumferenceMeasurementNumbers3NoDecimal

Data type

float

Measurement units
  • %
Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus Property
C25209
UMLS 2011AA Property
C0242485
NCI Metathesaurus ObjectClass
C0019552
NCI Metathesaurus ObjectClass-2
C0332520
%
Systolic
Description

Systolic

Data type

integer

Measurement units
  • mmHg
Alias
NCI Thesaurus ValueDomain
C25209
NCI Thesaurus Property
C25214
NCI Thesaurus ObjectClass
C25298
UMLS CUI [1]
C0871470
mmHg
Diastolic
Description

Diastolic

Data type

integer

Measurement units
  • mmHg
Alias
NCI Thesaurus ValueDomain
C25209
NCI Thesaurus Property
C25214
NCI Thesaurus ObjectClass
C25299
UMLS CUI [1]
C0428883
mmHg
Date of last menstrual period
Description

LastMenstrualCycleOccurrenceDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C25551
UMLS 2011AA ObjectClass
C1517741
NCI Thesaurus Property
C25275
UMLS 2011AA Property
C2745955
NCI Thesaurus ObjectClass-2
C16838
UMLS 2011AA ObjectClass-2
C0025329
Menopausal Status
Description

PatientMenopauseCategory

Data type

text

Alias
NCI Thesaurus ValueDomain
C25372
UMLS 2011AA ValueDomain
C0683312
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C3231
UMLS 2011AA Property
C0025320
NCI Thesaurus ValueDomain-2
C3231
UMLS 2011AA ValueDomain-2
C0025320
Stratification
Description

Stratification

Hormonal status
Description

PersonHormoneReceptorStatus

Data type

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus ValueDomain
C25688
UMLS 2011AA ValueDomain
C0449438
NCI Thesaurus Property
C28154
UMLS 2011AA Property
C0019929
NCI Thesaurus Property-2
C25365
UMLS 2011AA Property-2
C0678257
Body Mass Index
Description

PersonBodyMassIndexType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C16358
UMLS 2011AA Property
C1305855
Consent
Description

Consent

Has this subject given written consent to participate in MA.32F
Description

ParticipatingPatientAncillaryStudyConsentInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ObjectClass-2
C25608
UMLS 2011AA ObjectClass-2
C0679823
NCI Thesaurus Property
C25460
UMLS 2011AA Property
C1511481
NCI Metathesaurus Property
CL004903
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Has informed consent been signed and dated by patient and person conducting consent form discussion
Description

ConsentFormPatientResponsiblePersonSignedInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C16468
UMLS 2011AA ObjectClass
C0009797
NCI Thesaurus Property
C16960
UMLS 2011AA Property
C0030705
NCI Thesaurus Property-2
C25657
UMLS 2011AA Property-2
C1273518
NCI Thesaurus Property-3
C25679
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Consent form language
Description

ConsentFormLanguageType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C16468
UMLS 2011AA ObjectClass
C0009797
NCI Thesaurus Property
C16779
UMLS 2011AA Property
C0023008
Consent form version date
Description

InformedConsentFormVersionSignedDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C16468
UMLS 2011AA ObjectClass
C0009797
NCI Thesaurus Property
C25679
NCI Thesaurus Property-2
C25714
UMLS 2011AA Property
C0333052
Date signed by patient
Description

ConsentFormPatientVersionSignedDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C16468
UMLS 2011AA ObjectClass
C0009797
NCI Thesaurus Property
C16960
UMLS 2011AA Property
C0030705
NCI Thesaurus Property-2
C25679
NCI Thesaurus Property-3
C25714
UMLS 2011AA Property-2
C0333052
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Name of person conducting the consent form discussion
Description

ConsentFormPatientResponsiblePersonSignedName

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus Property
C16960
UMLS 2011AA Property
C0030705
NCI Thesaurus Property-2
C25657
UMLS 2011AA Property-2
C1273518
NCI Thesaurus ObjectClass
C16468
UMLS 2011AA ObjectClass
C0009797
NCI Thesaurus Property-3
C25679
Date of signature
Description

Investigator Signature Date

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C2346576
NCI Thesaurus Property
C25678
UMLS CUI-2
C0011008
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus ObjectClass
C17089
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  1. StudyEvent: NCIC MA.32 Eligibility Worksheet
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Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header Module
Institution Number
Item
Institution Code
text
C25337 (NCI Thesaurus ValueDomain)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass)
C0805701 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
Patient Initials
Item
Patient Initials
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Medical Record Number
Item
Hospital Number (if permitted by REB)
text
C25337 (NCI Thesaurus ValueDomain)
C1301894 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25261 (NCI Thesaurus Property)
C25198 (NCI Thesaurus Property-2)
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.3
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
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
CL Item
Veterans Sponsored (Veterans Sponsored)
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 Group
Patient Characteristics
Item
Patient Race
text
C25372 (NCI Thesaurus ValueDomain)
C0034510 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C17049 (NCI Thesaurus Property)
CL.1
Code List
Patient Race
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
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 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 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
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
Patient Ethnicity
text
C25372 (NCI Thesaurus ValueDomain)
C0015031 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C16564 (NCI Thesaurus Property)
CL.2
Code List
Patient 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)
CL Item
Could Not Be Determined Or Unsure (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item Group
Eligibility Criteria
InvasiveBreastCarcinomaHistologicallyConfirmedInd-2
Item
Subject has histologically confirmed invasive breast cancer that has been diagnosed and completely resected within 12 months prior to randomization
boolean
C4872 (NCI Thesaurus ObjectClass)
C0678222 (UMLS 2011AA ObjectClass)
C14159 (NCI Thesaurus ObjectClass-2)
C0205281 (UMLS 2011AA ObjectClass-2)
C25527 (NCI Thesaurus ObjectClass-3)
C0205462 (UMLS 2011AA ObjectClass-3)
C25458 (NCI Thesaurus Property)
C0750484 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Item
Tumor Laterality
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25251 (NCI Thesaurus ObjectClass-2)
C0205225 (UMLS 2011AA ObjectClass-2)
C25185 (NCI Thesaurus Property)
C0332304 (UMLS 2011AA Property)
CL.5
Code List
Tumor Laterality
CL Item
Left (Left)
C25229 (NCI Thesaurus)
C0205091 (UMLS 2011AA)
CL Item
Right (Right)
C25228 (NCI Thesaurus)
C0205090 (UMLS 2011AA)
CL Item
Bilateral (Bilateral)
C13332 (NCI Thesaurus)
C0238767 (UMLS 2011AA)
FirstBiopsyPositiveDate
Item
Date of Initial Diagnosis of Primary Tumor
date
C15189 (NCI Thesaurus ObjectClass)
C0005558 (UMLS 2011AA ObjectClass)
C25509 (NCI Thesaurus ObjectClass-2)
C1279901 (UMLS 2011AA ObjectClass-2)
C25246 (NCI Thesaurus Property)
C1446409 (UMLS 2011AA Property)
C25275 (NCI Thesaurus Property-2)
C2745955 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
Item
Histologic Type
text
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12971 (NCI Thesaurus ObjectClass-2)
C0006141 (UMLS 2011AA ObjectClass-2)
C25526 (NCI Thesaurus Property)
C0205462 (UMLS 2011AA Property)
C25161 (NCI Thesaurus Property-2)
C0008902 (UMLS 2011AA Property-2)
C25372 (NCI Thesaurus ValueDomain)
C0683312 (UMLS 2011AA ValueDomain)
C25526 (NCI Thesaurus ValueDomain-2)
C0205462 (UMLS 2011AA ValueDomain-2)
CL.6
Code List
Histologic Type
CL Item
Ductal (Ductal)
C25732 (NCI Thesaurus)
C1512083 (UMLS 2011AA)
CL Item
Lobular (Lobular)
C25557 (NCI Thesaurus)
C0205417 (UMLS 2011AA)
C25557 (NCI Thesaurus-3)
C0205417 (UMLS 2011AA-4)
Item
Most extensive definitive surgery
text
C25251 (NCI Thesaurus ObjectClass)
C0205225 (UMLS 2011AA ObjectClass)
C12971 (NCI Thesaurus ObjectClass-2)
C0006141 (UMLS 2011AA ObjectClass-2)
C15329 (NCI Thesaurus ObjectClass-3)
C0543467 (UMLS 2011AA ObjectClass-3)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.7
Code List
Most extensive definitive surgery
CL Item
Partial Mastectomy, Lumpectomy Or Excisional Biopsy (Partial mastectomy/lumpectomy/excisional biopsy)
CL Item
Mastectomy, Nos (Mastectomy NOS)
PrimarySurgeryDate
Item
Date of Most Extensive Primary Surgery
date
C25251 (NCI Thesaurus ObjectClass)
C0205225 (UMLS 2011AA ObjectClass)
C15329 (NCI Thesaurus ObjectClass-2)
C0543467 (UMLS 2011AA ObjectClass-2)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
Item
Is invasive cancer at margin?
text
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C14159 (NCI Thesaurus ObjectClass-2)
C0205281 (UMLS 2011AA ObjectClass-2)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C41227 (NCI Thesaurus Property-2)
C0229985 (UMLS 2011AA Property-2)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.8
Code List
Is invasive cancer at margin?
CL Item
Involved, Nos (Involved NOS)
CL Item
Not Involved, Nos (Not involved NOS)
DCISDiagnosisInd-3
Item
Is DCIS present? (at resection margin)
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C2924 (NCI Thesaurus ObjectClass)
C0007124 (UMLS 2011AA ObjectClass)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
AdjuvantRadiationTherapyAdministeredInd-3
Item
Has the subject received adjuvant radiotherapy
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C2140 (NCI Thesaurus ObjectClass-2)
C0001552 (UMLS 2011AA ObjectClass-2)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
RadiationTherapyBoostAdministeredind-2
Item
Was a boost given? (to the site of residual ductal in situ disease)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25438 (NCI Thesaurus Property-2)
C1511253 (UMLS 2011AA Property-2)
Item
If neoadjuvant, subject has no evidence of clinical T4 disease prior to chemotherapy and surgery
text
C16960 (NCI Thesaurus ObjectClass)
C15665 (NCI Thesaurus ObjectClass-2)
C2991 (NCI Thesaurus Property)
C25171 (NCI Thesaurus Property-2)
C49486 (NCI Thesaurus ValueDomain)
CL.12
Code List
If neoadjuvant, subject has no evidence of clinical T4 disease prior to chemotherapy and surgery
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Not Applicable (Not Applicable)
C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)
Item
T Stage, Clinical
text
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12971 (NCI Thesaurus ObjectClass-2)
C0006141 (UMLS 2011AA ObjectClass-2)
C25398 (NCI Thesaurus Property)
C0205210 (UMLS 2011AA Property)
C25728 (NCI Thesaurus Property-2)
C0475455 (UMLS 2011AA Property-2)
C16899 (NCI Thesaurus ValueDomain)
C1300072 (UMLS 2011AA ValueDomain)
CL.13
Code List
T Stage, Clinical
CL Item
Tumor 2 Cm Or Less In Greatest Dimension (T1)
CL Item
Tumor More Than 2 Cm But Not More Than 5 Cm In Greatest Dimension (T2)
CL Item
Tumor More Than 5 Cm In Greatest Dimension (T3)
CL Item
Tumor Of Any Size With Direct (T4)
Item
N Stage, Clinical
text
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12971 (NCI Thesaurus ObjectClass-2)
C0006141 (UMLS 2011AA ObjectClass-2)
C25398 (NCI Thesaurus Property)
C0205210 (UMLS 2011AA Property)
C25580 (NCI Thesaurus Property-2)
C0456532 (UMLS 2011AA Property-2)
C16899 (NCI Thesaurus ValueDomain)
C1300072 (UMLS 2011AA ValueDomain)
CL.14
Code List
N Stage, Clinical
CL Item
No Regional Lymph Node Metastasis (N0)
CL Item
Metastasis To Movable Ipsilateral Axillary Lymph Node(s) (N1)
CL Item
Metastasis To Ipsilateral Axillary Lymph Node(s) Fixed Or Matted, Or In Clinically Apparent* Ipsilateral Internal Mammary Nodes In The Absence Of Clinically Evident Lymph Node Metastasis (N2)
CL Item
Metastasis In Ipsilateral Infraclavicular Lymph Node(s) With Or Without Axillary Lymph Node Involvement, Or In Clinically Apparent* Ipsilateral Internal Mammary Lymph Node(s) And In The Presence Of Clinically Evident Axillary Lymph Node Metastasis; Or, Me (N3)
Item
M Stage, Clinical
text
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12971 (NCI Thesaurus ObjectClass-2)
C0006141 (UMLS 2011AA ObjectClass-2)
C25398 (NCI Thesaurus Property)
C0205210 (UMLS 2011AA Property)
C25727 (NCI Thesaurus Property-2)
C0456533 (UMLS 2011AA Property-2)
C16899 (NCI Thesaurus ValueDomain)
C1300072 (UMLS 2011AA ValueDomain)
CL.15
Code List
M Stage, Clinical
CL Item
No Distant Metastases (M0)
CL Item
Distant Metastasis (M1)
C18206 (NCI Thesaurus)
C1269798 (UMLS 2011AA)
CL Item
Distant Metastasis Cannot Be Assessed (MX)
T1-3 and M0
Item
Subject's TNM Stage (AJCC Version 6) is one of pT1, pT2, pT3; pN0, pN1, pN2, pN3; M0 and subject has one of the pT pN combinations described in protocol section 5.1.4 and subject has sentinel node biopsy and/or full axillary lymph node dissection
boolean
C38147 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C25171 (NCI Thesaurus Property)
C25384 (NCI Thesaurus Property-2)
Item
Pathologic T Stage
text
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12971 (NCI Thesaurus ObjectClass-2)
C0006141 (UMLS 2011AA ObjectClass-2)
C25610 (NCI Thesaurus Property)
C1521733 (UMLS 2011AA Property)
C25728 (NCI Thesaurus Property-2)
C0475455 (UMLS 2011AA Property-2)
C16899 (NCI Thesaurus ValueDomain)
C1300072 (UMLS 2011AA ValueDomain)
CL.17
Code List
Pathologic T Stage
CL Item
No Evidence Of Primary Tumor (T0)
CL Item
Tumor 2 Cm Or Less In Greatest Dimension (T1)
CL Item
Tumor More Than 0.1 Cm But Not More Than 0.5 Cm In Greatest Dimension (T1a)
CL Item
Tumor More Than 0.5 Cm But Not More Than 1 Cm In Greatest Dimension (T1b)
CL Item
Tumor More Than 1 Cm But Not More Than 2 Cm In Greatest Dimension (T1c)
CL Item
Microinvasion 0.1 Cm Or Less In Greatest Dimension (T1mic)
CL Item
Tumor More Than 2 Cm But Not More Than 5 Cm In Greatest Dimension (T2)
CL Item
Tumor More Than 5 Cm In Greatest Dimension (T3)
CL Item
Tumor Of Any Size With Direct (T4)
CL Item
Extension To Chest Wall (T4a)
CL Item
Edema (including Peau D'orange) Or Ulceration Of The Skin Of The Breast Or Satellite Skin Nodules Confined To The Same Breast (T4b)
CL Item
Both T4a And T4b (T4c)
CL Item
Inflammatory Carcinoma (T4d)
C0334385 (NCI Metathesaurus)
CL Item
Carcinoma In Situ: Intraductal Carcinoma, Lobular Carcinoma In Situ, Or Paget's Disease Of The Nipple With No Tumor (Tis)
CL Item
Ductal Carcinoma In Situ (Tis (DCIS))
CL Item
Lobular Carcinoma In Situ (Tis (LCIS))
CL Item
Paget's Disease Of The Nipple With No Tumor. [note: Paget's Disease Associated With A Tumor Is Classified According To The Size Of The Tumor.] (Tis (Paget's))
CL Item
Primary Tumor Cannot Be Assessed (TX)
Item
Pathologic N Stage
text
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12971 (NCI Thesaurus ObjectClass-2)
C0006141 (UMLS 2011AA ObjectClass-2)
C25610 (NCI Thesaurus Property)
C1521733 (UMLS 2011AA Property)
C25580 (NCI Thesaurus Property-2)
C0456532 (UMLS 2011AA Property-2)
C16899 (NCI Thesaurus ValueDomain)
C1300072 (UMLS 2011AA ValueDomain)
CL.18
Code List
Pathologic N Stage
CL Item
No Regional Lymph Node Metastasis Histologically, No Additional Examination For Isolated Tumor Cells (itc) (pN0)
CL Item
No Regional Lymph Node Metastasis Histologically, Positive Ihc, No Ihc Cluster >0.2 Mm (pN0(i+))
CL Item
No Regional Lymph Node Metastasis Histologically, Negative Ihc (pN0(i-))
CL Item
No Regionally Lymph Node Metastasis Histologically, Positive Molecular Findings (rt-pcr) (pN0(mol+))
CL Item
No Regional Lymph Node Metastasis Histologically, Negative Molecular Findings (rt-pcr) (pN0(mol-))
CL Item
Metastasis In 1 To 3 Axillary Lymph Nodes, And/or In Internal Mammary Nodes With Microscopic Disease Detected By Sln Dissection But Not Clinically Apparent (pN1)
CL Item
Metastasis In 1 To 3 Axillary Lymph Nodes (pN1a)
CL Item
Metastasis In Internal Mammary Nodes With Microscopic Disease Detected By Sln Dissection But Not Clinically Apparent (pN1b)
CL Item
Metastasis In 1 To 3 Axillary Lymph Nodes And In Internal Mammary Lymph Nodes With Microscopic Disease Detected By Sln Dissection But Not Clinically Apparent. (pN1c)
CL Item
Micrometastasis (>0.2 Mm But <=2.0 Mm) (pN1mi)
CL Item
Metastasis In 4 To 9 Axillary Lymph Nodes, Or In Clinically Apparent ** Internal Mammary Lymph Nodes In The Absence Of Axillary Lymph Node Metastasis To Ipsilateral Axillary Lymph Node(s) Fixed To Each Other Or To Other Structures (pN2)
CL Item
Metastasis In 4 To 9 Axillary Lymph Nodes (at Least 1 Tumor Deposit >2.0 Mm) (pN2a)
CL Item
Metastasis In Clinically Apparent* Internal Mammary Lymph Nodes In The Absence Of Axillary Lymph Node Metastasis (pN2b)
CL Item
Metastasis In >= Axillary Lymph Nodes, Or In Infraclavicular Lymph Nodes, Or In Clinically Apparent* Ipsilateral Internal Mammary Lymph Node(s) In The Presence Of 1 Or More Positive Axillary Lymph Node(s); Or, In >3 Axillary Lymph Nodes With Clinically N (pN3)
CL Item
Metastasis In >=10 Axillary Lymph Nodes (at Least 1 Tumor Deposit >2.0 Mm); Or, Metastasis To The Infraclavicular Lymph Nodes (pN3a)
CL Item
Metastasis In Clinically Apparent* Ipsilateral Internal Mammary Lymph Nodes In The Presence Of >=1 Positive Axillary Lymph Node(s); Or, In >3 Axillary Lymph Nodes And In Internal Mammary Lymph Nodes With Microscopic Disease Detected By Sentinel Lymph Node (pN3b)
CL Item
Metastasis In Ipsilateral Supraclavicular Lymph Nodes (pN3c)
CL Item
Regional Lymph Nodes Cannot Be Assessed (e.g., Not Removed For Pathologic Study Or Previously Removed) (pNX)
Item
Pathologic M Stage
text
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12971 (NCI Thesaurus ObjectClass-2)
C0006141 (UMLS 2011AA ObjectClass-2)
C25610 (NCI Thesaurus Property)
C1521733 (UMLS 2011AA Property)
C25727 (NCI Thesaurus Property-2)
C0456533 (UMLS 2011AA Property-2)
C16899 (NCI Thesaurus ValueDomain)
C1300072 (UMLS 2011AA ValueDomain)
CL.19
Code List
Pathologic M Stage
CL Item
No Distant Metastasis (M0)
CL Item
Distant Metastasis (M1)
C18206 (NCI Thesaurus)
C1269798 (UMLS 2011AA)
CL Item
Distant Metastasis Cannot Be Assessed (MX)
Item
Histologic Grade
text
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12971 (NCI Thesaurus ObjectClass-2)
C0006141 (UMLS 2011AA ObjectClass-2)
C25526 (NCI Thesaurus Property)
C0205462 (UMLS 2011AA Property)
C25365 (NCI Thesaurus Property-2)
C0678257 (UMLS 2011AA Property-2)
C25526 (NCI Thesaurus ValueDomain)
C0205462 (UMLS 2011AA ValueDomain)
C18000 (NCI Thesaurus ValueDomain-2)
C0919553 (UMLS 2011AA ValueDomain-2)
CL.20
Code List
Histologic Grade
CL Item
G1 Low Combined Histologic Grade (favorable) (G1)
CL Item
G2 Intermediate Combined Histologic Grade (moderately Favorable) (G2)
CL Item
G3 High Combined Histologic Grade (unfavorable) (G3)
CL Item
Gx Grade Cannot Be Assessed (GX)
Item
Is there lymphovascular invasion?
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C20625 (NCI Thesaurus Property)
C1269955 (UMLS 2011AA Property)
C25561 (NCI Thesaurus Property-2)
C1518090 (UMLS 2011AA Property-2)
CL.21
Code List
Is there lymphovascular invasion?
CL Item
Yes (YES)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (NO)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Unknown (UNKNOWN)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
LaboratoryProcedureOncotypeDXBreastCancerAssayResultScore
Item
Oncotype DX Recurrence Score
float
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C52159 (NCI Thesaurus Property-2)
C1709318 (UMLS 2011AA Property-2)
C25338 (NCI Thesaurus ValueDomain)
C0449820 (UMLS 2011AA ValueDomain)
LaboratoryProcedureTumorMarkerKi-67AntigenResultValue
Item
Ki67 Score
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C17220 (NCI Thesaurus Property-2)
C0041365 (UMLS 2011AA Property-2)
C17675 (NCI Thesaurus Property-3)
C0208804 (UMLS 2011AA Property-3)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
SentinelNodeBiopsyInd-3
Item
Was sentinel node sampling performed
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15189 (NCI Thesaurus Property)
C0005558 (UMLS 2011AA Property)
C12947 (NCI Thesaurus ObjectClass)
C1522495 (UMLS 2011AA ObjectClass)
SentinelNodeBiopsyDate
Item
Sentinel Node Biopsy Date
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
C15189 (NCI Thesaurus Property)
C0005558 (UMLS 2011AA Property)
C12947 (NCI Thesaurus ObjectClass)
C1522495 (UMLS 2011AA ObjectClass)
SentinelNodeExaminedCount
Item
Number of Sentinel Nodes Examined
float
C25500 (NCI Thesaurus Property)
C0332128 (UMLS 2011AA Property)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
C12947 (NCI Thesaurus ObjectClass)
C1522495 (UMLS 2011AA ObjectClass)
SentinelNodePositiveAssessmentCount
Item
Number of Positive Sentinel Nodes
float
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C0205159 (NCI Metathesaurus Property)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
C12947 (NCI Thesaurus ObjectClass)
C1522495 (UMLS 2011AA ObjectClass)
AxillaryNodeDissectionInd-3
Item
Was axillary dissection performed?
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15227 (NCI Thesaurus Property)
C0012737 (UMLS 2011AA Property)
C12904 (NCI Thesaurus ObjectClass)
C0729594 (UMLS 2011AA ObjectClass)
Date of Axillary Node Biopsy
Item
Date of Axillary Node Biopsy
date
C15680 (NCI Thesaurus ObjectClass)
C15361 (NCI Thesaurus ObjectClass-2)
C51900 (NCI Thesaurus ObjectClass-3)
C12904 (NCI Thesaurus ObjectClass-4)
C38000 (NCI Thesaurus Property)
C25629 (NCI Thesaurus Property-2)
C15206 (NCI Thesaurus Property-3)
C25164 (NCI Thesaurus ValueDomain)
C0193842 (UMLS CUI-1)
C0729594 (UMLS CUI-2)
C0011008 (UMLS CUI-3)
AxillaryNodeExaminedTotalCount
Item
Number of axillary nodes examined
float
C25304 (NCI Thesaurus ValueDomain)
C0439810 (UMLS 2011AA ValueDomain)
C25500 (NCI Thesaurus Property)
C0332128 (UMLS 2011AA Property)
C25463 (NCI Thesaurus ValueDomain-2)
C0750480 (UMLS 2011AA ValueDomain-2)
C12904 (NCI Thesaurus ObjectClass)
C0729594 (UMLS 2011AA ObjectClass)
PositiveAxillaryNodeExaminedTotalCount
Item
Number of positive axillary nodes
float
C25246 (NCI Thesaurus ObjectClass)
C1446409 (UMLS 2011AA ObjectClass)
C12904 (NCI Thesaurus ObjectClass-2)
C0729594 (UMLS 2011AA ObjectClass-2)
C25500 (NCI Thesaurus Property)
C0332128 (UMLS 2011AA Property)
C25304 (NCI Thesaurus ValueDomain)
C0439810 (UMLS 2011AA ValueDomain)
C25463 (NCI Thesaurus ValueDomain-2)
C0750480 (UMLS 2011AA ValueDomain-2)
LymphNodeExaminedCount
Item
Number of Lymph Nodes Examined
float
C25500 (NCI Thesaurus Property)
C0332128 (UMLS 2011AA Property)
C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
LymphNodePositiveCount
Item
Number of Positive Lymph Nodes
float
C25246 (NCI Thesaurus Property)
C1446409 (UMLS 2011AA Property)
C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
Item
If subject has bilateral breast carcinoma diagnoses were synchronous - within 3 months of one another - and at least one of the two breast carcinomas meet the eligibility criteria and neither meets the exclusion criteria
text
C16960 (NCI Thesaurus ObjectClass)
C13332 (NCI Thesaurus Property)
C4872 (NCI Thesaurus Property-2)
C25171 (NCI Thesaurus Property-3)
C49486 (NCI Thesaurus ValueDomain)
C0238767 (UMLS CUI-1)
C0678222 (UMLS CUI-2)
CL.24
Code List
If subject has bilateral breast carcinoma diagnoses were synchronous - within 3 months of one another - and at least one of the two breast carcinomas meet the eligibility criteria and neither meets the exclusion criteria
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Not Applicable (Not Applicable)
C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)
Item
Chemotherapy, if given, has been completed at least 4 weeks prior to randomization
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C15632 (NCI Thesaurus Property)
C0392920 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property-2)
C0013893 (UMLS 2011AA Property-2)
C49486 (NCI Thesaurus ValueDomain)
C1704854 (UMLS 2011AA ValueDomain)
CL.25
Code List
Chemotherapy, if given, has been completed at least 4 weeks prior to randomization
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
Not Applicable (Not Applicable)
C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)
CL Item
Not Applicable (Not Applicable)
C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)
PriorAdjuvantChemotherapyAdministeredInd-2
Item
Prior Adjuvant Chemotherapy
boolean
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C2140 (NCI Thesaurus ObjectClass-3)
C0001552 (UMLS 2011AA ObjectClass-3)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
AdjuvantChemotherapyPriorEndDate
Item
Date Prior Adjuvant Chemotherapy Ended
date
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C2140 (NCI Thesaurus ObjectClass-2)
C0001552 (UMLS 2011AA ObjectClass-2)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C25275 (NCI Thesaurus Property-2)
C2745955 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
Known estrogen/progesterone receptor status
Item
Estrogen/progesterone receptor status is known
boolean
C16960 (NCI Thesaurus ObjectClass)
C25171 (NCI Thesaurus Property)
C16149 (NCI Thesaurus Property-2)
C16150 (NCI Thesaurus Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1514471 (UMLS CUI-1)
C1516974 (UMLS CUI-2)
Item
Receptor Status, ER
text
C3262 (NCI Thesaurus ValueDomain)
C0027651 (UMLS 2011AA ValueDomain)
C17069 (NCI Thesaurus ObjectClass)
C0034804 (UMLS 2011AA ObjectClass)
C25688 (NCI Thesaurus ValueDomain-2)
C0449438 (UMLS 2011AA ValueDomain-2)
C25554 (NCI Thesaurus Property)
C0441889 (UMLS 2011AA Property)
CL.28
Code List
Receptor Status, ER
CL Item
Positive (Positive)
C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)
CL Item
Negative (Negative)
C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)
Item
Receptor Status, PgR
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C17075 (NCI Thesaurus ObjectClass)
C0034833 (UMLS 2011AA ObjectClass)
C0678257 (NCI Metathesaurus Property)
CL.29
Code List
Receptor Status, PgR
CL Item
Positive (Positive)
C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)
CL Item
Negative (Negative)
C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
PatientHER2/neuEligibilityDeterminationInd-2
Item
HER2 status is known
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
C17756 (NCI Thesaurus Property-2)
C0242957 (UMLS 2011AA Property-2)
Item
HER-2/neu status
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C17756 (NCI Thesaurus ObjectClass)
C0242957 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
CL.53
Code List
HER-2/neu status
CL Item
Positive (Positive)
C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)
CL Item
Negative (Negative)
C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)
Item
HER2 test type
text
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C71460 (NCI Thesaurus Property)
C0025663 (UMLS 2011AA Property)
C17756 (NCI Thesaurus Property-2)
C0242957 (UMLS 2011AA Property-2)
C25688 (NCI Thesaurus Property-3)
C0449438 (UMLS 2011AA Property-3)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.32
Code List
HER2 test type
CL Item
Immunohistochemistry Staining Method (IHC)
C23020 (NCI Thesaurus)
C0021044 (UMLS 2011AA)
CL Item
Fluorescence In Situ Hybridization (FISH)
C17563 (NCI Thesaurus)
C0162789 (UMLS 2011AA)
CL Item
Chromogenic In Situ Hybridization (CISH)
C40960 (NCI Thesaurus)
C1516514 (UMLS 2011AA)
CL Item
Other (Other)
LaboratoryProcedureHER2/neuStatusMethodSpecify
Item
Specify (If other,)
text
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C71460 (NCI Thesaurus Property)
C0025663 (UMLS 2011AA Property)
C17756 (NCI Thesaurus Property-2)
C0242957 (UMLS 2011AA Property-2)
C25688 (NCI Thesaurus Property-3)
C0449438 (UMLS 2011AA Property-3)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
PatientBilateralMammogramEligibilityDeterminationInd-2
Item
Subject has had a bilateral mammogram within 12 months prior to randomization
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C20178 (NCI Thesaurus Property)
C0024671 (UMLS 2011AA Property)
C13332 (NCI Thesaurus Property-2)
C0238767 (UMLS 2011AA Property-2)
C25171 (NCI Thesaurus Property-3)
C0013893 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
MammogramPerformedDate
Item
Date of mammogram
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)
ECOG 0,1,2
Item
Subject has ECOG Performance Status of 0, 1 or 2
boolean
C38147 (NCI Thesaurus ValueDomain)
C20989 (NCI Thesaurus Property)
C25491 (NCI Thesaurus ObjectClass)
CL092952 (NCI Metathesaurus ObjectClass)
C1512162 (UMLS CUI-1)
Item
ECOG Performance Status
text
C25664 (NCI Thesaurus ValueDomain)
C1520224 (UMLS CUI-1)
C25367 (NCI Thesaurus Property)
C25491 (NCI Thesaurus ValueDomain-2)
C20641 (NCI Thesaurus ObjectClass)
CL.36
Code List
ECOG Performance Status
CL Item
Fully Active, Able To Carry On All Pre-disease Performance Without Restriction. (0)
CL Item
Restricted In Physically Strenuous Activity But Ambulatory And Able To Carry Out Work Of A Light Or Sedentary Nature, E.g., Light Housework, Office Work. (1)
CL Item
Ambulatory And Capable Of All Selfcare But Unable To Carry Out Any Work Activities. Up And About More Than 50% Of Waking Hours. (2)
CL Item
Capable Of Only Limited Selfcare, Confined To Bed Or Chair More Than 50% Of Waking Hours. (3)
CL Item
Completely Disabled. Cannot Carry On Any Selfcare. Totally Confined To Bed Or Chair. (4)
PatientAgeEligibilityDeterminationInd-2
Item
Subject is < 75 years of age and has life expectancy of at least 5 years
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25150 (NCI Thesaurus Property)
C0001779 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property-2)
C0013893 (UMLS 2011AA Property-2)
Birth date
Item
Patient date of birth
date
C25164 (NCI Thesaurus ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C25155 (NCI Thesaurus Property)
C0421451 (UMLS CUI [1])
Age
Item
Age
integer
C25337 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C25150 (NCI Thesaurus Property)
C0001779 (UMLS CUI [1])
Patient available for treatment and follow-up
Item
Subject is accessible for treatment and follow-up
boolean
C16960 (NCI Thesaurus ObjectClass)
C16033 (NCI Thesaurus Property)
C49236 (NCI Thesaurus Property-2)
C25171 (NCI Thesaurus Property-3)
C38147 (NCI Thesaurus ValueDomain)
TherapyBeginRequirementInd-2
Item
Protocol treatment will begin within 10 working days after randomization
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25431 (NCI Thesaurus Property)
C0439659 (UMLS 2011AA Property)
C38015 (NCI Thesaurus Property-2)
InformedConsentFormSignedInd-2
Item
Most recent REB approved informed consent has been signed according to local institutional requirements
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16468 (NCI Thesaurus ObjectClass)
C0009797 (UMLS 2011AA ObjectClass)
C25679 (NCI Thesaurus Property)
PatientCorrelativeStudySpecimenConsentInd-3
Item
Most recent REB approved Tissue and Blood Collection and Banking informed consent has been signed and dated by the patient and appropriate "I agree/I don't agree" box has been checked
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)
PatientCorrelativeStudySpecimenConsentDate
Item
Date tissue and blood collection and banking consent signed
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
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)
PatientCorrelativeStudySpecimenConsentVersionDate
Item
Tissue and blood collection and banking consent version date
text
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)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
English or French speaking
Item
Is the subject English or French speaking
boolean
C16960 (NCI Thesaurus ObjectClass)
C43853 (NCI Thesaurus Property)
C16779 (NCI Thesaurus Property-2)
C43854 (NCI Thesaurus Property-3)
C25171 (NCI Thesaurus Property-4)
C38147 (NCI Thesaurus ValueDomain)
C0745640 (UMLS CUI-1)
C0376246 (UMLS CUI-2)
Item
Subject has completed the baseline Quality of Life questionnaire and is willing to complete future assessments
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C17047 (NCI Thesaurus Property)
C0518214 (UMLS 2011AA Property)
C25250 (NCI Thesaurus Property-2)
C0205197 (UMLS 2011AA Property-2)
C25369 (NCI Thesaurus Property-3)
C0680240 (UMLS 2011AA Property-3)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
CL.43
Code List
Subject has completed the baseline Quality of Life questionnaire and is willing to complete future assessments
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
No, The Questionnaire Was Not Completed But For Reason(s) That Do Not Affect Eligibility (No, the questionnaire was not completed but for reason(s) that do not affect eligibility)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
QualityofLifeCompleteAssessmentDate
Item
Date Questionnaire Completed
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C17047 (NCI Thesaurus ObjectClass)
C0518214 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C25367 (NCI Thesaurus Property-2)
Item
Reason questionnaire was not completed
text
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C17048 (NCI Thesaurus Property-2)
C0034394 (UMLS 2011AA Property-2)
CL.48
Code List
Reason questionnaire was not completed
CL Item
Illiteracy In English (Illiteracy in English)
CL Item
Loss Of Sight (Loss of sight)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
PatientIncompleteQuestionnaireOtherSpecify
Item
Specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C17649 (NCI Thesaurus ValueDomain-2)
C0205394 (UMLS 2011AA ValueDomain-2)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C0034394 (NCI Metathesaurus Property)
PatientEnglishLanguageEligibilityDeterminationInd-2
Item
Is the subject English speaking and has s/he already completed the Quality of Life questionnaire
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C82847 (NCI Thesaurus Property)
C0376245 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property-2)
C0013893 (UMLS 2011AA Property-2)
Item
Subject has completed the baseline Nurses Health Study II Physical Activity Questionnaire and the Block Alive Screener and is willing to complete future assessments
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C19464 (NCI Thesaurus ObjectClass)
C0376315 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C25406 (NCI Thesaurus ObjectClass-2)
C1524062 (UMLS 2011AA ObjectClass-2)
CL.47
Code List
Subject has completed the baseline Nurses Health Study II Physical Activity Questionnaire and the Block Alive Screener and is willing to complete future assessments
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
No, The Questionnaire Was Not Completed But For Reason(s) That Do Not Affect Eligibility (No, the questionnaire was not completed but for reason(s) that do not affect eligibility)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
AdditionalFormCompleteDate
Item
Date patient filled out questionnaires
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C19464 (NCI Thesaurus ObjectClass)
C0376315 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C25406 (NCI Thesaurus ObjectClass-2)
C1524062 (UMLS 2011AA ObjectClass-2)
Investigations within 4 weeks to surgery
Item
Investigations, including chest X-ray or CT chest, bone scan and abdominal have been performed no earlier than 4 weeks prior to primary surgery and no later than the date of randomization and are negative for metastases
boolean
C25294 (NCI Thesaurus ObjectClass)
C38000 (NCI Thesaurus Property)
C25629 (NCI Thesaurus Property-2)
C49236 (NCI Thesaurus Property-3)
C38147 (NCI Thesaurus ValueDomain)
ChestX-RayAssessmentDate
Item
Date of Chest X-ray
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C25389 (NCI Thesaurus ObjectClass)
C0817096 (UMLS 2011AA ObjectClass)
C17261 (NCI Thesaurus ObjectClass-2)
Date of CT or MRI of chest
Item
Date of CT or MRI of chest
date
C16502 (NCI Thesaurus ObjectClass)
C17204 (NCI Thesaurus ObjectClass-2)
C25389 (NCI Thesaurus ObjectClass-3)
C16809 (NCI Thesaurus ObjectClass-4)
C38000 (NCI Thesaurus Property)
C25164 (NCI Thesaurus ValueDomain)
C0817096 (UMLS CUI-1)
C0040405 (UMLS CUI-2)
C0024485 (UMLS CUI-3)
C0011008 (UMLS CUI-4)
BoneScanMedicalImagingAssessmentDate
Item
Date of bone scan
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus Property)
C17646 (NCI Thesaurus ObjectClass)
C0203668 (UMLS 2011AA ObjectClass)
C16831 (NCI Thesaurus ObjectClass-2)
BoneX-RayAssessmentDate
Item
Date of bone x-rays
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus Property)
C12366 (NCI Thesaurus ObjectClass)
C0262950 (UMLS 2011AA ObjectClass)
C17261 (NCI Thesaurus ObjectClass-2)
Date Abdominal CT or MRI
Item
Date Abdominal CT or MRI
date
C16502 (NCI Thesaurus ObjectClass)
C17204 (NCI Thesaurus ObjectClass-2)
C12664 (NCI Thesaurus ObjectClass-3)
C16809 (NCI Thesaurus ObjectClass-4)
C38000 (NCI Thesaurus Property)
C25164 (NCI Thesaurus ValueDomain)
C0230168 (UMLS CUI-1)
C0040405 (UMLS CUI-2)
C0024485 (UMLS CUI-3)
C0011008 (UMLS CUI-4)
Date of liver CT or US scan
Item
Date of liver CT or US scan
date
C16502 (NCI Thesaurus ObjectClass)
C17204 (NCI Thesaurus ObjectClass-2)
C12392 (NCI Thesaurus ObjectClass-3)
C17230 (NCI Thesaurus ObjectClass-4)
C38000 (NCI Thesaurus Property)
C25164 (NCI Thesaurus ValueDomain)
C0023884 (UMLS CUI-1)
C0040405 (UMLS CUI-2)
C0041618 (UMLS CUI-3)
C0011008 (UMLS CUI-4)
Abdominal ultrasound date
Item
Abdominal ultrasound date
date
C16502 (NCI Thesaurus ObjectClass)
C12664 (NCI Thesaurus ObjectClass-2)
C17230 (NCI Thesaurus ObjectClass-3)
C38000 (NCI Thesaurus Property)
C25164 (NCI Thesaurus ValueDomain)
C2348813 (UMLS CUI-1)
C0011008 (UMLS CUI-2)
Item Group
Eligibility Labs
Hemoglobin
Item
Hemoglobin
float
C16676 (NCI Thesaurus Property)
C20200 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C0019046 (UMLS CUI [1])
Assessment Date
Item
Date
date
C25164 (NCI Thesaurus ValueDomain)
C2985720 (UMLS CUI-1)
C25367 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain-2)
C38000 (NCI Thesaurus Property)
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])
Leukocytes (WBC)
Item
WBC
float
C25294 (NCI Thesaurus ObjectClass)
C12529 (NCI Thesaurus Property)
C20200 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C0023508 (UMLS CUI [1])
Granulocyte count
Item
Granulocytes
float
C20200 (NCI Thesaurus Property)
C0857490 (UMLS CUI-1)
C12530 (NCI Thesaurus Property-2)
C25463 (NCI Thesaurus ValueDomain)
C25294 (NCI Thesaurus ObjectClass)
MCV
Item
Mean Corpuscular Volume
float
C16673 (NCI Thesaurus ObjectClass)
C37984 (NCI Thesaurus Property)
C25712 (NCI Thesaurus ValueDomain)
C64799 (NCI Thesaurus Property-2)
C0524587 (UMLS CUI-1)
AST
Item
AST (SGOT)
float
C25294 (NCI Thesaurus ObjectClass)
C25202 (NCI Thesaurus Property)
C20200 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C0201899 (UMLS CUI [1])
AST ULN
Item
AST (SGOT) ULN
float
C25294 (NCI Thesaurus ObjectClass)
C25202 (NCI Thesaurus Property)
C20200 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C0242192 (UMLS CUI [1,1])
C1519815 (UMLS CUI [1,2])
ALT
Item
ALT (SGPT)
float
C25294 (NCI Thesaurus ObjectClass)
C20200 (NCI Thesaurus Property)
C25293 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C0201836 (UMLS CUI [1])
ALT ULN
Item
ALT (SGPT) ULN
float
C25294 (NCI Thesaurus ObjectClass)
C20200 (NCI Thesaurus Property)
C25293 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C0376147 (UMLS CUI [1,1])
C1519815 (UMLS CUI [1,2])
Alkaline Phosphatase
Item
Alkaline Phosphatase
float
C20200 (NCI Thesaurus Property)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C16276 (NCI Thesaurus Property-2)
C0201850 (UMLS CUI [1])
Alkaline Phosphatase ULN
Item
Alkaline Phosphatase ULN
float
C25294 (NCI Thesaurus ObjectClass)
C20200 (NCI Thesaurus Property)
C16276 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C0151420 (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
Serum Creatinine ULN
float
C25294 (NCI Thesaurus ObjectClass)
C0201976 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C1519815 (UMLS CUI-2)
C399 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
Bilirubin, total
Item
Bilirubin, total
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])
Item Group
Ineligibility Criteria
Fasting glucose
Item
Fasting glucose
float
C25294 (NCI Thesaurus ObjectClass)
C20200 (NCI Thesaurus Property)
C41376 (NCI Thesaurus Property-2)
C63663 (NCI Thesaurus Property-3)
C25712 (NCI Thesaurus ValueDomain)
C0202045 (UMLS CUI-1)
Item
Pregnancy Test Result
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25742 (NCI Thesaurus Property-2)
C0032961 (UMLS 2011AA Property-2)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
CL.49
Code List
Pregnancy Test Result
CL Item
Negative (negative)
C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)
CL Item
Not Applicable, Not Female Of Child-bearing Potential (not applicable, not female of child-bearing potential)
CL Item
Positive (positive)
C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)
CL Item
Not Evaluated (not evaluated)
PatientMostRecentPregnancyTestDate
Item
Date of pregnancy test
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C0032976 (NCI Metathesaurus Property)
C25577 (NCI Thesaurus Property)
C1513491 (UMLS 2011AA Property)
Item Group
Physical Exam
History and physical examination date
Item
Date of Pre-entry History & Physical Exam
date
C25164 (NCI Thesaurus ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C38000 (NCI Thesaurus Property)
C18772 (NCI Thesaurus ObjectClass-2)
C0150618 (UMLS CUI-1)
C0011008 (UMLS CUI-2)
Height
Item
Height
float
C25209 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C25347 (NCI Thesaurus Property)
C0005890 (UMLS CUI [1])
Weight
Item
Body weight
float
C25209 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C25208 (NCI Thesaurus Property)
C0005910 (UMLS CUI [1])
BMI
Item
Body Mass Index
float
C25190 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C16358 (NCI Thesaurus Property)
C16358 (NCI Thesaurus ValueDomain-2)
C1305855 (UMLS CUI [1])
Waist Circumference
Item
Waist Circumference
float
C25337 (NCI Thesaurus ValueDomain)
C25209 (NCI Thesaurus Property)
C0332520 (NCI Metathesaurus ObjectClass)
C64192 (NCI Thesaurus ObjectClass)
C0455829 (UMLS CUI-1)
HipCircumferenceMeasurementNumbers3NoDecimal
Item
Hip Circumference
float
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25209 (NCI Thesaurus Property)
C0242485 (UMLS 2011AA Property)
C0019552 (NCI Metathesaurus ObjectClass)
C0332520 (NCI Metathesaurus ObjectClass-2)
Systolic blood pressure
Item
Systolic
integer
C25209 (NCI Thesaurus ValueDomain)
C25214 (NCI Thesaurus Property)
C25298 (NCI Thesaurus ObjectClass)
C0871470 (UMLS CUI [1])
Diastolic blood pressure
Item
Diastolic
integer
C25209 (NCI Thesaurus ValueDomain)
C25214 (NCI Thesaurus Property)
C25299 (NCI Thesaurus ObjectClass)
C0428883 (UMLS CUI [1])
LastMenstrualCycleOccurrenceDate
Item
Date of last menstrual period
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25551 (NCI Thesaurus ObjectClass)
C1517741 (UMLS 2011AA ObjectClass)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
C16838 (NCI Thesaurus ObjectClass-2)
C0025329 (UMLS 2011AA ObjectClass-2)
Item
Menopausal Status
text
C25372 (NCI Thesaurus ValueDomain)
C0683312 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C3231 (NCI Thesaurus Property)
C0025320 (UMLS 2011AA Property)
C3231 (NCI Thesaurus ValueDomain-2)
C0025320 (UMLS 2011AA ValueDomain-2)
CL.50
Code List
Menopausal Status
CL Item
Pre (<6 Mo Since Lmp And No Prior Bilateral Ovariectomy And Not On Estrogen Replacement) (Pre (<6 mo since LMP AND no prior bilateral ovariectomy AND not on estrogen replacement))
CL Item
Post (prior Bilateral Ovariectomy Or >12 Mo Since Lmp With No Prior Hysterectomy) (Post (prior bilateral ovariectomy OR >12 mo since LMP with no prior hysterectomy))
CL Item
Above Categories Not Applicable And Age <50 (Above categories not applicable AND Age < 50)
CL Item
Above Categories Not Applicable And Age >= 50 (Above categories not applicable AND Age >= 50)
Item Group
Stratification
Item
Hormonal status
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
C28154 (NCI Thesaurus Property)
C0019929 (UMLS 2011AA Property)
C25365 (NCI Thesaurus Property-2)
C0678257 (UMLS 2011AA Property-2)
CL.51
Code List
Hormonal status
CL Item
Er-positive And/or Pgr-positive (ER-positive and/or PgR-positive)
CL Item
Er-negative And Pgr Negative (neither Tamoxifen Nor Aromatase Inhibitor Is Permitted)) (ER-negative and PgR negative (neither tamoxifen nor aromatase inhibitor is permitted)))
Item
Body Mass Index
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C16358 (NCI Thesaurus Property)
C1305855 (UMLS 2011AA Property)
CL.52
Code List
Body Mass Index
CL Item
<=30 (<=30)
CL Item
>30 (>30)
Item Group
Consent
ParticipatingPatientAncillaryStudyConsentInd-2
Item
Has this subject given written consent to participate in MA.32F
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25608 (NCI Thesaurus ObjectClass-2)
C0679823 (UMLS 2011AA ObjectClass-2)
C25460 (NCI Thesaurus Property)
C1511481 (UMLS 2011AA Property)
CL004903 (NCI Metathesaurus Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
ConsentFormPatientResponsiblePersonSignedInd-2
Item
Has informed consent been signed and dated by patient and person conducting consent form discussion
boolean
C16468 (NCI Thesaurus ObjectClass)
C0009797 (UMLS 2011AA ObjectClass)
C16960 (NCI Thesaurus Property)
C0030705 (UMLS 2011AA Property)
C25657 (NCI Thesaurus Property-2)
C1273518 (UMLS 2011AA Property-2)
C25679 (NCI Thesaurus Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Item
Consent form language
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C16468 (NCI Thesaurus ObjectClass)
C0009797 (UMLS 2011AA ObjectClass)
C16779 (NCI Thesaurus Property)
C0023008 (UMLS 2011AA Property)
CL.56
Code List
Consent form language
CL Item
English Language (English)
C82847 (NCI Thesaurus)
C0376245 (UMLS 2011AA)
CL Item
French Language Other (French or Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
C16779 (NCI Thesaurus-3)
C0023008 (UMLS 2011AA-4)
C43854 (NCI Thesaurus-5)
C1556084 (UMLS 2011AA-6)
InformedConsentFormVersionSignedDate
Item
Consent form version date
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16468 (NCI Thesaurus ObjectClass)
C0009797 (UMLS 2011AA ObjectClass)
C25679 (NCI Thesaurus Property)
C25714 (NCI Thesaurus Property-2)
C0333052 (UMLS 2011AA Property)
ConsentFormPatientVersionSignedDate
Item
Date signed by patient
date
C16468 (NCI Thesaurus ObjectClass)
C0009797 (UMLS 2011AA ObjectClass)
C16960 (NCI Thesaurus Property)
C0030705 (UMLS 2011AA Property)
C25679 (NCI Thesaurus Property-2)
C25714 (NCI Thesaurus Property-3)
C0333052 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
ConsentFormPatientResponsiblePersonSignedName
Item
Name of person conducting the consent form discussion
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus Property)
C0030705 (UMLS 2011AA Property)
C25657 (NCI Thesaurus Property-2)
C1273518 (UMLS 2011AA Property-2)
C16468 (NCI Thesaurus ObjectClass)
C0009797 (UMLS 2011AA ObjectClass)
C25679 (NCI Thesaurus Property-3)
Investigator Signature Date
Item
Date of signature
date
C25164 (NCI Thesaurus ValueDomain)
C2346576 (UMLS CUI-1)
C25678 (NCI Thesaurus Property)
C0011008 (UMLS CUI-2)
C25367 (NCI Thesaurus ValueDomain-2)
C17089 (NCI Thesaurus ObjectClass)
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