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ID

43198

Beschrijving

Z1041: Registration Worksheet NCT00513292 Combination Chemotherapy and Paclitaxel Plus Trastuzumab in Treating Women With Palpable Breast Cancer That Can Be Removed by Surgery Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=211E7BC7-C479-7160-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=211E7BC7-C479-7160-E044-0003BA3F9857

Trefwoorden

Versies (6)
  1. 26-08-12 26-08-12 -
  2. 11-08-14 11-08-14 - Martin Dugas
  3. 09-01-15 09-01-15 - Martin Dugas
  4. 27-06-15 27-06-15 -
  5. 25-07-15 25-07-15 - Martin Dugas
  6. 20-09-21 20-09-21 -
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20 september 2021

DOI

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Licentie

Creative Commons BY-NC 3.0 Legacy
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    Registration Worksheet Breast Cancer Z1041 NCT00513292

    Engels

    No Instruction available.

    1 Formulieren  
    1. StudyEvent: Z1041: Registration Worksheet
      1. No Instruction available.
    Header Module
    Beschrijving

    Header Module

    Visit
    Beschrijving

    AmericanCollegeofSurgeonsOncologyGroupVisitPeriodAmericanCollegeofSurgeonsOncologyGroupVisitPeriodType

    Datatype

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    NCI Thesaurus Property
    C25616
    NCI Thesaurus ObjectClass
    C19712
    NCI Thesaurus ObjectClass-2
    C25716
    UMLS CUI-1
    C3641100
    Patient ID (Pt. ID issued during registration or previously issued patient ID)
    Beschrijving

    Patient Study ID

    Datatype

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C2348585
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25462
    NCI Thesaurus Property-2
    C25364
    First
    Beschrijving

    Patient Initials First

    Datatype

    text

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

    PatientMiddleInitialsName

    Datatype

    text

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

    Patient Initials Last

    Datatype

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS CUI-1
    C2986440
    NCI Thesaurus ObjectClass
    C16960
    UMLS CUI-2
    C1517741
    NCI Thesaurus Property
    C25536
    NCI Thesaurus Property-2
    C25551
    Institution No.
    Beschrijving

    Institution Number

    Datatype

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C1301943
    NCI Thesaurus ObjectClass
    C21541
    UMLS CUI-2
    C0805701
    NCI Thesaurus Property
    C25364
    Institution Name
    Beschrijving

    Institution Name

    Datatype

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS CUI-1
    C1301943
    NCI Thesaurus ObjectClass
    C21541
    NCI Thesaurus ValueDomain-2
    C21541
    NCI Thesaurus Property
    C25364
    Registration Date
    Beschrijving

    PatientRegistrationDate

    Datatype

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus ValueDomain-2
    C25367
    NCI Thesaurus Property
    C25646
    UMLS 2011AA Property
    C1514821
    Has patient previously been registered to an ACOSOG study
    Beschrijving

    PriorTherapyPatientAmericanCollegeofSurgeonsOncologyGroupStudyInd-2

    Datatype

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus ObjectClass-2
    C16124
    UMLS 2011AA ObjectClass-2
    C1514463
    NCI Thesaurus Property
    C19712
    UMLS 2011AA Property
    C1515944
    NCI Metathesaurus Property
    CL238692
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    Coordinating Group Protocol Number
    Beschrijving

    Protocol ID Coordinating Group

    Datatype

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C3274381
    NCI Thesaurus ObjectClass
    C25320
    UMLS CUI-2
    C1711341
    NCI Thesaurus Property
    C25462
    NCI Thesaurus Property-2
    C25364
    Patient Information
    Beschrijving

    Patient Information

    Date of Birth
    Beschrijving

    Birth Date

    Datatype

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS CUI-1
    C0421451
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus ValueDomain-2
    C25367
    NCI Thesaurus Property
    C25155
    Gender
    Beschrijving

    Gender

    Datatype

    text

    Alias
    NCI Thesaurus ValueDomain
    C25372
    UMLS CUI-1
    C0079399
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C17357
    Race (Mark all that apply)
    Beschrijving

    Racial Group

    Datatype

    text

    Alias
    NCI Thesaurus ValueDomain
    C25372
    UMLS CUI-1
    C0034510
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C17049
    Ethnicity (Mark only one)
    Beschrijving

    Ethnic Group

    Datatype

    text

    Alias
    NCI Thesaurus ValueDomain
    C25372
    UMLS CUI-1
    C0015031
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C16564
    Method of payment (Mark all that apply)
    Beschrijving

    PatientPaymentType

    Datatype

    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
    Other, specify
    Beschrijving

    PatientPaymentSpecify

    Datatype

    text

    Alias
    NCI Thesaurus ValueDomain
    C25685
    UMLS 2011AA ValueDomain
    C1521902
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C25371
    UMLS 2011AA Property
    C0680264
    Body weight
    Beschrijving

    Body weight

    Datatype

    float

    Maateenheden
    • kg
    Alias
    NCI Thesaurus ValueDomain
    C25209
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25208
    UMLS CUI-1
    C0005910
    kg
    Height
    Beschrijving

    Height

    Datatype

    float

    Maateenheden
    • cm
    Alias
    NCI Thesaurus ValueDomain
    C25209
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25347
    UMLS CUI-1
    C0005890
    cm
    Patient Zip Code (USA)
    Beschrijving

    PatientAddressPostalCode

    Datatype

    text

    Alias
    NCI Thesaurus ValueDomain
    C25162
    UMLS 2011AA ValueDomain
    C0805701
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C25407
    UMLS 2011AA Property
    C1442065
    Postal code (Canada)
    Beschrijving

    CanadaAddressPostalCode

    Datatype

    text

    Alias
    NCI Thesaurus ValueDomain
    C25162
    UMLS 2011AA ValueDomain
    C0805701
    NCI Thesaurus ObjectClass
    C16380
    UMLS 2011AA ObjectClass
    C0006823
    NCI Thesaurus Property
    C25407
    UMLS 2011AA Property
    C1442065
    Other Country Postal Code (Other)
    Beschrijving

    PatientOtherCountryAddressPostalCode

    Datatype

    text

    Alias
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C17649
    UMLS 2011AA Property
    C0205394
    NCI Thesaurus Property-2
    C25464
    UMLS 2011AA Property-2
    C0454664
    NCI Thesaurus Property-3
    C25407
    UMLS 2011AA Property-3
    C1442065
    NCI Thesaurus ValueDomain
    C25162
    UMLS 2011AA ValueDomain
    C0805701
    Country of Residence
    Beschrijving

    Country of current residence

    Datatype

    text

    Alias
    NCI Thesaurus ObjectClass
    C16960
    UMLS CUI-1
    C3258975
    NCI Thesaurus ValueDomain
    C25464
    NCI Thesaurus Property
    C25407
    NCI Thesaurus ValueDomain-2
    C42614
    Date Informed Consent Signed
    Beschrijving

    InformedConsentFormSignedDate

    Datatype

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ValueDomain-2
    C25367
    NCI Thesaurus ObjectClass
    C16468
    UMLS 2011AA ObjectClass
    C0009797
    NCI Thesaurus Property
    C25679
    HIPAA Authorization form
    Beschrijving

    HealthInsurancePortabilityandAccountabilityActAuthorizationStatus

    Datatype

    text

    Alias
    NCI Thesaurus ObjectClass
    C62504
    UMLS 2011AA ObjectClass
    C0600593
    NCI Thesaurus ValueDomain
    C25688
    UMLS 2011AA ValueDomain
    C0449438
    NCI Thesaurus Property
    C41192
    UMLS 2011AA Property
    C1524004
    HIPAA Authorization Date (If signed as a separate form,)
    Beschrijving

    PatientSignedDischargeMedicalRecordDate

    Datatype

    date

    Alias
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C25679
    NCI Metathesaurus Property
    C0012621
    NCI Thesaurus Property-2
    C45258
    UMLS 2011AA Property
    C0025102
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    Consent
    Beschrijving

    Consent

    Consent for correlative studies and specimen banking signed
    Beschrijving

    PatientCorrelativeStudySpecimenConsentInd-3

    Datatype

    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 signed (If yes,)
    Beschrijving

    PatientCorrelativeStudySpecimenConsentDate

    Datatype

    date

    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
    Inclusion Criteria
    Beschrijving

    Inclusion Criteria

    Inclusion Criteria
    Beschrijving

    AmericanCollegeofSurgeonsOncologyGroupPersonInclusionClinicalTrialEligibilityCriteriaType

    Datatype

    text

    Alias
    NCI Thesaurus ObjectClass
    C25190
    UMLS 2011AA ObjectClass
    C0027361
    NCI Thesaurus ObjectClass-2
    C19712
    UMLS 2011AA ObjectClass-2
    C1515944
    NCI Thesaurus Property
    C16112
    UMLS 2011AA Property
    C1516637
    NCI Thesaurus Property-2
    C25532
    UMLS 2011AA Property-2
    C1512693
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    Exclusion Criteria
    Beschrijving

    Exclusion Criteria

    Exclusion Criteria
    Beschrijving

    AmericanCollegeofSurgeonsOncologyGroupPersonExclusionCriteriaClinicalTrialEligibilityCriteriaType

    Datatype

    text

    Alias
    NCI Thesaurus ObjectClass
    C25190
    NCI Thesaurus ObjectClass-2
    C19712
    NCI Thesaurus Property
    C16112
    NCI Thesaurus Property-2
    C25370
    NCI Thesaurus ValueDomain
    C25284
    UMLS CUI-1
    C0680251
    Eligibility Assessment
    Beschrijving

    Eligibility Assessment

    Patient meets all eligibility criteria
    Beschrijving

    ACOSOGPatientEligibilityInd-2

    Datatype

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus ObjectClass-2
    C19712
    UMLS 2011AA ObjectClass-2
    C1515944
    NCI Thesaurus Property
    C25171
    UMLS 2011AA Property
    C0013893
    In the opinion of the investigator, is the patient eligible?
    Beschrijving

    Eligibility for trial

    Datatype

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS CUI-1
    C1302261
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25171
    Assessment Date
    Beschrijving

    LesionAssessmentDate

    Datatype

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ObjectClass
    C3824
    UMLS 2011AA ObjectClass
    C0221198
    NCI Thesaurus Property
    C20989
    UMLS 2011AA Property
    C0031809
    NCI Thesaurus ValueDomain-2
    C25367
    Randomization (Please indicate "arm" assigned as a result of randomization:)
    Beschrijving

    AmericanCollegeofSurgeonsOncologyGroupTreatmentArmRandomizationAmericanCollegeofSurgeonsOncologyGroupTreatmentArmRandomizationType

    Datatype

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    NCI Thesaurus Property
    C25196
    NCI Thesaurus ObjectClass
    C19712
    NCI Thesaurus ObjectClass-2
    C15538
    UMLS CUI-1
    C1522541
    Baseline Performace Status (ECOG/modified Zubrod scale)
    Beschrijving

    BaselinePerformanceStatusEasternCooperativeOncologyGroupScale

    Datatype

    text

    Alias
    NCI Thesaurus ObjectClass
    C25213
    UMLS 2011AA ObjectClass
    C1442488
    NCI Metathesaurus ObjectClass
    CL092952
    NCI Thesaurus Property
    C25491
    UMLS 2011AA Property
    C1512162
    NCI Thesaurus Property-2
    C25365
    UMLS 2011AA Property-2
    C0678257
    NCI Thesaurus ValueDomain
    C25664
    UMLS 2011AA ValueDomain
    C0349674
    Method of Evaluation
    Beschrijving

    Method of Evaluation

    Method of Evaluation
    Beschrijving

    Evaluation method

    Datatype

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS CUI-1
    C2911685
    NCI Thesaurus ObjectClass
    C20989
    NCI Thesaurus Property
    C16847
    Not done
    Beschrijving

    AssessmentMethodText

    Datatype

    text

    Alias
    NCI Thesaurus ValueDomain
    C25704
    UMLS 2011AA ValueDomain
    C1527021
    NCI Thesaurus ObjectClass
    C20989
    UMLS 2011AA ObjectClass
    C0031809
    NCI Thesaurus Property
    C16847
    UMLS 2011AA Property
    C0449851
    Image date
    Beschrijving

    DiagnosticImagingProcedureDate

    Datatype

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ValueDomain-2
    C25367
    NCI Thesaurus ObjectClass
    C16502
    UMLS 2011AA ObjectClass
    C0011923
    NCI Thesaurus Property
    C25218
    UMLS 2011AA Property
    C1948041
    Left Ventricular Ejection Fraction from MUGA (LVEF)
    Beschrijving

    HeartLeftVentricularEjectionFractionRadionuclideVentriculogramScanAssessmentPercentageValue

    Datatype

    float

    Maateenheden
    • %
    Alias
    NCI Thesaurus ObjectClass
    C12727
    NCI Thesaurus Property
    C20989
    NCI Thesaurus Property-2
    C38073
    NCI Thesaurus Property-3
    C37946
    NCI Thesaurus ValueDomain
    C25613
    NCI Thesaurus ValueDomain-2
    C25712
    UMLS CUI-1
    C2700377
    UMLS CUI-2
    C0521317
    %
    MUGA LLN (for LVEF)
    Beschrijving

    HeartLeftVentricularEjectionFractionRadionuclideVentriculogramScanAssessmentPercentageLowerLimitofNormalValue

    Datatype

    float

    Maateenheden
    • %
    Alias
    NCI Thesaurus ObjectClass
    C12727
    NCI Thesaurus Property
    C20989
    NCI Thesaurus Property-2
    C38073
    NCI Thesaurus Property-3
    C37946
    NCI Thesaurus ValueDomain
    C25613
    NCI Thesaurus ValueDomain-2
    C25712
    NCI Thesaurus ValueDomain-3
    C25555
    UMLS CUI-1
    C0428772
    UMLS CUI-2
    C1518030
    %
    Left Ventricular Ejection Fraction from ECHO (LVEF)
    Beschrijving

    HeartLeftVentricularEjectionFractionEchocardiogramAssessmentPercentageValue

    Datatype

    float

    Maateenheden
    • %
    Alias
    NCI Thesaurus ObjectClass
    C12727
    NCI Thesaurus Property
    C20989
    NCI Thesaurus Property-2
    C37945
    NCI Thesaurus Property-3
    C37946
    NCI Thesaurus ValueDomain
    C25613
    NCI Thesaurus ValueDomain-2
    C25712
    UMLS CUI-1
    C2700377
    UMLS CUI-2
    C2243117
    %
    ECHO LLN (for LVEF)
    Beschrijving

    HeartLeftVentricularEjectionFractionEchocardiogramAssessmentPercentageLowerLimitofNormalValue

    Datatype

    float

    Maateenheden
    • %
    Alias
    NCI Thesaurus ObjectClass
    C12727
    NCI Thesaurus Property
    C20989
    NCI Thesaurus Property-2
    C37945
    NCI Thesaurus Property-3
    C37946
    NCI Thesaurus ValueDomain
    C25613
    NCI Thesaurus ValueDomain-2
    C25712
    NCI Thesaurus ValueDomain-3
    C25555
    UMLS CUI-1
    C0428772
    UMLS CUI-2
    C1518030
    %
    Pregnancy Test
    Beschrijving

    Pregnancy Test

    Alias
    UMLS CUI-1
    C0032976
    Pregnancy test done
    Beschrijving

    PregnancyTestPerformedInd-2

    Datatype

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    NCI Thesaurus Property
    C38000
    UMLS 2011AA Property
    C0884358
    NCI Thesaurus ObjectClass
    C25742
    UMLS 2011AA ObjectClass
    C0032961
    NCI Thesaurus ObjectClass-2
    C25294
    UMLS 2011AA ObjectClass-2
    C0022885
    Reason pregnancy test not performed
    Beschrijving

    PregnancyLaboratoryProcedureNotPerformedReason

    Datatype

    text

    Alias
    NCI Thesaurus ObjectClass
    C25742
    UMLS 2011AA ObjectClass
    C0032961
    NCI Thesaurus ObjectClass-2
    C25294
    UMLS 2011AA ObjectClass-2
    C0022885
    NCI Thesaurus Property
    C25594
    UMLS 2011AA Property
    C1518422
    NCI Thesaurus Property-2
    C38000
    UMLS 2011AA Property-2
    C0884358
    NCI Thesaurus ValueDomain
    C25638
    UMLS 2011AA ValueDomain
    C0392360
    Other, specify
    Beschrijving

    PregnancyLaboratoryProcedureNotPerformedSpecify

    Datatype

    text

    Alias
    NCI Thesaurus ObjectClass
    C25742
    UMLS 2011AA ObjectClass
    C0032961
    NCI Thesaurus ObjectClass-2
    C25294
    UMLS 2011AA ObjectClass-2
    C0022885
    NCI Thesaurus Property
    C25594
    UMLS 2011AA Property
    C1518422
    NCI Thesaurus Property-2
    C38000
    UMLS 2011AA Property-2
    C0884358
    NCI Thesaurus ValueDomain
    C25685
    UMLS 2011AA ValueDomain
    C1521902
    Type of pregnancy test
    Beschrijving

    PregnancyLaboratoryProcedurePerformedType

    Datatype

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    NCI Thesaurus Property
    C38000
    UMLS 2011AA Property
    C0884358
    NCI Thesaurus ObjectClass
    C25742
    UMLS 2011AA ObjectClass
    C0032961
    NCI Thesaurus ObjectClass-2
    C25294
    UMLS 2011AA ObjectClass-2
    C0022885
    Date of pregnancy test
    Beschrijving

    PatientMostRecentPregnancyTestDate

    Datatype

    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
    Result
    Beschrijving

    LaboratoryProcedurePregnancyResultInd

    Datatype

    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
    Primary Tumor Biopsy
    Beschrijving

    Primary Tumor Biopsy

    Method of biopsy
    Beschrijving

    BiopsyProcedure

    Datatype

    text

    Alias
    NCI Thesaurus ObjectClass
    C15189
    UMLS 2011AA ObjectClass
    C0005558
    NCI Thesaurus Property
    C15368
    NCI Thesaurus ValueDomain
    C25218
    UMLS 2011AA ValueDomain
    C1948041
    Receptor Status, ER (mark one)
    Beschrijving

    ERLevelTumorStatus

    Datatype

    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
    Marker Test Method (mark all that apply)
    Beschrijving

    TumorMarkerTestType

    Datatype

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    NCI Thesaurus Property
    C25294
    UMLS 2011AA Property
    C0022885
    NCI Thesaurus ObjectClass
    C17220
    UMLS 2011AA ObjectClass
    C0041365
    HER-2/neu status (mark one)
    Beschrijving

    HER2/neuStatusType

    Datatype

    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
    PgR Status (mark one)
    Beschrijving

    PgRStatusType

    Datatype

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    NCI Thesaurus ObjectClass
    C17075
    UMLS 2011AA ObjectClass
    C0034833
    NCI Metathesaurus Property
    C0678257
    Histologic Grade
    Beschrijving

    BreastTumorHistologicGrade

    Datatype

    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
    Histologic Type
    Beschrijving

    BreastTumorHistologicCategory

    Datatype

    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
    Other specify
    Beschrijving

    Histologic Type, other

    Datatype

    text

    Alias
    NCI Thesaurus ValueDomain
    C25685
    UMLS CUI-1
    C1299220
    NCI Thesaurus ObjectClass
    C3262
    NCI Thesaurus Property
    C25526
    NCI Thesaurus Property-2
    C25161
    Clinical Stage
    Beschrijving

    Clinical Stage

    Alias
    UMLS CUI-1
    C1300072
    Clinical T Stage
    Beschrijving

    BreastTumorClinicalTStage

    Datatype

    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
    Clinical N Stage
    Beschrijving

    BreastTumorClinicalNStage

    Datatype

    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
    Is there a breast lesion >= 2 cm
    Beschrijving

    BreastCarcinomaTwoCentimeterPresentBreastStatus

    Datatype

    text

    Alias
    NCI Thesaurus ObjectClass
    C4872
    UMLS 2011AA ObjectClass
    C0678222
    NCI Thesaurus Property
    C25626
    UMLS 2011AA Property
    C0150312
    NCI Thesaurus Property-2
    C49668
    UMLS 2011AA Property-2
    C0475210
    NCI Thesaurus Property-3
    C66833
    UMLS 2011AA Property-3
    C0205448
    NCI Thesaurus ValueDomain
    C25688
    UMLS 2011AA ValueDomain
    C0449438
    Laboratory Values
    Beschrijving

    Laboratory Values

    Alias
    UMLS CUI-1
    C0022885
    Date Specimen collected (if multiple draw dates, enter first and last)
    Beschrijving

    SpecimenCollectedDate

    Datatype

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ObjectClass
    C19157
    UMLS 2011AA ObjectClass
    C0370003
    NCI Thesaurus Property
    C25452
    NCI Thesaurus Property-2
    C25275
    UMLS 2011AA Property
    C2745955
    WBC
    Beschrijving

    Leukocytes (WBC)

    Datatype

    float

    Alias
    NCI Thesaurus ObjectClass
    C25294
    UMLS CUI-1
    C0023508
    NCI Thesaurus Property
    C12529
    NCI Thesaurus Property-2
    C20200
    NCI Thesaurus ValueDomain
    C38046
    NCI Thesaurus ValueDomain-2
    C25712
    ANC
    Beschrijving

    Neutrophil count

    Datatype

    float

    Alias
    NCI Thesaurus ObjectClass
    C25294
    UMLS CUI-1
    C0200633
    NCI Thesaurus Property
    C12533
    NCI Thesaurus Property-2
    C20200
    NCI Thesaurus ValueDomain
    C25304
    NCI Thesaurus ValueDomain-2
    C25712
    Hemoglobin
    Beschrijving

    Hemoglobin

    Datatype

    float

    Maateenheden
    • g/dL
    Alias
    NCI Thesaurus Property
    C16676
    UMLS CUI-1
    C0019046
    NCI Thesaurus Property-2
    C20200
    NCI Thesaurus ObjectClass
    C25294
    NCI Thesaurus ValueDomain
    C25712
    g/dL
    Platelet count
    Beschrijving

    Platelets

    Datatype

    float

    Alias
    NCI Thesaurus ObjectClass
    C25294
    UMLS CUI-1
    C0005821
    NCI Thesaurus Property
    C20200
    NCI Thesaurus Property-2
    C12520
    NCI Thesaurus ValueDomain
    C38046
    NCI Thesaurus ValueDomain-2
    C25712
    Total Bilirubin
    Beschrijving

    LaboratoryProcedureTotalBilirubinResultSpecifiedValue

    Datatype

    float

    Maateenheden
    • 1000/uL
    Alias
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    NCI Thesaurus Property-2
    C38037
    UMLS 2011AA Property-2
    C0201913
    NCI Thesaurus ValueDomain
    C25712
    UMLS 2011AA ValueDomain
    C1522609
    NCI Thesaurus ValueDomain-2
    C38024
    UMLS 2011AA ValueDomain-2
    C0205369
    1000/uL
    Total bilirubin (mg/dl), ULN
    Beschrijving

    Bilirubin, Total ULN

    Datatype

    float

    Maateenheden
    • mg/dL
    Alias
    NCI Thesaurus ObjectClass
    C25294
    UMLS CUI-1
    C0201913
    NCI Thesaurus Property
    C20200
    UMLS CUI-2
    C1519815
    NCI Thesaurus Property-2
    C38037
    NCI Thesaurus ValueDomain
    C25712
    NCI Thesaurus ValueDomain-2
    C38024
    NCI Thesaurus ValueDomain-3
    C25706
    mg/dL
    SGOT (AST)
    Beschrijving

    SGOT (AST)

    Datatype

    float

    Maateenheden
    • U/L
    Alias
    NCI Thesaurus Property
    C25202
    UMLS CUI-1
    C0201899
    NCI Thesaurus Property-2
    C20200
    NCI Thesaurus ObjectClass
    C25294
    NCI Thesaurus ValueDomain
    C25712
    U/L
    SGOT (AST) ULN
    Beschrijving

    LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseResultUnspecifiedUpperLimitofNormalValue

    Datatype

    float

    Alias
    NCI Thesaurus ObjectClass
    C25294
    NCI Thesaurus Property
    C25202
    NCI Thesaurus Property-2
    C20200
    NCI Thesaurus ValueDomain
    C25712
    NCI Thesaurus ValueDomain-2
    C25706
    UMLS CUI-1
    C0242192
    UMLS CUI-2
    C1519815
    Alkaline Phosphatase
    Beschrijving

    HepaticAlkalinePhosphataseLabValue

    Datatype

    float

    Alias
    NCI Thesaurus ObjectClass
    C13308
    UMLS 2011AA ObjectClass
    C0205054
    NCI Thesaurus Property
    C37984
    UMLS 2011AA Property
    C0022877
    NCI Thesaurus ValueDomain
    C25712
    UMLS 2011AA ValueDomain
    C1522609
    NCI Thesaurus Property-2
    C16276
    UMLS 2011AA Property-2
    C0002059
    Alkaline Phosphatase ULN
    Beschrijving

    Alkaline Phosphatase ULN

    Datatype

    float

    Alias
    NCI Thesaurus ObjectClass
    C25294
    UMLS CUI-1
    C0151420
    NCI Thesaurus Property
    C20200
    NCI Thesaurus Property-2
    C16276
    NCI Thesaurus ValueDomain
    C25712
    NCI Thesaurus ValueDomain-2
    C25706
    Serum creatinine
    Beschrijving

    Creatinine, Serum

    Datatype

    float

    Maateenheden
    • mg/dL
    Alias
    NCI Thesaurus Property
    C20200
    UMLS CUI-1
    C0201976
    NCI Thesaurus Property-2
    C399
    NCI Thesaurus ObjectClass
    C25294
    NCI Thesaurus ValueDomain
    C25712
    mg/dL
    Creatinine ULN
    Beschrijving

    Creatinine, serum ULN

    Datatype

    float

    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
    History
    Beschrijving

    History

    Hypertension
    Beschrijving

    HypertensionHistoryInd-3

    Datatype

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    NCI Thesaurus ObjectClass
    C3117
    UMLS 2011AA ObjectClass
    C0020538
    NCI Thesaurus Property
    C18772
    UMLS 2011AA Property
    C0262926
    Smoking
    Beschrijving

    Smoking history

    Datatype

    text

    Alias
    NCI Thesaurus ValueDomain
    C25180
    UMLS CUI-1
    C1519384
    NCI Thesaurus ObjectClass
    C17934
    NCI Thesaurus Property
    C18772
    Cardiac Disease History
    Beschrijving

    PatientHeartDiseasesandDisordersPersonalMedicalHistoryInd-2

    Datatype

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C12727
    UMLS 2011AA Property
    C0018787
    NCI Thesaurus Property-2
    C2991
    UMLS 2011AA Property-2
    C0012634
    NCI Thesaurus Property-3
    C18772
    UMLS 2011AA Property-3
    C0262926
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    Cardiovascular Disease
    Beschrijving

    CardiovascularSystemDiseasesandDisordersMedicationBaselineUseInd-2

    Datatype

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C2991
    UMLS 2011AA ObjectClass
    C0012634
    NCI Thesaurus ObjectClass-2
    C459
    UMLS 2011AA ObjectClass-2
    C0013227
    NCI Thesaurus ObjectClass-3
    C12686
    UMLS 2011AA ObjectClass-3
    C0007226
    NCI Thesaurus Property
    C25213
    UMLS 2011AA Property
    C1442488
    NCI Thesaurus Property-2
    C25340
    UMLS 2011AA Property-2
    C0457083
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    Diabetes
    Beschrijving

    DiabetesMellitusDiseasesandDisordersMedicationBaselineUseInd-2

    Datatype

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C2991
    UMLS 2011AA ObjectClass
    C0012634
    NCI Thesaurus ObjectClass-2
    C2985
    UMLS 2011AA ObjectClass-2
    C0011849
    NCI Thesaurus ObjectClass-3
    C459
    UMLS 2011AA ObjectClass-3
    C0013227
    NCI Thesaurus Property
    C25213
    UMLS 2011AA Property
    C1442488
    NCI Thesaurus Property-2
    C25340
    UMLS 2011AA Property-2
    C0457083
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    Hyperlipidemia
    Beschrijving

    HyperlipidemiaDiseasesandDisordersMedicationBaselineUseInd-2

    Datatype

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C2991
    UMLS 2011AA ObjectClass
    C0012634
    NCI Thesaurus ObjectClass-2
    C459
    UMLS 2011AA ObjectClass-2
    C0013227
    NCI Thesaurus ObjectClass-3
    C34707
    UMLS 2011AA ObjectClass-3
    C0020473
    NCI Thesaurus Property
    C25213
    UMLS 2011AA Property
    C1442488
    NCI Thesaurus Property-2
    C25340
    UMLS 2011AA Property-2
    C0457083
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    Has the patient had a prior history of breast cancer requiring radiation
    Beschrijving

    PatientPriorBreastCarcinomaRadiationTherapyPersonalMedicalHistoryInd-2

    Datatype

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C15313
    UMLS 2011AA Property
    C1522449
    NCI Thesaurus Property-2
    C25629
    UMLS 2011AA Property-2
    C0332152
    NCI Thesaurus Property-3
    C4872
    UMLS 2011AA Property-3
    C0678222
    NCI Thesaurus Property-4
    C18772
    UMLS 2011AA Property-4
    C0262926
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    Location of tumor (If yes,)
    Beschrijving

    PatientPriorBreastCarcinomaRadiationTherapyPersonalMedicalHistoryAnatomicSite

    Datatype

    text

    Alias
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C15313
    UMLS 2011AA Property
    C1522449
    NCI Thesaurus Property-2
    C25629
    UMLS 2011AA Property-2
    C0332152
    NCI Thesaurus Property-3
    C4872
    UMLS 2011AA Property-3
    C0678222
    NCI Thesaurus Property-4
    C18772
    UMLS 2011AA Property-4
    C0262926
    NCI Thesaurus ValueDomain
    C13717
    UMLS 2011AA ValueDomain
    C1515974
    Footer
    Beschrijving

    Footer

    Did the Investigator sign the CRF indicating review of all data and certifying data are accurate and complete to the best of their knowledge
    Beschrijving

    CaseReportFormInvestigatorReviewInd-2

    Datatype

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    NCI Thesaurus ObjectClass
    C40988
    UMLS 2011AA ObjectClass
    C1516308
    NCI Thesaurus Property
    C25936
    UMLS 2011AA Property
    C0035173
    NCI Thesaurus Property-2
    C42729
    UMLS 2011AA Property-2
    C1552617
    Date of Investigator Signature
    Beschrijving

    Investigator Signature Date

    Datatype

    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: Z1041: Registration Worksheet
      1. No Instruction available.
    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    Alias
    Item Group
    Header Module
    Item
    Visit
    text
    C25284 (NCI Thesaurus ValueDomain)
    C25616 (NCI Thesaurus Property)
    C19712 (NCI Thesaurus ObjectClass)
    C25716 (NCI Thesaurus ObjectClass-2)
    C3641100 (UMLS CUI-1)
    CL.1
    Code List
    Visit
    CL Item
    Baseline (Baseline)
    C25213 (NCI Thesaurus)
    C1442488 (UMLS 2011AA)
    Patient Study ID
    Item
    Patient ID (Pt. ID issued during registration or previously issued patient ID)
    text
    C25337 (NCI Thesaurus ValueDomain)
    C2348585 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C25462 (NCI Thesaurus Property)
    C25364 (NCI Thesaurus Property-2)
    Patient Initials First
    Item
    First
    text
    C25191 (NCI Thesaurus ValueDomain)
    C2986440 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C0205435 (UMLS CUI-2)
    C25536 (NCI Thesaurus Property)
    C25509 (NCI Thesaurus Property-2)
    PatientMiddleInitialsName
    Item
    Middle
    text
    C25191 (NCI Thesaurus ValueDomain)
    C1547383 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25536 (NCI Thesaurus Property)
    C1555582 (UMLS 2011AA Property)
    C25569 (NCI Thesaurus Property-2)
    C0444598 (UMLS 2011AA Property-2)
    Patient Initials Last
    Item
    Last
    text
    C25191 (NCI Thesaurus ValueDomain)
    C2986440 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C1517741 (UMLS CUI-2)
    C25536 (NCI Thesaurus Property)
    C25551 (NCI Thesaurus Property-2)
    Institution Number
    Item
    Institution No.
    text
    C25337 (NCI Thesaurus ValueDomain)
    C1301943 (UMLS CUI-1)
    C21541 (NCI Thesaurus ObjectClass)
    C0805701 (UMLS CUI-2)
    C25364 (NCI Thesaurus Property)
    Institution Name
    Item
    Institution Name
    text
    C25191 (NCI Thesaurus ValueDomain)
    C1301943 (UMLS CUI-1)
    C21541 (NCI Thesaurus ObjectClass)
    C21541 (NCI Thesaurus ValueDomain-2)
    C25364 (NCI Thesaurus Property)
    PatientRegistrationDate
    Item
    Registration Date
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25367 (NCI Thesaurus ValueDomain-2)
    C25646 (NCI Thesaurus Property)
    C1514821 (UMLS 2011AA Property)
    PriorTherapyPatientAmericanCollegeofSurgeonsOncologyGroupStudyInd-2
    Item
    Has patient previously been registered to an ACOSOG study
    boolean
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C16124 (NCI Thesaurus ObjectClass-2)
    C1514463 (UMLS 2011AA ObjectClass-2)
    C19712 (NCI Thesaurus Property)
    C1515944 (UMLS 2011AA Property)
    CL238692 (NCI Metathesaurus Property)
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    Protocol ID Coordinating Group
    Item
    Coordinating Group Protocol Number
    text
    C25337 (NCI Thesaurus ValueDomain)
    C3274381 (UMLS CUI-1)
    C25320 (NCI Thesaurus ObjectClass)
    C1711341 (UMLS CUI-2)
    C25462 (NCI Thesaurus Property)
    C25364 (NCI Thesaurus Property-2)
    Item Group
    Patient Information
    Birth Date
    Item
    Date of Birth
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0421451 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C25367 (NCI Thesaurus ValueDomain-2)
    C25155 (NCI Thesaurus Property)
    Item
    Gender
    text
    C25372 (NCI Thesaurus ValueDomain)
    C0079399 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C17357 (NCI Thesaurus Property)
    CL.3
    Code List
    Gender
    CL Item
    Male (Male)
    C46109 (NCI Thesaurus)
    C1706180 (UMLS 2011AA)
    CL Item
    Female (Female)
    C46110 (NCI Thesaurus)
    C0086287 (UMLS 2011AA)
    Item
    Race (Mark all that apply)
    text
    C25372 (NCI Thesaurus ValueDomain)
    C0034510 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C17049 (NCI Thesaurus Property)
    CL.4
    Code List
    Race (Mark all that apply)
    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
    Could Not Be Determined Or Unsure (Unknown)
    C17998 (NCI Thesaurus)
    C0439673 (UMLS 2011AA)
    Item
    Ethnicity (Mark only one)
    text
    C25372 (NCI Thesaurus ValueDomain)
    C0015031 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C16564 (NCI Thesaurus Property)
    CL.5
    Code List
    Ethnicity (Mark only one)
    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
    Could Not Be Determined Or Unsure (UNKNOWN)
    C17998 (NCI Thesaurus)
    C0439673 (UMLS 2011AA)
    Item
    Method of payment (Mark all that apply)
    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.6
    Code List
    Method of payment (Mark all that apply)
    CL Item
    Private Insurance (Private insurance)
    CL Item
    Medicare (Medicare)
    C16665 (NCI Thesaurus)
    C0018717 (UMLS 2011AA)
    CL Item
    Medicare And Private Insurance (Medicare and private insurance)
    CL Item
    Medicaid (Medicaid)
    C0025071 (NCI Metathesaurus)
    CL Item
    Medicaid And Medicare (Medicaid and medicare)
    CL Item
    Military Or Veterans Sponsored Nos (Military or veterans sponsored NOS)
    CL Item
    Military Sponsored (including Champus & Tricare) (Military sponsored)
    CL Item
    Veterans Sponsored (Veterans sponsored)
    CL Item
    Self Pay (no Insurance) (Self pay)
    CL Item
    No Means Of Payment (no Insurance) (No means of payment)
    CL Item
    Other (Other)
    C17649 (NCI Thesaurus)
    C0205394 (UMLS 2011AA)
    PatientPaymentSpecify
    Item
    Other, specify
    text
    C25685 (NCI Thesaurus ValueDomain)
    C1521902 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25371 (NCI Thesaurus Property)
    C0680264 (UMLS 2011AA Property)
    Weight
    Item
    Body weight
    float
    C25209 (NCI Thesaurus ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C25208 (NCI Thesaurus Property)
    C0005910 (UMLS CUI-1)
    Height
    Item
    Height
    float
    C25209 (NCI Thesaurus ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C25347 (NCI Thesaurus Property)
    C0005890 (UMLS CUI-1)
    PatientAddressPostalCode
    Item
    Patient Zip Code (USA)
    text
    C25162 (NCI Thesaurus ValueDomain)
    C0805701 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25407 (NCI Thesaurus Property)
    C1442065 (UMLS 2011AA Property)
    CanadaAddressPostalCode
    Item
    Postal code (Canada)
    text
    C25162 (NCI Thesaurus ValueDomain)
    C0805701 (UMLS 2011AA ValueDomain)
    C16380 (NCI Thesaurus ObjectClass)
    C0006823 (UMLS 2011AA ObjectClass)
    C25407 (NCI Thesaurus Property)
    C1442065 (UMLS 2011AA Property)
    PatientOtherCountryAddressPostalCode
    Item
    Other Country Postal Code (Other)
    text
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C17649 (NCI Thesaurus Property)
    C0205394 (UMLS 2011AA Property)
    C25464 (NCI Thesaurus Property-2)
    C0454664 (UMLS 2011AA Property-2)
    C25407 (NCI Thesaurus Property-3)
    C1442065 (UMLS 2011AA Property-3)
    C25162 (NCI Thesaurus ValueDomain)
    C0805701 (UMLS 2011AA ValueDomain)
    Country of current residence
    Item
    Country of Residence
    text
    C16960 (NCI Thesaurus ObjectClass)
    C3258975 (UMLS CUI-1)
    C25464 (NCI Thesaurus ValueDomain)
    C25407 (NCI Thesaurus Property)
    C42614 (NCI Thesaurus ValueDomain-2)
    InformedConsentFormSignedDate
    Item
    Date Informed Consent Signed
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C25367 (NCI Thesaurus ValueDomain-2)
    C16468 (NCI Thesaurus ObjectClass)
    C0009797 (UMLS 2011AA ObjectClass)
    C25679 (NCI Thesaurus Property)
    Item
    HIPAA Authorization form
    text
    C62504 (NCI Thesaurus ObjectClass)
    C0600593 (UMLS 2011AA ObjectClass)
    C25688 (NCI Thesaurus ValueDomain)
    C0449438 (UMLS 2011AA ValueDomain)
    C41192 (NCI Thesaurus Property)
    C1524004 (UMLS 2011AA Property)
    CL.7
    Code List
    HIPAA Authorization form
    CL Item
    Included In Study Informed Consent (Included in Study Informed Consent)
    PatientSignedDischargeMedicalRecordDate
    Item
    HIPAA Authorization Date (If signed as a separate form,)
    date
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25679 (NCI Thesaurus Property)
    C0012621 (NCI Metathesaurus Property)
    C45258 (NCI Thesaurus Property-2)
    C0025102 (UMLS 2011AA Property)
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    Item Group
    Consent
    PatientCorrelativeStudySpecimenConsentInd-3
    Item
    Consent for correlative studies and specimen banking signed
    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 signed (If yes,)
    date
    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)
    Item Group
    Inclusion Criteria
    Item
    Inclusion Criteria
    text
    C25190 (NCI Thesaurus ObjectClass)
    C0027361 (UMLS 2011AA ObjectClass)
    C19712 (NCI Thesaurus ObjectClass-2)
    C1515944 (UMLS 2011AA ObjectClass-2)
    C16112 (NCI Thesaurus Property)
    C1516637 (UMLS 2011AA Property)
    C25532 (NCI Thesaurus Property-2)
    C1512693 (UMLS 2011AA Property-2)
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    CL.9
    Code List
    Inclusion Criteria
    CL Item
    Alkaline Phosphatase Must Be <= 2.5 X Uln For The Lab (Alkaline phosphatase must be <= 2.5 x ULN for the lab)
    CL Item
    Anc Must Be <= 1200/mm^3 (ANC must be <= 1200/mm^3)
    CL Item
    Ast Must Be <= 1.5 X Uln For The Lab (AST must be <= 1.5 x ULN for the lab)
    CL Item
    Breast Cancer Must Be Determined To Be Her2-positive Prior To Study Entry (Breast cancer must be determined to be HER2-positive prior to study entry)
    CL Item
    Breast Tumor Must Be Palpable And Measure >= 2 Cm According To Recist Criterion (Breast tumor must be palpable and measure >= 2 cm according to RECIST criterion)
    CL Item
    Diagnosis Of Invasive Adenocarcinoma Of Breast Must Have Been Made By Core Needle Biopsy (Diagnosis of invasive adenocarcinoma of breast must have been made by core needle biopsy)
    CL Item
    If Patient Had Skeletal Pain Or Alkaline Phosphatase > Uln But <= 2.5 X Uln, Bone Scan Must Show No Metastatic Disease (If patient had skeletal pain or alkaline phosphatase > ULN but <= 2.5 x ULN, bone scan must show NO metastatic disease)
    CL Item
    Patient Must Be Female And 18 Years Of Age Or Older (Patient must be female and 18 years of age or older)
    CL Item
    Patient Must Have An Ecog/ Zubrod Performance Status Of <= 1 (Patient must have an ECOG/ Zubrod performance status of <= 1)
    CL Item
    Platelet Count Must Be >=100,000 /mm^3 (Platelet count must be >=100,000/mm^3)
    CL Item
    Serum Creatinine Must Be <= Uln For The Lab (Serum creatinine must be <= ULN for the lab)
    CL Item
    Total Bilirubin Must Be <= Uln For The Lab (Total bilirubin must be <= ULN for the lab)
    CL Item
    Within 3 Months Prior To Study Entry, Patient Must Have A Baseline Left Ventricular Ejection Fraction (lvef) Measured By Muga Scan >= 55 (Within 3 months prior to study entry, patient must have a baseline left ventricular ejection fraction (LVEF) measured by MUGA scan >= 55)
    Item Group
    Exclusion Criteria
    Item
    Exclusion Criteria
    text
    C25190 (NCI Thesaurus ObjectClass)
    C19712 (NCI Thesaurus ObjectClass-2)
    C16112 (NCI Thesaurus Property)
    C25370 (NCI Thesaurus Property-2)
    C25284 (NCI Thesaurus ValueDomain)
    C0680251 (UMLS CUI-1)
    CL.10
    Code List
    Exclusion Criteria
    CL Item
    Patient Had Prior Therapy With Anthracyclines Or Taxanes For Any Malignancy (Patient had prior therapy with anthracyclines or taxanes for any malignancy)
    CL Item
    Patient Has Cardiac Disease That Would Preclude The Use Of Epirubicin Or Trastuzumab (Patient has cardiac disease that would preclude the use of epirubicin or trastuzumab)
    CL Item
    Patient Has Definitive Clinical Or Radiological Evidence Of Metastatic Disease (Patient has definitive clinical or radiological evidence of metastatic disease)
    CL Item
    Patient Has Had Administration Of Any Investigational Agents Within 30 Days Prior To Study Entry (Patient has had administration of any investigational agents within 30 days prior to study entry)
    CL Item
    Patient Has Had Surgical Axillary Staging Procedure Prior To Study Entry (excluding Fna Of Axillary Nodes) (Patient has had surgical axillary staging procedure prior to study entry (excluding FNA of axillary nodes))
    CL Item
    Patient Has History Of Ipsilateral Dcis Treated With Radiation Therapy (Patient has history of ipsilateral DCIS treated with radiation therapy)
    CL Item
    Patient Has Ipsilateral Cn2b Or Cn3 Disease (Patient has ipsilateral cN2b or cN3 disease)
    CL Item
    Patient Has Non-malignant Systemic Disease That Would Preclude Treatment With Either Regimen (Patient has non-malignant systemic disease that would preclude treatment with either regimen)
    CL Item
    Patient Has Prior History Of Invasive Breast Cancer (Patient has prior history of invasive breast cancer)
    CL Item
    Patient Has Psychiatric Or Addictive Disorder Or Any Other Condition That, In The Investigator?s Opinion, Precludes Patient From Meeting Eligibility Requirements (Patient has psychiatric or addictive disorder or any other condition that, in the investigator?s opinion, precludes patient from meeting eligibility requirements)
    CL Item
    Patient Has Synchronous Invasive Breast Cancer (Patient has synchronous invasive breast cancer)
    CL Item
    Patient Has Tumor Clinically Staged As T4 (Patient has tumor clinically staged as T4)
    CL Item
    Patient Is Receiving Therapy With Any Hormonal Agent (excluding Medication Discontinued Before Study Entry) (Patient is receiving therapy with ANY hormonal agent (excluding medication discontinued before study entry))
    CL Item
    Patient Of Child-bearing Potential Does Not Have Negative Urine/ Serum Pregnancy Test Within 2 Weeks Of Registration Or Patient Is Breast Feeding (Patient of child-bearing potential does not have negative urine/ serum pregnancy test within 2 weeks of registration or patient is breast feeding)
    CL Item
    Patient Received Treatment For This Breast Cancer Prior To Study Entry (excluding Hormonal Therapy That Ended Before Study Entry) (Patient received treatment for this breast cancer prior to study entry (excluding hormonal therapy that ended before study entry))
    CL Item
    grade 2 as defined by CTCAE v3.0=Patient Has Sensory/ Motor Neuropathy >= Grade 2 As Defined By Ctcae V3.0 (Patient has sensory/ motor neuropathy >)
    Item Group
    Eligibility Assessment
    ACOSOGPatientEligibilityInd-2
    Item
    Patient meets all eligibility criteria
    boolean
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C19712 (NCI Thesaurus ObjectClass-2)
    C1515944 (UMLS 2011AA ObjectClass-2)
    C25171 (NCI Thesaurus Property)
    C0013893 (UMLS 2011AA Property)
    Eligibility for trial
    Item
    In the opinion of the investigator, is the patient eligible?
    boolean
    C38148 (NCI Thesaurus ValueDomain)
    C1302261 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C25171 (NCI Thesaurus Property)
    LesionAssessmentDate
    Item
    Assessment Date
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C3824 (NCI Thesaurus ObjectClass)
    C0221198 (UMLS 2011AA ObjectClass)
    C20989 (NCI Thesaurus Property)
    C0031809 (UMLS 2011AA Property)
    C25367 (NCI Thesaurus ValueDomain-2)
    Item
    Randomization (Please indicate "arm" assigned as a result of randomization:)
    text
    C25284 (NCI Thesaurus ValueDomain)
    C25196 (NCI Thesaurus Property)
    C19712 (NCI Thesaurus ObjectClass)
    C15538 (NCI Thesaurus ObjectClass-2)
    C1522541 (UMLS CUI-1)
    CL.13
    Code List
    Randomization (Please indicate "arm" assigned as a result of randomization:)
    CL Item
    Neoadjuvant Treatment With Fec-75 12w, Followed By Paclitaxel And Trastuzumab, 12w, Surgery And Trastuzumab (Neoadjuvant treatment with FEC-75 12W, followed by Paclitaxel and Trastuzumab, 12W, surgery and Trastuzumab)
    CL Item
    Neoadjuvant Treatment With Paclitaxel 12w And Trastuzamab 13w Followed By Fec-75 And Trastuzumab, 12w, Surgery And Trastuzumab (Neoadjuvant treatment with Paclitaxel 12W and Trastuzamab 13W followed by FEC-75 and Trastuzumab, 12W, surgery and Trastuzumab)
    Item
    Baseline Performace Status (ECOG/modified Zubrod scale)
    text
    C25213 (NCI Thesaurus ObjectClass)
    C1442488 (UMLS 2011AA ObjectClass)
    CL092952 (NCI Metathesaurus ObjectClass)
    C25491 (NCI Thesaurus Property)
    C1512162 (UMLS 2011AA Property)
    C25365 (NCI Thesaurus Property-2)
    C0678257 (UMLS 2011AA Property-2)
    C25664 (NCI Thesaurus ValueDomain)
    C0349674 (UMLS 2011AA ValueDomain)
    CL.14
    Code List
    Baseline Performace Status (ECOG/modified Zubrod scale)
    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)
    Item Group
    Method of Evaluation
    Item
    Method of Evaluation
    text
    C25284 (NCI Thesaurus ValueDomain)
    C2911685 (UMLS CUI-1)
    C20989 (NCI Thesaurus ObjectClass)
    C16847 (NCI Thesaurus Property)
    CL.15
    Code List
    Method of Evaluation
    CL Item
    Contralateral Mammogram (Contralateral mammogram)
    CL Item
    Ipsilateral Mammogram (Ipsilateral mammogram)
    CL Item
    Ipsilateral Axilla Ultrasound (Ipsilateral Axilla Ultrasound)
    CL Item
    Muga Scan (MUGA scan)
    AssessmentMethodText
    Item
    Not done
    text
    C25704 (NCI Thesaurus ValueDomain)
    C1527021 (UMLS 2011AA ValueDomain)
    C20989 (NCI Thesaurus ObjectClass)
    C0031809 (UMLS 2011AA ObjectClass)
    C16847 (NCI Thesaurus Property)
    C0449851 (UMLS 2011AA Property)
    DiagnosticImagingProcedureDate
    Item
    Image date
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C25367 (NCI Thesaurus ValueDomain-2)
    C16502 (NCI Thesaurus ObjectClass)
    C0011923 (UMLS 2011AA ObjectClass)
    C25218 (NCI Thesaurus Property)
    C1948041 (UMLS 2011AA Property)
    LVEF MUGA
    Item
    Left Ventricular Ejection Fraction from MUGA (LVEF)
    float
    C12727 (NCI Thesaurus ObjectClass)
    C20989 (NCI Thesaurus Property)
    C38073 (NCI Thesaurus Property-2)
    C37946 (NCI Thesaurus Property-3)
    C25613 (NCI Thesaurus ValueDomain)
    C25712 (NCI Thesaurus ValueDomain-2)
    C2700377 (UMLS CUI-1)
    C0521317 (UMLS CUI-2)
    LVEF LLN
    Item
    MUGA LLN (for LVEF)
    float
    C12727 (NCI Thesaurus ObjectClass)
    C20989 (NCI Thesaurus Property)
    C38073 (NCI Thesaurus Property-2)
    C37946 (NCI Thesaurus Property-3)
    C25613 (NCI Thesaurus ValueDomain)
    C25712 (NCI Thesaurus ValueDomain-2)
    C25555 (NCI Thesaurus ValueDomain-3)
    C0428772 (UMLS CUI-1)
    C1518030 (UMLS CUI-2)
    LVEF ECHO
    Item
    Left Ventricular Ejection Fraction from ECHO (LVEF)
    float
    C12727 (NCI Thesaurus ObjectClass)
    C20989 (NCI Thesaurus Property)
    C37945 (NCI Thesaurus Property-2)
    C37946 (NCI Thesaurus Property-3)
    C25613 (NCI Thesaurus ValueDomain)
    C25712 (NCI Thesaurus ValueDomain-2)
    C2700377 (UMLS CUI-1)
    C2243117 (UMLS CUI-2)
    LVEF LLN
    Item
    ECHO LLN (for LVEF)
    float
    C12727 (NCI Thesaurus ObjectClass)
    C20989 (NCI Thesaurus Property)
    C37945 (NCI Thesaurus Property-2)
    C37946 (NCI Thesaurus Property-3)
    C25613 (NCI Thesaurus ValueDomain)
    C25712 (NCI Thesaurus ValueDomain-2)
    C25555 (NCI Thesaurus ValueDomain-3)
    C0428772 (UMLS CUI-1)
    C1518030 (UMLS CUI-2)
    Item Group
    Pregnancy Test
    C0032976 (UMLS CUI-1)
    PregnancyTestPerformedInd-2
    Item
    Pregnancy test done
    boolean
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    C38000 (NCI Thesaurus Property)
    C0884358 (UMLS 2011AA Property)
    C25742 (NCI Thesaurus ObjectClass)
    C0032961 (UMLS 2011AA ObjectClass)
    C25294 (NCI Thesaurus ObjectClass-2)
    C0022885 (UMLS 2011AA ObjectClass-2)
    Item
    Reason pregnancy test not performed
    text
    C25742 (NCI Thesaurus ObjectClass)
    C0032961 (UMLS 2011AA ObjectClass)
    C25294 (NCI Thesaurus ObjectClass-2)
    C0022885 (UMLS 2011AA ObjectClass-2)
    C25594 (NCI Thesaurus Property)
    C1518422 (UMLS 2011AA Property)
    C38000 (NCI Thesaurus Property-2)
    C0884358 (UMLS 2011AA Property-2)
    C25638 (NCI Thesaurus ValueDomain)
    C0392360 (UMLS 2011AA ValueDomain)
    CL.17
    Code List
    Reason pregnancy test not performed
    CL Item
    Postmenopausal (Post-menopausal)
    C15421 (NCI Thesaurus)
    C0232970 (UMLS 2011AA)
    CL Item
    Other (Other)
    C17649 (NCI Thesaurus)
    C0205394 (UMLS 2011AA)
    PregnancyLaboratoryProcedureNotPerformedSpecify
    Item
    Other, specify
    text
    C25742 (NCI Thesaurus ObjectClass)
    C0032961 (UMLS 2011AA ObjectClass)
    C25294 (NCI Thesaurus ObjectClass-2)
    C0022885 (UMLS 2011AA ObjectClass-2)
    C25594 (NCI Thesaurus Property)
    C1518422 (UMLS 2011AA Property)
    C38000 (NCI Thesaurus Property-2)
    C0884358 (UMLS 2011AA Property-2)
    C25685 (NCI Thesaurus ValueDomain)
    C1521902 (UMLS 2011AA ValueDomain)
    Item
    Type of pregnancy test
    text
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    C38000 (NCI Thesaurus Property)
    C0884358 (UMLS 2011AA Property)
    C25742 (NCI Thesaurus ObjectClass)
    C0032961 (UMLS 2011AA ObjectClass)
    C25294 (NCI Thesaurus ObjectClass-2)
    C0022885 (UMLS 2011AA ObjectClass-2)
    CL.18
    Code List
    Type of pregnancy test
    CL Item
    Serum (Serum)
    C13325 (NCI Thesaurus)
    C0229671 (UMLS 2011AA)
    CL Item
    Urine (Urine)
    C13283 (NCI Thesaurus)
    C0042036 (UMLS 2011AA)
    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
    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.19
    Code List
    Result
    CL Item
    Positive (positive)
    C25246 (NCI Thesaurus)
    C1446409 (UMLS 2011AA)
    CL Item
    Negative (negative)
    C25247 (NCI Thesaurus)
    C0205160 (UMLS 2011AA)
    Item Group
    Primary Tumor Biopsy
    Item
    Method of biopsy
    text
    C15189 (NCI Thesaurus ObjectClass)
    C0005558 (UMLS 2011AA ObjectClass)
    C15368 (NCI Thesaurus Property)
    C25218 (NCI Thesaurus ValueDomain)
    C1948041 (UMLS 2011AA ValueDomain)
    CL.20
    Code List
    Method of biopsy
    CL Item
    Fna (FNA)
    CL Item
    Core Needle Biopsy (Core needle biopsy)
    Item
    Receptor Status, ER (mark one)
    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.21
    Code List
    Receptor Status, ER (mark one)
    CL Item
    Positive (Positive)
    C25246 (NCI Thesaurus)
    C1446409 (UMLS 2011AA)
    CL Item
    Negative (Negative)
    C25247 (NCI Thesaurus)
    C0205160 (UMLS 2011AA)
    Item
    Marker Test Method (mark all that apply)
    text
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    C25294 (NCI Thesaurus Property)
    C0022885 (UMLS 2011AA Property)
    C17220 (NCI Thesaurus ObjectClass)
    C0041365 (UMLS 2011AA ObjectClass)
    CL.22
    Code List
    Marker Test Method (mark all that apply)
    CL Item
    Fluorescence In Situ Hybridization (fish) (Fluorescence in situ hybridization (FISH))
    CL Item
    Immunohistochemistry (ihc) (Immunohistochemistry (IHC))
    Item
    HER-2/neu status (mark one)
    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.23
    Code List
    HER-2/neu status (mark one)
    CL Item
    Positive (Positive)
    C25246 (NCI Thesaurus)
    C1446409 (UMLS 2011AA)
    CL Item
    Negative (Negative)
    C25247 (NCI Thesaurus)
    C0205160 (UMLS 2011AA)
    Item
    PgR Status (mark one)
    text
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    C17075 (NCI Thesaurus ObjectClass)
    C0034833 (UMLS 2011AA ObjectClass)
    C0678257 (NCI Metathesaurus Property)
    CL.24
    Code List
    PgR Status (mark one)
    CL Item
    Positive (Positive)
    C25246 (NCI Thesaurus)
    C1446409 (UMLS 2011AA)
    CL Item
    Negative (Negative)
    C25247 (NCI Thesaurus)
    C0205160 (UMLS 2011AA)
    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.25
    Code List
    Histologic Grade
    CL Item
    Well Differentiated (Grade I (low))
    CL Item
    Moderately Differentiated (Grade II (intermediate))
    CL Item
    Poorly Differentiated (Grade III (high))
    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.26
    Code List
    Histologic Type
    CL Item
    Ductal (Ductal)
    C25732 (NCI Thesaurus)
    C1512083 (UMLS 2011AA)
    CL Item
    Lobular (Lobular (pure > or =90%))
    C25557 (NCI Thesaurus)
    C0205417 (UMLS 2011AA)
    C25557 (NCI Thesaurus-3)
    C0205417 (UMLS 2011AA-4)
    CL Item
    Other Specify (Other)
    Histologic Type, other
    Item
    Other specify
    text
    C25685 (NCI Thesaurus ValueDomain)
    C1299220 (UMLS CUI-1)
    C3262 (NCI Thesaurus ObjectClass)
    C25526 (NCI Thesaurus Property)
    C25161 (NCI Thesaurus Property-2)
    Item Group
    Clinical Stage
    C1300072 (UMLS CUI-1)
    Item
    Clinical T Stage
    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.27
    Code List
    Clinical 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 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 Extension To (a) Chest Wall Or (b) Skin, Only As Described Below (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)
    Item
    Clinical N Stage
    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.28
    Code List
    Clinical N Stage
    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 To One Another Or To Other Structures (N2)
    CL Item
    Metastasis To Ipsilateral Mammary Lymph Node(s) (N3)
    Item
    Is there a breast lesion >= 2 cm
    text
    C4872 (NCI Thesaurus ObjectClass)
    C0678222 (UMLS 2011AA ObjectClass)
    C25626 (NCI Thesaurus Property)
    C0150312 (UMLS 2011AA Property)
    C49668 (NCI Thesaurus Property-2)
    C0475210 (UMLS 2011AA Property-2)
    C66833 (NCI Thesaurus Property-3)
    C0205448 (UMLS 2011AA Property-3)
    C25688 (NCI Thesaurus ValueDomain)
    C0449438 (UMLS 2011AA ValueDomain)
    CL.29
    Code List
    Is there a breast lesion >= 2 cm
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    No And Largest Nodal Metastasis < 2 Cm (No and largest nodal metastasis < 2 cm)
    CL Item
    No And Largest Nodal Metastasis >= 2 Cm (No and largest nodal metastasis >= 2 cm)
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    Item Group
    Laboratory Values
    C0022885 (UMLS CUI-1)
    SpecimenCollectedDate
    Item
    Date Specimen collected (if multiple draw dates, enter first and last)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C19157 (NCI Thesaurus ObjectClass)
    C0370003 (UMLS 2011AA ObjectClass)
    C25452 (NCI Thesaurus Property)
    C25275 (NCI Thesaurus Property-2)
    C2745955 (UMLS 2011AA Property)
    Leukocytes (WBC)
    Item
    WBC
    float
    C25294 (NCI Thesaurus ObjectClass)
    C0023508 (UMLS CUI-1)
    C12529 (NCI Thesaurus Property)
    C20200 (NCI Thesaurus Property-2)
    C38046 (NCI Thesaurus ValueDomain)
    C25712 (NCI Thesaurus ValueDomain-2)
    Neutrophil count
    Item
    ANC
    float
    C25294 (NCI Thesaurus ObjectClass)
    C0200633 (UMLS CUI-1)
    C12533 (NCI Thesaurus Property)
    C20200 (NCI Thesaurus Property-2)
    C25304 (NCI Thesaurus ValueDomain)
    C25712 (NCI Thesaurus ValueDomain-2)
    Hemoglobin
    Item
    Hemoglobin
    float
    C16676 (NCI Thesaurus Property)
    C0019046 (UMLS CUI-1)
    C20200 (NCI Thesaurus Property-2)
    C25294 (NCI Thesaurus ObjectClass)
    C25712 (NCI Thesaurus ValueDomain)
    Platelets
    Item
    Platelet count
    float
    C25294 (NCI Thesaurus ObjectClass)
    C0005821 (UMLS CUI-1)
    C20200 (NCI Thesaurus Property)
    C12520 (NCI Thesaurus Property-2)
    C38046 (NCI Thesaurus ValueDomain)
    C25712 (NCI Thesaurus ValueDomain-2)
    LaboratoryProcedureTotalBilirubinResultSpecifiedValue
    Item
    Total Bilirubin
    float
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    C38037 (NCI Thesaurus Property-2)
    C0201913 (UMLS 2011AA Property-2)
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    C38024 (NCI Thesaurus ValueDomain-2)
    C0205369 (UMLS 2011AA ValueDomain-2)
    Bilirubin, Total ULN
    Item
    Total bilirubin (mg/dl), ULN
    float
    C25294 (NCI Thesaurus ObjectClass)
    C0201913 (UMLS CUI-1)
    C20200 (NCI Thesaurus Property)
    C1519815 (UMLS CUI-2)
    C38037 (NCI Thesaurus Property-2)
    C25712 (NCI Thesaurus ValueDomain)
    C38024 (NCI Thesaurus ValueDomain-2)
    C25706 (NCI Thesaurus ValueDomain-3)
    SGOT (AST)
    Item
    SGOT (AST)
    float
    C25202 (NCI Thesaurus Property)
    C0201899 (UMLS CUI-1)
    C20200 (NCI Thesaurus Property-2)
    C25294 (NCI Thesaurus ObjectClass)
    C25712 (NCI Thesaurus ValueDomain)
    SGOT ULN
    Item
    SGOT (AST) ULN
    float
    C25294 (NCI Thesaurus ObjectClass)
    C25202 (NCI Thesaurus Property)
    C20200 (NCI Thesaurus Property-2)
    C25712 (NCI Thesaurus ValueDomain)
    C25706 (NCI Thesaurus ValueDomain-2)
    C0242192 (UMLS CUI-1)
    C1519815 (UMLS CUI-2)
    HepaticAlkalinePhosphataseLabValue
    Item
    Alkaline Phosphatase
    float
    C13308 (NCI Thesaurus ObjectClass)
    C0205054 (UMLS 2011AA ObjectClass)
    C37984 (NCI Thesaurus Property)
    C0022877 (UMLS 2011AA Property)
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    C16276 (NCI Thesaurus Property-2)
    C0002059 (UMLS 2011AA Property-2)
    Alkaline Phosphatase ULN
    Item
    Alkaline Phosphatase ULN
    float
    C25294 (NCI Thesaurus ObjectClass)
    C0151420 (UMLS CUI-1)
    C20200 (NCI Thesaurus Property)
    C16276 (NCI Thesaurus Property-2)
    C25712 (NCI Thesaurus ValueDomain)
    C25706 (NCI Thesaurus ValueDomain-2)
    Creatinine, Serum
    Item
    Serum creatinine
    float
    C20200 (NCI Thesaurus Property)
    C0201976 (UMLS CUI-1)
    C399 (NCI Thesaurus Property-2)
    C25294 (NCI Thesaurus ObjectClass)
    C25712 (NCI Thesaurus ValueDomain)
    Creatinine, serum ULN
    Item
    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)
    Item Group
    History
    HypertensionHistoryInd-3
    Item
    Hypertension
    boolean
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    C3117 (NCI Thesaurus ObjectClass)
    C0020538 (UMLS 2011AA ObjectClass)
    C18772 (NCI Thesaurus Property)
    C0262926 (UMLS 2011AA Property)
    Item
    Smoking
    text
    C25180 (NCI Thesaurus ValueDomain)
    C1519384 (UMLS CUI-1)
    C17934 (NCI Thesaurus ObjectClass)
    C18772 (NCI Thesaurus Property)
    CL.31
    Code List
    Smoking
    CL Item
    Never Smoked (Never smoked)
    CL Item
    Smoked In The Past (Smoked in the past)
    CL Item
    Currently Smoking (Currently smoking)
    PatientHeartDiseasesandDisordersPersonalMedicalHistoryInd-2
    Item
    Cardiac Disease History
    boolean
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C12727 (NCI Thesaurus Property)
    C0018787 (UMLS 2011AA Property)
    C2991 (NCI Thesaurus Property-2)
    C0012634 (UMLS 2011AA Property-2)
    C18772 (NCI Thesaurus Property-3)
    C0262926 (UMLS 2011AA Property-3)
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    CardiovascularSystemDiseasesandDisordersMedicationBaselineUseInd-2
    Item
    Cardiovascular Disease
    boolean
    C2991 (NCI Thesaurus ObjectClass)
    C0012634 (UMLS 2011AA ObjectClass)
    C459 (NCI Thesaurus ObjectClass-2)
    C0013227 (UMLS 2011AA ObjectClass-2)
    C12686 (NCI Thesaurus ObjectClass-3)
    C0007226 (UMLS 2011AA ObjectClass-3)
    C25213 (NCI Thesaurus Property)
    C1442488 (UMLS 2011AA Property)
    C25340 (NCI Thesaurus Property-2)
    C0457083 (UMLS 2011AA Property-2)
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    DiabetesMellitusDiseasesandDisordersMedicationBaselineUseInd-2
    Item
    Diabetes
    boolean
    C2991 (NCI Thesaurus ObjectClass)
    C0012634 (UMLS 2011AA ObjectClass)
    C2985 (NCI Thesaurus ObjectClass-2)
    C0011849 (UMLS 2011AA ObjectClass-2)
    C459 (NCI Thesaurus ObjectClass-3)
    C0013227 (UMLS 2011AA ObjectClass-3)
    C25213 (NCI Thesaurus Property)
    C1442488 (UMLS 2011AA Property)
    C25340 (NCI Thesaurus Property-2)
    C0457083 (UMLS 2011AA Property-2)
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    HyperlipidemiaDiseasesandDisordersMedicationBaselineUseInd-2
    Item
    Hyperlipidemia
    boolean
    C2991 (NCI Thesaurus ObjectClass)
    C0012634 (UMLS 2011AA ObjectClass)
    C459 (NCI Thesaurus ObjectClass-2)
    C0013227 (UMLS 2011AA ObjectClass-2)
    C34707 (NCI Thesaurus ObjectClass-3)
    C0020473 (UMLS 2011AA ObjectClass-3)
    C25213 (NCI Thesaurus Property)
    C1442488 (UMLS 2011AA Property)
    C25340 (NCI Thesaurus Property-2)
    C0457083 (UMLS 2011AA Property-2)
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    PatientPriorBreastCarcinomaRadiationTherapyPersonalMedicalHistoryInd-2
    Item
    Has the patient had a prior history of breast cancer requiring radiation
    boolean
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C15313 (NCI Thesaurus Property)
    C1522449 (UMLS 2011AA Property)
    C25629 (NCI Thesaurus Property-2)
    C0332152 (UMLS 2011AA Property-2)
    C4872 (NCI Thesaurus Property-3)
    C0678222 (UMLS 2011AA Property-3)
    C18772 (NCI Thesaurus Property-4)
    C0262926 (UMLS 2011AA Property-4)
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    Item
    Location of tumor (If yes,)
    text
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C15313 (NCI Thesaurus Property)
    C1522449 (UMLS 2011AA Property)
    C25629 (NCI Thesaurus Property-2)
    C0332152 (UMLS 2011AA Property-2)
    C4872 (NCI Thesaurus Property-3)
    C0678222 (UMLS 2011AA Property-3)
    C18772 (NCI Thesaurus Property-4)
    C0262926 (UMLS 2011AA Property-4)
    C13717 (NCI Thesaurus ValueDomain)
    C1515974 (UMLS 2011AA ValueDomain)
    CL.37
    Code List
    Location of tumor (If yes,)
    CL Item
    Left Breast: C47855 (Left Breast)
    C47855 (NCI Thesaurus)
    C0222601 (UMLS 2011AA)
    CL Item
    Right Breast: C47856 (Right Breast)
    C47856 (NCI Thesaurus)
    C0222600 (UMLS 2011AA)
    Item Group
    Footer
    CaseReportFormInvestigatorReviewInd-2
    Item
    Did the Investigator sign the CRF indicating review of all data and certifying data are accurate and complete to the best of their knowledge
    boolean
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    C40988 (NCI Thesaurus ObjectClass)
    C1516308 (UMLS 2011AA ObjectClass)
    C25936 (NCI Thesaurus Property)
    C0035173 (UMLS 2011AA Property)
    C42729 (NCI Thesaurus Property-2)
    C1552617 (UMLS 2011AA Property-2)
    Investigator Signature Date
    Item
    Date of Investigator 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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