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1092

Descrizione

CALGB 40601 REGISTRATION WORKSHEET Paclitaxel and Trastuzumab With or Without Lapatinib in Treating Patients With Stage II or Stage III Breast Cancer That Can Be Removed by Surgery Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=39E131B2-F4E4-13F1-E044-0003BA3F9857

collegamento

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=39E131B2-F4E4-13F1-E044-0003BA3F9857

Keywords

versioni (4)
  1. 27/08/12 27/08/12 -
  2. 09/01/15 09/01/15 - Martin Dugas
  3. 09/01/15 09/01/15 - Martin Dugas
  4. 17/09/21 17/09/21 -
Caricato su

27 agosto 2012

DOI

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Licenza

Creative Commons BY-NC 3.0 Legacy
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    Breast Cancer NCT00770809 Registration - CALGB 40601 REGISTRATION WORKSHEET - 2680365v1.0

    Inglese

    Endocrine Therapy in Combination with Anti-VEGF Therapy: A Randomized, Double-Blind, Placebo-Controlled Phase III Trial of Endocrine Therapy Alone or Endocrine Therapy plus for Women with Hormone Receptor-Positive Advanced Breast Cancer

    1 moduli  
    Header Module
    Descrizione

    Header Module

    Lead Institution
    Descrizione

    LeadInstitutionName

    Tipo di dati

    text

    Alias
    NCI Thesaurus ObjectClass
    C21541
    UMLS 2011AA ObjectClass
    C0018704
    NCI Thesaurus ObjectClass
    C25552
    UMLS 2011AA ObjectClass
    C1522538
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    NCI Thesaurus ValueDomain
    C25191
    UMLS 2011AA ValueDomain
    C1547383
    NCI Thesaurus ValueDomain
    C21541
    UMLS 2011AA ValueDomain
    C0018704
    Institution/Affiliate
    Descrizione

    CombinedInstitutionName

    Tipo di dati

    text

    Alias
    NCI Thesaurus ObjectClass
    C25454
    UMLS 2011AA ObjectClass
    C0205195
    NCI Thesaurus ObjectClass
    C21541
    UMLS 2011AA ObjectClass
    C0018704
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    NCI Thesaurus ValueDomain
    C25191
    UMLS 2011AA ValueDomain
    C1547383
    NCI Thesaurus ValueDomain
    C21541
    UMLS 2011AA ValueDomain
    C0018704
    CALGB Patient ID (Assigned)
    Descrizione

    PatientCALGBIdentifierNumber

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS 2011AA ValueDomain
    C0237753
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    NCI Thesaurus Property
    C25442
    UMLS 2011AA Property
    C1516238
    Physician of Record
    Descrizione

    RegisteredInvestigatorName

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS 2011AA ValueDomain
    C1547383
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    NCI Thesaurus ObjectClass
    C17089
    UMLS 2011AA ObjectClass
    C0035173
    NCI Thesaurus ObjectClass
    C25644
    Principal Investigator No.
    Descrizione

    NationalCancerInstitutePrincipalInvestigatorIdentifierNumber

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS 2011AA ValueDomain
    C0237753
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    NCI Thesaurus ObjectClass
    C19202
    UMLS 2011AA ObjectClass
    C1513882
    NCI Thesaurus ObjectClass
    C19924
    UMLS 2011AA ObjectClass
    C1521895
    Participating Group Name
    Descrizione

    ParticipatingGroupName

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS 2011AA ValueDomain
    C1547383
    NCI Thesaurus ObjectClass
    C25608
    UMLS 2011AA ObjectClass
    C0679823
    NCI Thesaurus ObjectClass
    C17005
    UMLS 2011AA ObjectClass
    C1257890
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    Protocol Administration
    Descrizione

    Protocol Administration

    IRB Approval Date
    Descrizione

    ProtocolIRBApprovedDate

    Tipo di dati

    date

    Alias
    NCI Thesaurus ObjectClass
    C25320
    UMLS 2011AA ObjectClass
    C1507394
    NCI Thesaurus Property
    C16741
    UMLS 2011AA Property
    C0086911
    NCI Thesaurus Property
    C25425
    UMLS 2011AA Property
    C0205540
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ValueDomain
    C25367
    Date Informed Consent Signed
    Descrizione

    InformedConsentFormSignedDate

    Tipo di dati

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ValueDomain
    C25367
    NCI Thesaurus ObjectClass
    C16468
    UMLS 2011AA ObjectClass
    C0009797
    NCI Thesaurus Property
    C25679
    Projected Start Date of Treatment
    Descrizione

    TreatmentProjectedBeginDate

    Tipo di dati

    date

    Alias
    NCI Thesaurus ObjectClass
    C15368
    NCI Thesaurus ObjectClass
    C25631
    NCI Thesaurus Property
    C25431
    UMLS 2011AA Property
    C0439659
    NCI Thesaurus Property
    C25275
    UMLS 2011AA Property
    C2745955
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ValueDomain
    C25431
    UMLS 2011AA ValueDomain
    C0439659
    HIPAA Authorization Date
    Descrizione

    PatientSignedDischargeMedicalRecordDate

    Tipo di dati

    date

    Alias
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C25679
    NCI Metathesaurus Property
    C0012621
    NCI Thesaurus Property
    C45258
    UMLS 2011AA Property
    C0025102
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    Contact Person at Institution
    Descrizione

    InstitutionContactPersonName

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS 2011AA ValueDomain
    C1547383
    NCI Thesaurus ObjectClass
    C21541
    UMLS 2011AA ObjectClass
    C0018704
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    NCI Thesaurus ObjectClass
    C25461
    UMLS 2011AA ObjectClass
    C0337611
    Phone
    Descrizione

    ContactPersonTelephoneNumber

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS 2011AA ValueDomain
    C0237753
    NCI Thesaurus ObjectClass
    C25190
    UMLS 2011AA ObjectClass
    C0027361
    NCI Thesaurus Property
    C25395
    UMLS 2011AA Property
    C0039457
    NCI Thesaurus ObjectClass
    C25461
    UMLS 2011AA ObjectClass
    C0337611
    Fax
    Descrizione

    ContactPersonFaxNumber

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS 2011AA ValueDomain
    C0237753
    NCI Thesaurus ObjectClass
    C25190
    UMLS 2011AA ObjectClass
    C0027361
    NCI Thesaurus ObjectClass
    C25461
    UMLS 2011AA ObjectClass
    C0337611
    NCI Thesaurus Property
    C25210
    UMLS 2011AA Property
    C0085205
    Patient Demographics/pre-treatment Characteristics
    Descrizione

    Patient Demographics/pre-treatment Characteristics

    Patient Initials (Last, First Middle)
    Descrizione

    PatientInitialsName

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS 2011AA ValueDomain
    C1547383
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C25536
    UMLS 2011AA Property
    C1555582
    Date of Birth (MM DD YYYY)
    Descrizione

    PatientBirthDate

    Tipo di dati

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus ValueDomain
    C25367
    NCI Thesaurus Property
    C25155
    UMLS 2011AA Property
    C0005615
    Patient Social Security Number
    Descrizione

    PatientPersonSocialSecurityNumber

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS 2011AA ValueDomain
    C0237753
    NCI Thesaurus ObjectClass
    C25190
    UMLS 2011AA ObjectClass
    C0027361
    NCI Thesaurus Property
    C25686
    UMLS 2011AA Property
    C1301821
    Patient Hospital No.
    Descrizione

    PatientMedicalRecordNumber

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS 2011AA ValueDomain
    C0237753
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C25261
    UMLS 2011AA Property
    C0205476
    NCI Thesaurus Property
    C25198
    UMLS 2011AA Property
    C0034869
    Gender
    Descrizione

    PatientGenderCategory

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C25372
    UMLS 2011AA ValueDomain
    C0683312
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C17357
    UMLS 2011AA Property
    C0079399
    Race (Mark all that apply)
    Descrizione

    PatientRaceCategory

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C25372
    UMLS 2011AA ValueDomain
    C0683312
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C17049
    UMLS 2011AA Property
    C0034510
    Ethnicity (Mark one)
    Descrizione

    PatientEthnicGroupCategory

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C25372
    UMLS 2011AA ValueDomain
    C0683312
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C16564
    UMLS 2011AA Property
    C0015031
    Patient Demographics/pre-treatment Characteristics2
    Descrizione

    Patient Demographics/pre-treatment Characteristics2

    Performance Status (ECOG/Zubrod scale)
    Descrizione

    PerformanceStatusAssessmentEasternCooperativeOncologyGroupScale

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C25664
    UMLS 2011AA ValueDomain
    C0349674
    NCI Thesaurus Property
    C25367
    NCI Thesaurus ValueDomain
    C25491
    UMLS 2011AA ValueDomain
    C1512162
    NCI Thesaurus ObjectClass
    C20641
    UMLS 2011AA ObjectClass
    C1518965
    Height (cm)
    Descrizione

    PatientHeightMeasurement

    Tipo di dati

    double

    Unità di misura
    • cm
    Alias
    NCI Thesaurus ValueDomain
    C25209
    UMLS 2011AA ValueDomain
    C0242485
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C25347
    UMLS 2011AA Property
    C0489786
    cm
    Weight (kg)
    Descrizione

    PatientWeightMeasurement

    Tipo di dati

    double

    Unità di misura
    • Kg
    Alias
    NCI Thesaurus ValueDomain
    C25209
    UMLS 2011AA ValueDomain
    C0242485
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C25208
    UMLS 2011AA Property
    C0043100
    Kg
    Body Surface Area (m^2)
    Descrizione

    PatientBodySurfaceAreaMeasurement

    Tipo di dati

    double

    Alias
    NCI Thesaurus ValueDomain
    C25209
    UMLS 2011AA ValueDomain
    C0242485
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C25157
    UMLS 2011AA Property
    C0005902
    Method of Payment (USA only Mark one)
    Descrizione

    PatientPaymentType

    Tipo di dati

    text

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

    DiseaseDescriptionText

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C25704
    UMLS 2011AA ValueDomain
    C1527021
    NCI Thesaurus ObjectClass
    C2991
    UMLS 2011AA ObjectClass
    C0012634
    NCI Thesaurus Property
    C25365
    UMLS 2011AA Property
    C0678257
    Stage
    Descrizione

    BreastTumorStageGroupingStage

    Tipo di dati

    text

    Alias
    NCI Thesaurus ObjectClass
    C3262
    UMLS 2011AA ObjectClass
    C0027651
    NCI Thesaurus ObjectClass
    C12971
    UMLS 2011AA ObjectClass
    C0006141
    NCI Thesaurus ValueDomain
    C16899
    UMLS 2011AA ValueDomain
    C1300072
    NCI Thesaurus Property
    C38027
    UMLS 2011AA Property
    C1519504
    Pathologic type
    Descrizione

    DiseasesandDisordersPathologyDescriptionText

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C25704
    UMLS 2011AA ValueDomain
    C1527021
    NCI Thesaurus ObjectClass
    C2991
    UMLS 2011AA ObjectClass
    C0012634
    NCI Thesaurus Property
    C18189
    UMLS 2011AA Property
    C0030664
    NCI Thesaurus Property
    C25365
    UMLS 2011AA Property
    C0678257
    Patient Zip Code
    Descrizione

    PatientAddressPostalCode

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C25162
    UMLS 2011AA ValueDomain
    C0805701
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C25407
    UMLS 2011AA Property
    C1442065
    Country of Residence (if not USA)
    Descrizione

    PatientAddressCountryName

    Tipo di dati

    text

    Alias
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus ValueDomain
    C25464
    UMLS 2011AA ValueDomain
    C0454664
    NCI Thesaurus Property
    C25407
    UMLS 2011AA Property
    C1442065
    NCI Thesaurus ValueDomain
    C42614
    UMLS 2011AA ValueDomain
    C0027365
    Certification Of Eligibility And Protocol Design
    Descrizione

    Certification Of Eligibility And Protocol Design

    In the opinion of the investigator, is the patient eligible?
    Descrizione

    PatientEligibilityIndicator

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C25171
    UMLS 2011AA Property
    C0013893
    Protocol Design
    Descrizione

    Protocol Design

    Stratification factors
    Descrizione

    ClinicalStudyProtocolStratificationFactorsType

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    NCI Thesaurus ObjectClass
    C25320
    UMLS 2011AA ObjectClass
    C1507394
    NCI Thesaurus Property
    C16153
    UMLS 2011AA Property
    C1514984
    Assigned Treatment Arm
    Descrizione

    ProtocolTreatmentArmAssignmentType

    Tipo di dati

    text

    Alias
    NCI Thesaurus ObjectClass
    C15368
    NCI Thesaurus ObjectClass
    C42651
    UMLS 2011AA ObjectClass
    C0442711
    NCI Thesaurus Property
    C32141
    UMLS 2011AA Property
    C1140618
    NCI Thesaurus Property
    C25426
    UMLS 2011AA Property
    C1516050
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    Initial Patient Consent For Specimen Use
    Descrizione

    Initial Patient Consent For Specimen Use

    Patient's Initial Consent given for specimen use for research on the patient's cancer?
    Descrizione

    SpecimenResearchConsentRelatedInd-3

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    NCI Thesaurus Property
    C15319
    NCI Thesaurus ObjectClass
    C19157
    UMLS 2011AA ObjectClass
    C0370003
    NCI Thesaurus Property
    C25460
    UMLS 2011AA Property
    C1511481
    Patient's initial consent given for specimen use for genetic research relating to the study treatment
    Descrizione

    SpecimenRelatedGeneticResearchConsentInd-2

    Tipo di dati

    text

    Alias
    NCI Thesaurus ObjectClass
    C19157
    UMLS 2011AA ObjectClass
    C0370003
    NCI Thesaurus Property
    C15319
    NCI Thesaurus Property
    C25648
    UMLS 2011AA Property
    C0439849
    NCI Thesaurus Property
    C17938
    UMLS 2011AA Property
    C0314603
    NCI Thesaurus Property
    C25460
    UMLS 2011AA Property
    C1511481
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    Patient's Initial Consent given for specimen kept for future use in research to learn about, prevent, or treat cancer
    Descrizione

    PersonSpecimenMalignantNeoplasmResearchConsentInd-2

    Tipo di dati

    text

    Alias
    NCI Thesaurus ObjectClass
    C25190
    UMLS 2011AA ObjectClass
    C0027361
    NCI Thesaurus Property
    C15319
    NCI Thesaurus Property
    C9305
    UMLS 2011AA Property
    C0006826
    NCI Thesaurus Property
    C19157
    UMLS 2011AA Property
    C0370003
    NCI Thesaurus Property
    C25460
    UMLS 2011AA Property
    C1511481
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    Patient's initial consent given for specimen(s) may be kept for use in research to learn about, prevent, or treat other health problems (for example: diabetes, Alzheimer's disease, or heart disease)
    Descrizione

    PatientOtherDiseaseorDisorderClinicalStudyConsentInd-2

    Tipo di dati

    text

    Alias
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C17649
    UMLS 2011AA Property
    C0205394
    NCI Thesaurus Property
    C2991
    UMLS 2011AA Property
    C0012634
    NCI Thesaurus Property
    C15206
    UMLS 2011AA Property
    C0008972
    NCI Thesaurus Property
    C25460
    UMLS 2011AA Property
    C1511481
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    Patient's initial consent given for further contact regarding specimen?
    Descrizione

    PatientContactConsentInd-3

    Tipo di dati

    text

    Alias
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C67527
    UMLS 2011AA Property
    C0016884
    NCI Thesaurus Property
    C25460
    UMLS 2011AA Property
    C1511481
    NCI Thesaurus Property
    C16452
    UMLS 2011AA Property
    C0009452
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    Tissue Procurement Kit
    Descrizione

    Tissue Procurement Kit

    Name
    Descrizione

    SpecimenSubmissionContactPersonIdentifierName

    Tipo di dati

    text

    Alias
    NCI Thesaurus ObjectClass
    C19157
    UMLS 2011AA ObjectClass
    C0370003
    NCI Thesaurus ObjectClass
    C25461
    UMLS 2011AA ObjectClass
    C0337611
    NCI Thesaurus ObjectClass
    C25694
    UMLS 2011AA ObjectClass
    C1515022
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    NCI Thesaurus ValueDomain
    C25191
    UMLS 2011AA ValueDomain
    C1547383
    Institution
    Descrizione

    SpecimenSubmissionInstitutionName

    Tipo di dati

    text

    Alias
    NCI Thesaurus ObjectClass
    C21541
    UMLS 2011AA ObjectClass
    C0018704
    NCI Thesaurus ObjectClass
    C19157
    UMLS 2011AA ObjectClass
    C0370003
    NCI Thesaurus ObjectClass
    C25694
    UMLS 2011AA ObjectClass
    C1515022
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    NCI Thesaurus ValueDomain
    C25191
    UMLS 2011AA ValueDomain
    C1547383
    Shipping Address
    Descrizione

    SpecimenSubmissionInstitutionAddressText

    Tipo di dati

    text

    Alias
    NCI Thesaurus ObjectClass
    C21541
    UMLS 2011AA ObjectClass
    C0018704
    NCI Thesaurus ObjectClass
    C19157
    UMLS 2011AA ObjectClass
    C0370003
    NCI Thesaurus ObjectClass
    C25694
    UMLS 2011AA ObjectClass
    C1515022
    NCI Thesaurus Property
    C25407
    UMLS 2011AA Property
    C1442065
    NCI Thesaurus ValueDomain
    C25704
    UMLS 2011AA ValueDomain
    C1527021
    Phone
    Descrizione

    SpecimenSubmissionContactPersonTelephoneNumber

    Tipo di dati

    text

    Alias
    NCI Thesaurus ObjectClass
    C19157
    UMLS 2011AA ObjectClass
    C0370003
    NCI Thesaurus ObjectClass
    C25461
    UMLS 2011AA ObjectClass
    C0337611
    NCI Thesaurus ObjectClass
    C25694
    UMLS 2011AA ObjectClass
    C1515022
    NCI Thesaurus Property
    C40978
    UMLS 2011AA Property
    C1515258
    NCI Thesaurus ValueDomain
    C25337
    UMLS 2011AA ValueDomain
    C0237753
    NCI Thesaurus ValueDomain
    C25395
    UMLS 2011AA ValueDomain
    C0039457
    FAX
    Descrizione

    SpecimenSubmissionContactPersonFaxNumber

    Tipo di dati

    text

    Alias
    NCI Thesaurus ObjectClass
    C19157
    UMLS 2011AA ObjectClass
    C0370003
    NCI Thesaurus ObjectClass
    C25461
    UMLS 2011AA ObjectClass
    C0337611
    NCI Thesaurus ObjectClass
    C25694
    UMLS 2011AA ObjectClass
    C1515022
    NCI Thesaurus Property
    C42879
    UMLS 2011AA Property
    C1549619
    NCI Thesaurus ValueDomain
    C25337
    UMLS 2011AA ValueDomain
    C0237753
    NCI Thesaurus ValueDomain
    C25395
    UMLS 2011AA ValueDomain
    C0039457
    Email
    Descrizione

    SpecimenSubmissionContactPersonE-mailAddressText

    Tipo di dati

    text

    Alias
    NCI Thesaurus ObjectClass
    C19157
    UMLS 2011AA ObjectClass
    C0370003
    NCI Thesaurus ObjectClass
    C25461
    UMLS 2011AA ObjectClass
    C0337611
    NCI Thesaurus ObjectClass
    C25694
    UMLS 2011AA ObjectClass
    C1515022
    NCI Thesaurus Property
    C42775
    UMLS 2011AA Property
    C1705961
    NCI Thesaurus ValueDomain
    C25704
    UMLS 2011AA ValueDomain
    C1527021
    Registration Information
    Descrizione

    Registration Information

    Registration Date
    Descrizione

    PatientRegistrationDate

    Tipo di dati

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus ValueDomain
    C25367
    NCI Thesaurus Property
    C25646
    UMLS 2011AA Property
    C1514821
    CALGB Patient ID (Assigned)
    Descrizione

    PatientCALGBIdentifierNumber

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS 2011AA ValueDomain
    C0237753
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    NCI Thesaurus Property
    C25442
    UMLS 2011AA Property
    C1516238
    Participating Group Patient ID (Assigned)
    Descrizione

    PatientParticipatingIdentifierNumber

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS 2011AA ValueDomain
    C0237753
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C25608
    UMLS 2011AA Property
    C0679823
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    Registrar's Signature
    Descrizione

    RegisteringPersonIdentifierSignatureName

    Tipo di dati

    text

    Alias
    NCI Thesaurus ObjectClass
    C25190
    UMLS 2011AA ObjectClass
    C0027361
    NCI Thesaurus ObjectClass
    C25645
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    NCI Thesaurus ValueDomain
    C25191
    UMLS 2011AA ValueDomain
    C1547383
    NCI Thesaurus ValueDomain
    C25678
    UMLS 2011AA ValueDomain
    C1519316
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    1 moduli
    Name
    genere
    Description | Question | Decode (Coded Value)
    Tipo di dati
    Alias
    Item Group
    Header Module
    LeadInstitutionName
    Item
    Lead Institution
    text
    C21541 (NCI Thesaurus ObjectClass)
    C0018704 (UMLS 2011AA ObjectClass)
    C25552 (NCI Thesaurus ObjectClass)
    C1522538 (UMLS 2011AA ObjectClass)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    C25191 (NCI Thesaurus ValueDomain)
    C1547383 (UMLS 2011AA ValueDomain)
    C21541 (NCI Thesaurus ValueDomain)
    C0018704 (UMLS 2011AA ValueDomain)
    CombinedInstitutionName
    Item
    Institution/Affiliate
    text
    C25454 (NCI Thesaurus ObjectClass)
    C0205195 (UMLS 2011AA ObjectClass)
    C21541 (NCI Thesaurus ObjectClass)
    C0018704 (UMLS 2011AA ObjectClass)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    C25191 (NCI Thesaurus ValueDomain)
    C1547383 (UMLS 2011AA ValueDomain)
    C21541 (NCI Thesaurus ValueDomain)
    C0018704 (UMLS 2011AA ValueDomain)
    PatientCALGBIdentifierNumber
    Item
    CALGB Patient ID (Assigned)
    text
    C25337 (NCI Thesaurus ValueDomain)
    C0237753 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    C25442 (NCI Thesaurus Property)
    C1516238 (UMLS 2011AA Property)
    RegisteredInvestigatorName
    Item
    Physician of Record
    text
    C25191 (NCI Thesaurus ValueDomain)
    C1547383 (UMLS 2011AA ValueDomain)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    C17089 (NCI Thesaurus ObjectClass)
    C0035173 (UMLS 2011AA ObjectClass)
    C25644 (NCI Thesaurus ObjectClass)
    NationalCancerInstitutePrincipalInvestigatorIdentifierNumber
    Item
    Principal Investigator No.
    text
    C25337 (NCI Thesaurus ValueDomain)
    C0237753 (UMLS 2011AA ValueDomain)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    C19202 (NCI Thesaurus ObjectClass)
    C1513882 (UMLS 2011AA ObjectClass)
    C19924 (NCI Thesaurus ObjectClass)
    C1521895 (UMLS 2011AA ObjectClass)
    ParticipatingGroupName
    Item
    Participating Group Name
    text
    C25191 (NCI Thesaurus ValueDomain)
    C1547383 (UMLS 2011AA ValueDomain)
    C25608 (NCI Thesaurus ObjectClass)
    C0679823 (UMLS 2011AA ObjectClass)
    C17005 (NCI Thesaurus ObjectClass)
    C1257890 (UMLS 2011AA ObjectClass)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    Item Group
    Protocol Administration
    ProtocolIRBApprovedDate
    Item
    IRB Approval Date
    date
    C25320 (NCI Thesaurus ObjectClass)
    C1507394 (UMLS 2011AA ObjectClass)
    C16741 (NCI Thesaurus Property)
    C0086911 (UMLS 2011AA Property)
    C25425 (NCI Thesaurus Property)
    C0205540 (UMLS 2011AA Property)
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C25367 (NCI Thesaurus ValueDomain)
    InformedConsentFormSignedDate
    Item
    Date Informed Consent Signed
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C25367 (NCI Thesaurus ValueDomain)
    C16468 (NCI Thesaurus ObjectClass)
    C0009797 (UMLS 2011AA ObjectClass)
    C25679 (NCI Thesaurus Property)
    TreatmentProjectedBeginDate
    Item
    Projected Start Date of Treatment
    date
    C15368 (NCI Thesaurus ObjectClass)
    C25631 (NCI Thesaurus ObjectClass)
    C25431 (NCI Thesaurus Property)
    C0439659 (UMLS 2011AA Property)
    C25275 (NCI Thesaurus Property)
    C2745955 (UMLS 2011AA Property)
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C25431 (NCI Thesaurus ValueDomain)
    C0439659 (UMLS 2011AA ValueDomain)
    PatientSignedDischargeMedicalRecordDate
    Item
    HIPAA Authorization Date
    date
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25679 (NCI Thesaurus Property)
    C0012621 (NCI Metathesaurus Property)
    C45258 (NCI Thesaurus Property)
    C0025102 (UMLS 2011AA Property)
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    InstitutionContactPersonName
    Item
    Contact Person at Institution
    text
    C25191 (NCI Thesaurus ValueDomain)
    C1547383 (UMLS 2011AA ValueDomain)
    C21541 (NCI Thesaurus ObjectClass)
    C0018704 (UMLS 2011AA ObjectClass)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    C25461 (NCI Thesaurus ObjectClass)
    C0337611 (UMLS 2011AA ObjectClass)
    ContactPersonTelephoneNumber
    Item
    Phone
    text
    C25337 (NCI Thesaurus ValueDomain)
    C0237753 (UMLS 2011AA ValueDomain)
    C25190 (NCI Thesaurus ObjectClass)
    C0027361 (UMLS 2011AA ObjectClass)
    C25395 (NCI Thesaurus Property)
    C0039457 (UMLS 2011AA Property)
    C25461 (NCI Thesaurus ObjectClass)
    C0337611 (UMLS 2011AA ObjectClass)
    ContactPersonFaxNumber
    Item
    Fax
    text
    C25337 (NCI Thesaurus ValueDomain)
    C0237753 (UMLS 2011AA ValueDomain)
    C25190 (NCI Thesaurus ObjectClass)
    C0027361 (UMLS 2011AA ObjectClass)
    C25461 (NCI Thesaurus ObjectClass)
    C0337611 (UMLS 2011AA ObjectClass)
    C25210 (NCI Thesaurus Property)
    C0085205 (UMLS 2011AA Property)
    Item Group
    Patient Demographics/pre-treatment Characteristics
    PatientInitialsName
    Item
    Patient Initials (Last, First 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)
    PatientBirthDate
    Item
    Date of Birth (MM DD YYYY)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25367 (NCI Thesaurus ValueDomain)
    C25155 (NCI Thesaurus Property)
    C0005615 (UMLS 2011AA Property)
    PatientPersonSocialSecurityNumber
    Item
    Patient Social Security Number
    text
    C25337 (NCI Thesaurus ValueDomain)
    C0237753 (UMLS 2011AA ValueDomain)
    C25190 (NCI Thesaurus ObjectClass)
    C0027361 (UMLS 2011AA ObjectClass)
    C25686 (NCI Thesaurus Property)
    C1301821 (UMLS 2011AA Property)
    PatientMedicalRecordNumber
    Item
    Patient Hospital No.
    text
    C25337 (NCI Thesaurus ValueDomain)
    C0237753 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25261 (NCI Thesaurus Property)
    C0205476 (UMLS 2011AA Property)
    C25198 (NCI Thesaurus Property)
    C0034869 (UMLS 2011AA Property)
    Item
    Gender
    text
    C25372 (NCI Thesaurus ValueDomain)
    C0683312 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C17357 (NCI Thesaurus Property)
    C0079399 (UMLS 2011AA Property)
    CL.1
    Code List
    Gender
    CL Item
    Female (FEMALE)
    C46110 (NCI Thesaurus)
    C0015780 (UMLS 2011AA)
    CL Item
    Male (MALE)
    C46109 (NCI Thesaurus)
    C1706180 (UMLS 2011AA)
    Item
    Race (Mark all that apply)
    text
    C25372 (NCI Thesaurus ValueDomain)
    C0683312 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C17049 (NCI Thesaurus Property)
    C0034510 (UMLS 2011AA Property)
    CL.2
    Code List
    Race (Mark all that apply)
    CL Item
    A Person Having Origins In Any Of The Original Peoples Of North And South America (including Central America), And Who Maintains Tribal Affiliation Or Community Attachment. (American Indian or Alaska Native)
    C41259 (NCI Thesaurus)
    C1515945 (UMLS 2011AA)
    CL Item
    A Person Having Origins In Any Of The Original Peoples Of The Far East, Southeast Asia, Or The Indian Subcontinent Including, For Example, Cambodia, China, India, Japan, Korea, Malaysia, Pakistan, The Philippine Islands, Thailand, And Vietnam. (Asian)
    C41260 (NCI Thesaurus)
    C0078988 (UMLS 2011AA)
    CL Item
    A Person Having Origins In Any Of The Black Racial Groups Of Africa. Terms Such As "haitian" Or "negro" Can Be Used In Addition To "black Or African American." (Black or African American)
    C16352 (NCI Thesaurus)
    C0085756 (UMLS 2011AA)
    CL Item
    A Person Having Origins In Any Of The Original Peoples Of Hawaii, Guam, Samoa, Or Other Pacific Islands. (Native Hawaiian or other Pacific Islander)
    C41219 (NCI Thesaurus)
    C1513907 (UMLS 2011AA)
    CL Item
    Not Provided Or Available (Not Reported)
    C43234 (NCI Thesaurus)
    C1706613 (UMLS 2011AA)
    CL Item
    Could Not Be Determined Or Unsure (Unknown)
    C17998 (NCI Thesaurus)
    C0439673 (UMLS 2011AA)
    CL Item
    A Person Having Origins In Any Of The Original Peoples Of Europe, The Middle East, Or North Africa. (White)
    C41261 (NCI Thesaurus)
    C0007457 (UMLS 2011AA)
    Item
    Ethnicity (Mark one)
    text
    C25372 (NCI Thesaurus ValueDomain)
    C0683312 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C16564 (NCI Thesaurus Property)
    C0015031 (UMLS 2011AA Property)
    CL.3
    Code List
    Ethnicity (Mark 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 Group
    Patient Demographics/pre-treatment Characteristics2
    Item
    Performance Status (ECOG/Zubrod scale)
    text
    C25664 (NCI Thesaurus ValueDomain)
    C0349674 (UMLS 2011AA ValueDomain)
    C25367 (NCI Thesaurus Property)
    C25491 (NCI Thesaurus ValueDomain)
    C1512162 (UMLS 2011AA ValueDomain)
    C20641 (NCI Thesaurus ObjectClass)
    C1518965 (UMLS 2011AA ObjectClass)
    CL.4
    Code List
    Performance Status (ECOG/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)
    CL Item
    Dead (5)
    PatientHeightMeasurement
    Item
    Height (cm)
    double
    C25209 (NCI Thesaurus ValueDomain)
    C0242485 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25347 (NCI Thesaurus Property)
    C0489786 (UMLS 2011AA Property)
    PatientWeightMeasurement
    Item
    Weight (kg)
    double
    C25209 (NCI Thesaurus ValueDomain)
    C0242485 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25208 (NCI Thesaurus Property)
    C0043100 (UMLS 2011AA Property)
    PatientBodySurfaceAreaMeasurement
    Item
    Body Surface Area (m^2)
    double
    C25209 (NCI Thesaurus ValueDomain)
    C0242485 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25157 (NCI Thesaurus Property)
    C0005902 (UMLS 2011AA Property)
    Item
    Method of Payment (USA only Mark one)
    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.5
    Code List
    Method of Payment (USA only Mark one)
    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 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)
    DiseaseDescriptionText
    Item
    Disease
    text
    C25704 (NCI Thesaurus ValueDomain)
    C1527021 (UMLS 2011AA ValueDomain)
    C2991 (NCI Thesaurus ObjectClass)
    C0012634 (UMLS 2011AA ObjectClass)
    C25365 (NCI Thesaurus Property)
    C0678257 (UMLS 2011AA Property)
    Item
    Stage
    text
    C3262 (NCI Thesaurus ObjectClass)
    C0027651 (UMLS 2011AA ObjectClass)
    C12971 (NCI Thesaurus ObjectClass)
    C0006141 (UMLS 2011AA ObjectClass)
    C16899 (NCI Thesaurus ValueDomain)
    C1300072 (UMLS 2011AA ValueDomain)
    C38027 (NCI Thesaurus Property)
    C1519504 (UMLS 2011AA Property)
    CL.6
    Code List
    Stage
    CL Item
    T0, N1, M0 Or T1*, N1, M0 Or T2, N0, M0 Or T2, N1, M0 Or T3, N0, M0 (II)
    CL Item
    T0, N2, M0 Or T1*, N2, M0 Or T2, N2, M0 Or T3, N1, M0 Or T3, N2, M0 Or T4, N0, M0 Or T4, N1, M0 Or T4, N2, M0 Or Any T, N3, M0 (III)
    DiseasesandDisordersPathologyDescriptionText
    Item
    Pathologic type
    text
    C25704 (NCI Thesaurus ValueDomain)
    C1527021 (UMLS 2011AA ValueDomain)
    C2991 (NCI Thesaurus ObjectClass)
    C0012634 (UMLS 2011AA ObjectClass)
    C18189 (NCI Thesaurus Property)
    C0030664 (UMLS 2011AA Property)
    C25365 (NCI Thesaurus Property)
    C0678257 (UMLS 2011AA Property)
    PatientAddressPostalCode
    Item
    Patient Zip Code
    text
    C25162 (NCI Thesaurus ValueDomain)
    C0805701 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25407 (NCI Thesaurus Property)
    C1442065 (UMLS 2011AA Property)
    PatientAddressCountryName
    Item
    Country of Residence (if not USA)
    text
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25464 (NCI Thesaurus ValueDomain)
    C0454664 (UMLS 2011AA ValueDomain)
    C25407 (NCI Thesaurus Property)
    C1442065 (UMLS 2011AA Property)
    C42614 (NCI Thesaurus ValueDomain)
    C0027365 (UMLS 2011AA ValueDomain)
    Item Group
    Certification Of Eligibility And Protocol Design
    Item
    In the opinion of the investigator, is the patient eligible?
    text
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25171 (NCI Thesaurus Property)
    C0013893 (UMLS 2011AA Property)
    CL.7
    Code List
    In the opinion of the investigator, is the patient eligible?
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    Item Group
    Protocol Design
    Item
    Stratification factors
    text
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    C25320 (NCI Thesaurus ObjectClass)
    C1507394 (UMLS 2011AA ObjectClass)
    C16153 (NCI Thesaurus Property)
    C1514984 (UMLS 2011AA Property)
    CL.8
    Code List
    Stratification factors
    CL Item
    Stage Ii Breast Cancer (Stage II)
    C7768 (NCI Thesaurus)
    C0278486 (UMLS 2011AA)
    CL Item
    Stage Iii Breast Cancer (Stage III)
    C7769 (NCI Thesaurus)
    C0278487 (UMLS 2011AA)
    CL Item
    Er And Pgr Negative (ER and PGR negative)
    CL Item
    Er And/or Pgr Positive (ER and/or PGR positive)
    Item
    Assigned Treatment Arm
    text
    C15368 (NCI Thesaurus ObjectClass)
    C42651 (NCI Thesaurus ObjectClass)
    C0442711 (UMLS 2011AA ObjectClass)
    C32141 (NCI Thesaurus Property)
    C1140618 (UMLS 2011AA Property)
    C25426 (NCI Thesaurus Property)
    C1516050 (UMLS 2011AA Property)
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    CL.9
    Code List
    Assigned Treatment Arm
    CL Item
    Arm 1: Paclitaxel + Trastuzumab + Lapatinib (Arm 1: Paclitaxel + Trastuzumab + Lapatinib)
    CL Item
    Arm 2: Paclitaxel + Trastuzumab (Arm 2: Paclitaxel + Trastuzumab)
    Item Group
    Initial Patient Consent For Specimen Use
    Item
    Patient's Initial Consent given for specimen use for research on the patient's cancer?
    text
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    C15319 (NCI Thesaurus Property)
    C19157 (NCI Thesaurus ObjectClass)
    C0370003 (UMLS 2011AA ObjectClass)
    C25460 (NCI Thesaurus Property)
    C1511481 (UMLS 2011AA Property)
    CL.10
    Code List
    Patient's Initial Consent given for specimen use for research on the patient's cancer?
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    Item
    Patient's initial consent given for specimen use for genetic research relating to the study treatment
    text
    C19157 (NCI Thesaurus ObjectClass)
    C0370003 (UMLS 2011AA ObjectClass)
    C15319 (NCI Thesaurus Property)
    C25648 (NCI Thesaurus Property)
    C0439849 (UMLS 2011AA Property)
    C17938 (NCI Thesaurus Property)
    C0314603 (UMLS 2011AA Property)
    C25460 (NCI Thesaurus Property)
    C1511481 (UMLS 2011AA Property)
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    CL.11
    Code List
    Patient's initial consent given for specimen use for genetic research relating to the study treatment
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    Item
    Patient's Initial Consent given for specimen kept for future use in research to learn about, prevent, or treat cancer
    text
    C25190 (NCI Thesaurus ObjectClass)
    C0027361 (UMLS 2011AA ObjectClass)
    C15319 (NCI Thesaurus Property)
    C9305 (NCI Thesaurus Property)
    C0006826 (UMLS 2011AA Property)
    C19157 (NCI Thesaurus Property)
    C0370003 (UMLS 2011AA Property)
    C25460 (NCI Thesaurus Property)
    C1511481 (UMLS 2011AA Property)
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    CL.12
    Code List
    Patient's Initial Consent given for specimen kept for future use in research to learn about, prevent, or treat cancer
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    Item
    Patient's initial consent given for specimen(s) may be kept for use in research to learn about, prevent, or treat other health problems (for example: diabetes, Alzheimer's disease, or heart disease)
    text
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C17649 (NCI Thesaurus Property)
    C0205394 (UMLS 2011AA Property)
    C2991 (NCI Thesaurus Property)
    C0012634 (UMLS 2011AA Property)
    C15206 (NCI Thesaurus Property)
    C0008972 (UMLS 2011AA Property)
    C25460 (NCI Thesaurus Property)
    C1511481 (UMLS 2011AA Property)
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    CL.13
    Code List
    Patient's initial consent given for specimen(s) may be kept for use in research to learn about, prevent, or treat other health problems (for example: diabetes, Alzheimer's disease, or heart disease)
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    Item
    Patient's initial consent given for further contact regarding specimen?
    text
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C67527 (NCI Thesaurus Property)
    C0016884 (UMLS 2011AA Property)
    C25460 (NCI Thesaurus Property)
    C1511481 (UMLS 2011AA Property)
    C16452 (NCI Thesaurus Property)
    C0009452 (UMLS 2011AA Property)
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    CL.14
    Code List
    Patient's initial consent given for further contact regarding specimen?
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    Item Group
    Tissue Procurement Kit
    SpecimenSubmissionContactPersonIdentifierName
    Item
    Name
    text
    C19157 (NCI Thesaurus ObjectClass)
    C0370003 (UMLS 2011AA ObjectClass)
    C25461 (NCI Thesaurus ObjectClass)
    C0337611 (UMLS 2011AA ObjectClass)
    C25694 (NCI Thesaurus ObjectClass)
    C1515022 (UMLS 2011AA ObjectClass)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    C25191 (NCI Thesaurus ValueDomain)
    C1547383 (UMLS 2011AA ValueDomain)
    SpecimenSubmissionInstitutionName
    Item
    Institution
    text
    C21541 (NCI Thesaurus ObjectClass)
    C0018704 (UMLS 2011AA ObjectClass)
    C19157 (NCI Thesaurus ObjectClass)
    C0370003 (UMLS 2011AA ObjectClass)
    C25694 (NCI Thesaurus ObjectClass)
    C1515022 (UMLS 2011AA ObjectClass)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    C25191 (NCI Thesaurus ValueDomain)
    C1547383 (UMLS 2011AA ValueDomain)
    SpecimenSubmissionInstitutionAddressText
    Item
    Shipping Address
    text
    C21541 (NCI Thesaurus ObjectClass)
    C0018704 (UMLS 2011AA ObjectClass)
    C19157 (NCI Thesaurus ObjectClass)
    C0370003 (UMLS 2011AA ObjectClass)
    C25694 (NCI Thesaurus ObjectClass)
    C1515022 (UMLS 2011AA ObjectClass)
    C25407 (NCI Thesaurus Property)
    C1442065 (UMLS 2011AA Property)
    C25704 (NCI Thesaurus ValueDomain)
    C1527021 (UMLS 2011AA ValueDomain)
    SpecimenSubmissionContactPersonTelephoneNumber
    Item
    Phone
    text
    C19157 (NCI Thesaurus ObjectClass)
    C0370003 (UMLS 2011AA ObjectClass)
    C25461 (NCI Thesaurus ObjectClass)
    C0337611 (UMLS 2011AA ObjectClass)
    C25694 (NCI Thesaurus ObjectClass)
    C1515022 (UMLS 2011AA ObjectClass)
    C40978 (NCI Thesaurus Property)
    C1515258 (UMLS 2011AA Property)
    C25337 (NCI Thesaurus ValueDomain)
    C0237753 (UMLS 2011AA ValueDomain)
    C25395 (NCI Thesaurus ValueDomain)
    C0039457 (UMLS 2011AA ValueDomain)
    SpecimenSubmissionContactPersonFaxNumber
    Item
    FAX
    text
    C19157 (NCI Thesaurus ObjectClass)
    C0370003 (UMLS 2011AA ObjectClass)
    C25461 (NCI Thesaurus ObjectClass)
    C0337611 (UMLS 2011AA ObjectClass)
    C25694 (NCI Thesaurus ObjectClass)
    C1515022 (UMLS 2011AA ObjectClass)
    C42879 (NCI Thesaurus Property)
    C1549619 (UMLS 2011AA Property)
    C25337 (NCI Thesaurus ValueDomain)
    C0237753 (UMLS 2011AA ValueDomain)
    C25395 (NCI Thesaurus ValueDomain)
    C0039457 (UMLS 2011AA ValueDomain)
    SpecimenSubmissionContactPersonE-mailAddressText
    Item
    Email
    text
    C19157 (NCI Thesaurus ObjectClass)
    C0370003 (UMLS 2011AA ObjectClass)
    C25461 (NCI Thesaurus ObjectClass)
    C0337611 (UMLS 2011AA ObjectClass)
    C25694 (NCI Thesaurus ObjectClass)
    C1515022 (UMLS 2011AA ObjectClass)
    C42775 (NCI Thesaurus Property)
    C1705961 (UMLS 2011AA Property)
    C25704 (NCI Thesaurus ValueDomain)
    C1527021 (UMLS 2011AA ValueDomain)
    Item Group
    Registration Information
    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)
    C25646 (NCI Thesaurus Property)
    C1514821 (UMLS 2011AA Property)
    PatientCALGBIdentifierNumber
    Item
    CALGB Patient ID (Assigned)
    text
    C25337 (NCI Thesaurus ValueDomain)
    C0237753 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    C25442 (NCI Thesaurus Property)
    C1516238 (UMLS 2011AA Property)
    PatientParticipatingIdentifierNumber
    Item
    Participating Group Patient ID (Assigned)
    text
    C25337 (NCI Thesaurus ValueDomain)
    C0237753 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25608 (NCI Thesaurus Property)
    C0679823 (UMLS 2011AA Property)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    RegisteringPersonIdentifierSignatureName
    Item
    Registrar's Signature
    text
    C25190 (NCI Thesaurus ObjectClass)
    C0027361 (UMLS 2011AA ObjectClass)
    C25645 (NCI Thesaurus ObjectClass)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    C25191 (NCI Thesaurus ValueDomain)
    C1547383 (UMLS 2011AA ValueDomain)
    C25678 (NCI Thesaurus ValueDomain)
    C1519316 (UMLS 2011AA ValueDomain)
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