ID

43010

Beskrivning

Cyclophosphamide and Doxorubicin (CA x 4 cycles) versus Paclitaxel (4 cycles) as Adjuvant Therapy for Breast Cancer in Women with 0-3 Positive Axillary Lymph Nodes: A 2x2 Factorial Phase III Randomized Study Four Versus Six Cycles of Cyclophosphamide/Doxorubicin or Paclitaxel in Adjuvant Breast Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=36B8E5A6-BC9A-573E-E044-0003BA3F9857

Länk

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=36B8E5A6-BC9A-573E-E044-0003BA3F9857

Nyckelord

  1. 2012-08-26 2012-08-26 -
  2. 2015-01-09 2015-01-09 - Martin Dugas
  3. 2015-01-09 2015-01-09 - Martin Dugas
  4. 2021-09-17 2021-09-17 -
Uppladdad den

17 september 2021

DOI

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Licens

Creative Commons BY-NC 3.0 Legacy

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    Breast Cancer NCT00041119 Registration - CALGB 40101 REGISTRATION WORKSHEET - 2670720v1.0

    No Instruction available.

    1. StudyEvent: CALGB 40101 REGISTRATION WORKSHEET
      1. No Instruction available.
    Header Module
    Beskrivning

    Header Module

    Lead Institution
    Beskrivning

    LeadInstitutionName

    Datatyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS 2011AA ValueDomain
    C1547383
    NCI Thesaurus ObjectClass
    C21541
    UMLS 2011AA ObjectClass
    C0018704
    NCI Thesaurus ValueDomain-2
    C21541
    UMLS 2011AA ValueDomain-2
    C0018704
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    NCI Thesaurus ObjectClass-2
    C25552
    UMLS 2011AA ObjectClass-2
    C1522538
    CALGB Patient ID (Assigned)
    Beskrivning

    Trial subject ID CALGB

    Datatyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C2348585
    NCI Thesaurus ObjectClass
    C16960
    UMLS CUI-2
    C1516238
    NCI Thesaurus Property
    C25364
    NCI Thesaurus Property-2
    C25442
    Institution/Affiliate
    Beskrivning

    Institution Name

    Datatyp

    text

    Alias
    NCI Thesaurus ObjectClass
    C25454
    UMLS CUI-1
    C1301943
    NCI Thesaurus ObjectClass-2
    C21541
    NCI Thesaurus Property
    C25364
    NCI Thesaurus ValueDomain
    C25191
    NCI Thesaurus ValueDomain-2
    C21541
    Physician of Record
    Beskrivning

    Investigator Name

    Datatyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS CUI-1
    C2826892
    NCI Thesaurus Property
    C25364
    NCI Thesaurus ObjectClass
    C17089
    NCI Thesaurus ObjectClass-2
    C25644
    Participating Group Name
    Beskrivning

    Participating Group

    Datatyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS CUI-1
    C2347449
    NCI Thesaurus ObjectClass
    C25608
    NCI Thesaurus ObjectClass-2
    C17005
    NCI Thesaurus Property
    C25364
    Protocol Administration
    Beskrivning

    Protocol Administration

    IRB/REB Approval Date
    Beskrivning

    IRB Approval Date

    Datatyp

    date

    Alias
    NCI Thesaurus ObjectClass
    C25320
    UMLS CUI-1
    C2346500
    NCI Thesaurus Property
    C16741
    NCI Thesaurus Property-2
    C25425
    NCI Thesaurus ValueDomain
    C25164
    NCI Thesaurus ValueDomain-2
    C25367
    Date Informed Consent Signed
    Beskrivning

    InformedConsentFormSignedDate

    Datatyp

    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
    Projected Treatment Begin Date
    Beskrivning

    Treatment Begin Date

    Datatyp

    date

    Alias
    NCI Thesaurus ObjectClass
    C15368
    NCI Thesaurus ObjectClass-2
    C25631
    NCI Thesaurus Property
    C25431
    UMLS CUI-1
    C3173309
    NCI Thesaurus Property-2
    C25275
    NCI Thesaurus ValueDomain
    C25164
    NCI Thesaurus ValueDomain-2
    C25431
    HIPAA Authorization Date
    Beskrivning

    PatientSignedDischargeMedicalRecordDate

    Datatyp

    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
    Contact Person at Institution
    Beskrivning

    InstitutionContactPersonName

    Datatyp

    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-2
    C25461
    UMLS 2011AA ObjectClass-2
    C0337611
    Phone
    Beskrivning

    Person Completing Form Phone

    Datatyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C1550483
    NCI Thesaurus ObjectClass
    C25190
    UMLS CUI-2
    C1515258
    NCI Thesaurus ObjectClass-2
    C25657
    NCI Thesaurus Property
    C25395
    Fax
    Beskrivning

    ResponsiblePersonFaxNumber

    Datatyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS 2011AA ValueDomain
    C0237753
    NCI Thesaurus ObjectClass
    C25190
    UMLS 2011AA ObjectClass
    C0027361
    NCI Thesaurus ObjectClass-2
    C25657
    UMLS 2011AA ObjectClass-2
    C1273518
    NCI Thesaurus Property
    C25210
    UMLS 2011AA Property
    C0085205
    Patient Demographics/pre-treatment Characteristics
    Beskrivning

    Patient Demographics/pre-treatment Characteristics

    Last
    Beskrivning

    Patient Initials Last

    Datatyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS CUI-1
    C2986440
    NCI Thesaurus ObjectClass
    C16960
    UMLS CUI-2
    C1517741
    NCI Thesaurus Property
    C25536
    NCI Thesaurus Property-2
    C25551
    First
    Beskrivning

    Patient Initials First

    Datatyp

    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
    Beskrivning

    PatientMiddleInitialsName

    Datatyp

    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
    Patient Social Security Number
    Beskrivning

    PatientPersonSocialSecurityNumber

    Datatyp

    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 Birth Date (MM DD YYYY)
    Beskrivning

    Patient Birth Date

    Datatyp

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS CUI-1
    C0421451
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus ValueDomain-2
    C25367
    NCI Thesaurus Property
    C25155
    Patient Hospital No.
    Beskrivning

    Medical Record Number

    Datatyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C1301894
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25261
    NCI Thesaurus Property-2
    C25198
    Gender
    Beskrivning

    Gender

    Datatyp

    text

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

    Racial Group

    Datatyp

    text

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

    Ethnic Group

    Datatyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25372
    UMLS CUI-1
    C0015031
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C16564
    ECOG Performance Status
    Beskrivning

    ECOG Performance Status

    Datatyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25664
    UMLS CUI-1
    C1520224
    NCI Thesaurus Property
    C25367
    NCI Thesaurus ValueDomain-2
    C25491
    NCI Thesaurus ObjectClass
    C20641
    Height (cm)
    Beskrivning

    Patient Height

    Datatyp

    float

    Måttenheter
    • cm
    Alias
    NCI Thesaurus ValueDomain
    C25209
    UMLS CUI-1
    C0489786
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25347
    cm
    Weight (kg)
    Beskrivning

    Patient Weight

    Datatyp

    float

    Måttenheter
    • Kg
    Alias
    NCI Thesaurus ValueDomain
    C25209
    UMLS CUI-1
    C0005910
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25208
    Kg
    BSA (m^2)
    Beskrivning

    Body Surface Area

    Datatyp

    float

    Måttenheter
    • m2
    Alias
    NCI Thesaurus ObjectClass
    C25190
    UMLS CUI-1
    C0005902
    NCI Thesaurus ValueDomain
    C25712
    NCI Thesaurus Property
    C25157
    m2
    Method of Payment
    Beskrivning

    PatientPaymentType

    Datatyp

    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
    Patient Zip Code
    Beskrivning

    PatientAddressPostalCode

    Datatyp

    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)
    Beskrivning

    Country of current residence

    Datatyp

    text

    Alias
    NCI Thesaurus ObjectClass
    C16960
    UMLS CUI-1
    C3258975
    NCI Thesaurus ValueDomain
    C25464
    NCI Thesaurus Property
    C25407
    NCI Thesaurus ValueDomain-2
    C42614
    Certification Of Eligibility And Protocol Design
    Beskrivning

    Certification Of Eligibility And Protocol Design

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

    Eligibility for trial

    Datatyp

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS CUI-1
    C1302261
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25171
    Menopausal status
    Beskrivning

    PatientMenopauseStatus

    Datatyp

    text

    Alias
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C3231
    UMLS 2011AA Property
    C0025320
    NCI Thesaurus ValueDomain
    C25688
    UMLS 2011AA ValueDomain
    C0449438
    ER/PgR
    Beskrivning

    ProtocolEstrogenReceptorStatusProgesteroneReceptorStatusStratificationFactorsStatus

    Datatyp

    text

    Alias
    NCI Thesaurus ObjectClass
    C25320
    UMLS 2011AA ObjectClass
    C1507394
    NCI Thesaurus Property
    C16149
    UMLS 2011AA Property
    C1514471
    NCI Thesaurus Property-2
    C16150
    UMLS 2011AA Property-2
    C1516974
    NCI Thesaurus Property-3
    C16153
    UMLS 2011AA Property-3
    C1514984
    NCI Thesaurus ValueDomain
    C25688
    UMLS 2011AA ValueDomain
    C0449438
    HER-2/neu status
    Beskrivning

    HER2/neuStatusType

    Datatyp

    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
    Assigned Treatment Arm
    Beskrivning

    Protocol Treatment Arm

    Datatyp

    text

    Alias
    NCI Thesaurus ObjectClass
    C15368
    NCI Thesaurus ObjectClass-2
    C42651
    UMLS CUI-1
    C1522541
    NCI Thesaurus Property
    C32141
    NCI Thesaurus Property-2
    C25426
    NCI Thesaurus ValueDomain
    C25284
    Initial Patient Consent For Specimen Use
    Beskrivning

    Initial Patient Consent For Specimen Use

    Is the patient registering to the Pharmacogenetic companion study 60202 (titled "Drug Metabolism and Transport PG in Breast CA")?
    Beskrivning

    PatientCancerandLeukemiaGroupBClinicalStudyMetabolicPathwayEnrollmentInd-2

    Datatyp

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C25442
    UMLS 2011AA Property
    C1516238
    NCI Thesaurus Property-2
    C15206
    UMLS 2011AA Property-2
    C0008972
    NCI Thesaurus Property-3
    C37948
    UMLS 2011AA Property-3
    C1516879
    NCI Thesaurus Property-4
    C18611
    UMLS 2011AA Property-4
    C1291081
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    Patient's initial consent given for blood specimen use for genetic research on patient's cancer?
    Beskrivning

    BloodSpecimenRelatedGeneticResearchConsentInd-2

    Datatyp

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C12434
    UMLS 2011AA ObjectClass
    C0229664
    NCI Thesaurus ObjectClass-2
    C19157
    UMLS 2011AA ObjectClass-2
    C0370003
    NCI Thesaurus Property
    C15319
    NCI Thesaurus Property-2
    C25648
    UMLS 2011AA Property
    C0439849
    NCI Thesaurus Property-3
    C17938
    UMLS 2011AA Property-2
    C0314603
    NCI Thesaurus Property-4
    C25460
    UMLS 2011AA Property-3
    C1511481
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    Did patient consent to DNA specimen use in future research studies?
    Beskrivning

    SpecimenRelatedGeneticFutureResearchConsentInd-2

    Datatyp

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C19157
    UMLS 2011AA ObjectClass
    C0370003
    NCI Thesaurus Property
    C15319
    NCI Thesaurus Property-2
    C67527
    UMLS 2011AA Property
    C0016884
    NCI Thesaurus Property-3
    C17938
    UMLS 2011AA Property-2
    C0314603
    NCI Thesaurus Property-4
    C25460
    UMLS 2011AA Property-3
    C1511481
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    Patient's Initial Consent given for tissue specimen use for research on the patient's cancer?
    Beskrivning

    TissueSpecimenMalignantNeoplasmRelatedResearchConsentInd-3

    Datatyp

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C12801
    UMLS 2011AA ObjectClass
    C0040300
    NCI Thesaurus ObjectClass-2
    C19157
    UMLS 2011AA ObjectClass-2
    C0370003
    NCI Thesaurus Property
    C15319
    NCI Thesaurus Property-2
    C25648
    UMLS 2011AA Property
    C0439849
    NCI Thesaurus Property-3
    C9305
    UMLS 2011AA Property-2
    C0006826
    NCI Thesaurus Property-4
    C25460
    UMLS 2011AA Property-3
    C1511481
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    Patient's Initial Consent given for tissue specimen use for research unrelated to the patient's cancer?
    Beskrivning

    TissueSpecimenResearchConsentUnrelatedInd-3

    Datatyp

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C12801
    UMLS 2011AA ObjectClass
    C0040300
    NCI Thesaurus ObjectClass-2
    C19157
    UMLS 2011AA ObjectClass-2
    C0370003
    NCI Thesaurus Property
    C15319
    NCI Thesaurus Property-2
    C25460
    UMLS 2011AA Property
    C1511481
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    NCI Thesaurus ValueDomain-2
    C25328
    UMLS 2011AA ValueDomain-2
    C0445356
    Patient's initial consent given for further contact regarding specimen?
    Beskrivning

    Permission to contact Patient

    Datatyp

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C16960
    UMLS CUI-1
    C1522577
    NCI Thesaurus Property
    C67527
    UMLS CUI-2
    C0521104
    NCI Thesaurus Property-2
    C25460
    NCI Thesaurus Property-3
    C16452
    NCI Thesaurus ValueDomain
    C38148
    Registration Information
    Beskrivning

    Registration Information

    CALGB Patient ID (Assigned)
    Beskrivning

    Trial subject ID CALGB

    Datatyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C2348585
    NCI Thesaurus ObjectClass
    C16960
    UMLS CUI-2
    C1516238
    NCI Thesaurus Property
    C25364
    NCI Thesaurus Property-2
    C25442
    Date of Registration
    Beskrivning

    PatientRegistrationDate

    Datatyp

    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
    Participating Group Patient ID (Assigned)
    Beskrivning

    Trial subject ID Participating Group

    Datatyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C2348585
    NCI Thesaurus ObjectClass
    C16960
    UMLS CUI-2
    C2347449
    NCI Thesaurus Property
    C25608
    NCI Thesaurus Property-2
    C25364
    Registrar's Signature
    Beskrivning

    RegisteringPersonIdentifierSignatureName

    Datatyp

    text

    Alias
    NCI Thesaurus ObjectClass
    C25190
    UMLS 2011AA ObjectClass
    C0027361
    NCI Thesaurus ObjectClass-2
    C25645
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    NCI Thesaurus ValueDomain
    C25191
    UMLS 2011AA ValueDomain
    C1547383
    NCI Thesaurus ValueDomain-2
    C25678
    UMLS 2011AA ValueDomain-2
    C1519316

    Similar models

    No Instruction available.

    1. StudyEvent: CALGB 40101 REGISTRATION WORKSHEET
      1. No Instruction available.
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    Header Module
    LeadInstitutionName
    Item
    Lead Institution
    text
    C25191 (NCI Thesaurus ValueDomain)
    C1547383 (UMLS 2011AA ValueDomain)
    C21541 (NCI Thesaurus ObjectClass)
    C0018704 (UMLS 2011AA ObjectClass)
    C21541 (NCI Thesaurus ValueDomain-2)
    C0018704 (UMLS 2011AA ValueDomain-2)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    C25552 (NCI Thesaurus ObjectClass-2)
    C1522538 (UMLS 2011AA ObjectClass-2)
    Trial subject ID CALGB
    Item
    CALGB Patient ID (Assigned)
    text
    C25337 (NCI Thesaurus ValueDomain)
    C2348585 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C1516238 (UMLS CUI-2)
    C25364 (NCI Thesaurus Property)
    C25442 (NCI Thesaurus Property-2)
    Institution Name
    Item
    Institution/Affiliate
    text
    C25454 (NCI Thesaurus ObjectClass)
    C1301943 (UMLS CUI-1)
    C21541 (NCI Thesaurus ObjectClass-2)
    C25364 (NCI Thesaurus Property)
    C25191 (NCI Thesaurus ValueDomain)
    C21541 (NCI Thesaurus ValueDomain-2)
    Investigator Name
    Item
    Physician of Record
    text
    C25191 (NCI Thesaurus ValueDomain)
    C2826892 (UMLS CUI-1)
    C25364 (NCI Thesaurus Property)
    C17089 (NCI Thesaurus ObjectClass)
    C25644 (NCI Thesaurus ObjectClass-2)
    Participating Group
    Item
    Participating Group Name
    text
    C25191 (NCI Thesaurus ValueDomain)
    C2347449 (UMLS CUI-1)
    C25608 (NCI Thesaurus ObjectClass)
    C17005 (NCI Thesaurus ObjectClass-2)
    C25364 (NCI Thesaurus Property)
    Item Group
    Protocol Administration
    IRB Approval Date
    Item
    IRB/REB Approval Date
    date
    C25320 (NCI Thesaurus ObjectClass)
    C2346500 (UMLS CUI-1)
    C16741 (NCI Thesaurus Property)
    C25425 (NCI Thesaurus Property-2)
    C25164 (NCI Thesaurus ValueDomain)
    C25367 (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)
    Treatment Begin Date
    Item
    Projected Treatment Begin Date
    date
    C15368 (NCI Thesaurus ObjectClass)
    C25631 (NCI Thesaurus ObjectClass-2)
    C25431 (NCI Thesaurus Property)
    C3173309 (UMLS CUI-1)
    C25275 (NCI Thesaurus Property-2)
    C25164 (NCI Thesaurus ValueDomain)
    C25431 (NCI Thesaurus ValueDomain-2)
    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-2)
    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-2)
    C0337611 (UMLS 2011AA ObjectClass-2)
    Person Completing Form Phone
    Item
    Phone
    text
    C25337 (NCI Thesaurus ValueDomain)
    C1550483 (UMLS CUI-1)
    C25190 (NCI Thesaurus ObjectClass)
    C1515258 (UMLS CUI-2)
    C25657 (NCI Thesaurus ObjectClass-2)
    C25395 (NCI Thesaurus Property)
    ResponsiblePersonFaxNumber
    Item
    Fax
    text
    C25337 (NCI Thesaurus ValueDomain)
    C0237753 (UMLS 2011AA ValueDomain)
    C25190 (NCI Thesaurus ObjectClass)
    C0027361 (UMLS 2011AA ObjectClass)
    C25657 (NCI Thesaurus ObjectClass-2)
    C1273518 (UMLS 2011AA ObjectClass-2)
    C25210 (NCI Thesaurus Property)
    C0085205 (UMLS 2011AA Property)
    Item Group
    Patient Demographics/pre-treatment Characteristics
    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)
    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)
    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)
    Patient Birth Date
    Item
    Patient Birth Date (MM DD YYYY)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0421451 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C25367 (NCI Thesaurus ValueDomain-2)
    C25155 (NCI Thesaurus Property)
    Medical Record Number
    Item
    Patient Hospital No.
    text
    C25337 (NCI Thesaurus ValueDomain)
    C1301894 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C25261 (NCI Thesaurus Property)
    C25198 (NCI Thesaurus Property-2)
    Item
    Gender
    text
    C25372 (NCI Thesaurus ValueDomain)
    C0079399 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C17357 (NCI Thesaurus Property)
    Code List
    Gender
    CL Item
    Female (FEMALE)
    C46110 (NCI Thesaurus)
    C0086287 (UMLS 2011AA)
    CL Item
    Male (MALE)
    C46109 (NCI Thesaurus)
    C1706180 (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)
    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
    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)
    C0015031 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C16564 (NCI Thesaurus Property)
    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
    ECOG Performance Status
    text
    C25664 (NCI Thesaurus ValueDomain)
    C1520224 (UMLS CUI-1)
    C25367 (NCI Thesaurus Property)
    C25491 (NCI Thesaurus ValueDomain-2)
    C20641 (NCI Thesaurus ObjectClass)
    Code List
    ECOG Performance Status
    CL Item
    Fully Active, Able To Carry On All Pre-disease Performance Without Restriction. (0)
    CL Item
    Restricted In Physically Strenuous Activity But Ambulatory And Able To Carry Out Work Of A Light Or Sedentary Nature, E.g., Light Housework, Office Work. (1)
    CL Item
    Ambulatory And Capable Of All Selfcare But Unable To Carry Out Any Work Activities. Up And About More Than 50% Of Waking Hours. (2)
    CL Item
    Capable Of Only Limited Selfcare, Confined To Bed Or Chair More Than 50% Of Waking Hours. (3)
    CL Item
    Completely Disabled. Cannot Carry On Any Selfcare. Totally Confined To Bed Or Chair. (4)
    CL Item
    Dead (5)
    Patient Height
    Item
    Height (cm)
    float
    C25209 (NCI Thesaurus ValueDomain)
    C0489786 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C25347 (NCI Thesaurus Property)
    Patient Weight
    Item
    Weight (kg)
    float
    C25209 (NCI Thesaurus ValueDomain)
    C0005910 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C25208 (NCI Thesaurus Property)
    Body Surface Area
    Item
    BSA (m^2)
    float
    C25190 (NCI Thesaurus ObjectClass)
    C0005902 (UMLS CUI-1)
    C25712 (NCI Thesaurus ValueDomain)
    C25157 (NCI Thesaurus Property)
    Item
    Method of Payment
    text
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25371 (NCI Thesaurus Property)
    C0680264 (UMLS 2011AA Property)
    Code List
    Method of Payment
    CL Item
    Medicaid (Medicaid)
    C0025071 (NCI Metathesaurus)
    CL Item
    Medicaid And Medicare (Medicaid and Medicare)
    CL Item
    Medicare (Medicare)
    C16665 (NCI Thesaurus)
    C0018717 (UMLS 2011AA)
    CL Item
    Medicare And Private Insurance (Medicare and Private Insurance)
    CL Item
    Military 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)
    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)
    Country of current residence
    Item
    Country of Residence (if not USA)
    text
    C16960 (NCI Thesaurus ObjectClass)
    C3258975 (UMLS CUI-1)
    C25464 (NCI Thesaurus ValueDomain)
    C25407 (NCI Thesaurus Property)
    C42614 (NCI Thesaurus ValueDomain-2)
    Item Group
    Certification Of Eligibility And Protocol Design
    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)
    Item
    Menopausal status
    text
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C3231 (NCI Thesaurus Property)
    C0025320 (UMLS 2011AA Property)
    C25688 (NCI Thesaurus ValueDomain)
    C0449438 (UMLS 2011AA ValueDomain)
    Code List
    Menopausal status
    CL Item
    Postmenopausal (Postmenopausal)
    C15421 (NCI Thesaurus)
    C0232970 (UMLS 2011AA)
    C15421 (NCI Thesaurus-3)
    C0232970 (UMLS 2011AA-4)
    C15421 (NCI Thesaurus-5)
    C0232970 (UMLS 2011AA-6)
    CL Item
    Premenopausal (Premenopausal)
    C15491 (NCI Thesaurus)
    C0279752 (UMLS 2011AA)
    Item
    ER/PgR
    text
    C25320 (NCI Thesaurus ObjectClass)
    C1507394 (UMLS 2011AA ObjectClass)
    C16149 (NCI Thesaurus Property)
    C1514471 (UMLS 2011AA Property)
    C16150 (NCI Thesaurus Property-2)
    C1516974 (UMLS 2011AA Property-2)
    C16153 (NCI Thesaurus Property-3)
    C1514984 (UMLS 2011AA Property-3)
    C25688 (NCI Thesaurus ValueDomain)
    C0449438 (UMLS 2011AA ValueDomain)
    Code List
    ER/PgR
    CL Item
    Both Negative (Both negative)
    CL Item
    Both Or Either Positive Or Unknown (Both or either positive or unknown)
    Item
    HER-2/neu status
    text
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    C17756 (NCI Thesaurus ObjectClass)
    C0242957 (UMLS 2011AA ObjectClass)
    C25365 (NCI Thesaurus Property)
    C0678257 (UMLS 2011AA Property)
    Code List
    HER-2/neu status
    CL Item
    Negative (Negative)
    C25247 (NCI Thesaurus)
    C0205160 (UMLS 2011AA)
    CL Item
    Positive (Positive)
    C25246 (NCI Thesaurus)
    C1446409 (UMLS 2011AA)
    CL Item
    Unknown (Unknown)
    C17998 (NCI Thesaurus)
    C0439673 (UMLS 2011AA)
    Item
    Assigned Treatment Arm
    text
    C15368 (NCI Thesaurus ObjectClass)
    C42651 (NCI Thesaurus ObjectClass-2)
    C1522541 (UMLS CUI-1)
    C32141 (NCI Thesaurus Property)
    C25426 (NCI Thesaurus Property-2)
    C25284 (NCI Thesaurus ValueDomain)
    Code List
    Assigned Treatment Arm
    CL Item
    Ca Therapy -- 4 Cycles (c-600 Mg/m2 A-60 Mg/m2 Q-14 Days) (CA Therapy -- 4 cycles (C-600 mg/m2 A-60 mg/m2 q-14 days))
    CL Item
    Paclitaxel -- 4 Cycles (175 Mg/m2 Q-14 Days) (Paclitaxel -- 4 cycles (175 mg/m2 q-14 days))
    Item Group
    Initial Patient Consent For Specimen Use
    PatientCancerandLeukemiaGroupBClinicalStudyMetabolicPathwayEnrollmentInd-2
    Item
    Is the patient registering to the Pharmacogenetic companion study 60202 (titled "Drug Metabolism and Transport PG in Breast CA")?
    boolean
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25442 (NCI Thesaurus Property)
    C1516238 (UMLS 2011AA Property)
    C15206 (NCI Thesaurus Property-2)
    C0008972 (UMLS 2011AA Property-2)
    C37948 (NCI Thesaurus Property-3)
    C1516879 (UMLS 2011AA Property-3)
    C18611 (NCI Thesaurus Property-4)
    C1291081 (UMLS 2011AA Property-4)
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    BloodSpecimenRelatedGeneticResearchConsentInd-2
    Item
    Patient's initial consent given for blood specimen use for genetic research on patient's cancer?
    boolean
    C12434 (NCI Thesaurus ObjectClass)
    C0229664 (UMLS 2011AA ObjectClass)
    C19157 (NCI Thesaurus ObjectClass-2)
    C0370003 (UMLS 2011AA ObjectClass-2)
    C15319 (NCI Thesaurus Property)
    C25648 (NCI Thesaurus Property-2)
    C0439849 (UMLS 2011AA Property)
    C17938 (NCI Thesaurus Property-3)
    C0314603 (UMLS 2011AA Property-2)
    C25460 (NCI Thesaurus Property-4)
    C1511481 (UMLS 2011AA Property-3)
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    SpecimenRelatedGeneticFutureResearchConsentInd-2
    Item
    Did patient consent to DNA specimen use in future research studies?
    boolean
    C19157 (NCI Thesaurus ObjectClass)
    C0370003 (UMLS 2011AA ObjectClass)
    C15319 (NCI Thesaurus Property)
    C67527 (NCI Thesaurus Property-2)
    C0016884 (UMLS 2011AA Property)
    C17938 (NCI Thesaurus Property-3)
    C0314603 (UMLS 2011AA Property-2)
    C25460 (NCI Thesaurus Property-4)
    C1511481 (UMLS 2011AA Property-3)
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    TissueSpecimenMalignantNeoplasmRelatedResearchConsentInd-3
    Item
    Patient's Initial Consent given for tissue specimen use for research on the patient's cancer?
    boolean
    C12801 (NCI Thesaurus ObjectClass)
    C0040300 (UMLS 2011AA ObjectClass)
    C19157 (NCI Thesaurus ObjectClass-2)
    C0370003 (UMLS 2011AA ObjectClass-2)
    C15319 (NCI Thesaurus Property)
    C25648 (NCI Thesaurus Property-2)
    C0439849 (UMLS 2011AA Property)
    C9305 (NCI Thesaurus Property-3)
    C0006826 (UMLS 2011AA Property-2)
    C25460 (NCI Thesaurus Property-4)
    C1511481 (UMLS 2011AA Property-3)
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    TissueSpecimenResearchConsentUnrelatedInd-3
    Item
    Patient's Initial Consent given for tissue specimen use for research unrelated to the patient's cancer?
    boolean
    C12801 (NCI Thesaurus ObjectClass)
    C0040300 (UMLS 2011AA ObjectClass)
    C19157 (NCI Thesaurus ObjectClass-2)
    C0370003 (UMLS 2011AA ObjectClass-2)
    C15319 (NCI Thesaurus Property)
    C25460 (NCI Thesaurus Property-2)
    C1511481 (UMLS 2011AA Property)
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    C25328 (NCI Thesaurus ValueDomain-2)
    C0445356 (UMLS 2011AA ValueDomain-2)
    Permission to contact Patient
    Item
    Patient's initial consent given for further contact regarding specimen?
    boolean
    C16960 (NCI Thesaurus ObjectClass)
    C1522577 (UMLS CUI-1)
    C67527 (NCI Thesaurus Property)
    C0521104 (UMLS CUI-2)
    C25460 (NCI Thesaurus Property-2)
    C16452 (NCI Thesaurus Property-3)
    C38148 (NCI Thesaurus ValueDomain)
    Item Group
    Registration Information
    Trial subject ID CALGB
    Item
    CALGB Patient ID (Assigned)
    text
    C25337 (NCI Thesaurus ValueDomain)
    C2348585 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C1516238 (UMLS CUI-2)
    C25364 (NCI Thesaurus Property)
    C25442 (NCI Thesaurus Property-2)
    PatientRegistrationDate
    Item
    Date of Registration
    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)
    Trial subject ID Participating Group
    Item
    Participating Group Patient ID (Assigned)
    text
    C25337 (NCI Thesaurus ValueDomain)
    C2348585 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C2347449 (UMLS CUI-2)
    C25608 (NCI Thesaurus Property)
    C25364 (NCI Thesaurus Property-2)
    RegisteringPersonIdentifierSignatureName
    Item
    Registrar's Signature
    text
    C25190 (NCI Thesaurus ObjectClass)
    C0027361 (UMLS 2011AA ObjectClass)
    C25645 (NCI Thesaurus ObjectClass-2)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    C25191 (NCI Thesaurus ValueDomain)
    C1547383 (UMLS 2011AA ValueDomain)
    C25678 (NCI Thesaurus ValueDomain-2)
    C1519316 (UMLS 2011AA ValueDomain-2)

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