ID

904

Description

NSABP Protocol B-40 - Registration Form A Randomized Phase III Trial of Neoadjuvant Therapy in Patients With Palpable and Operable Breast Cancer Evaluating the Effect on Pathologic Complete Response (pCR) of Adding Capecitabine or Gemcitabine to Docetaxel When Administered Before AC With or Without Bevacizumab and Correlative Science Studies Attempting to Identify Predictors of High Likelihood for pCR With Each of the Regimens Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=1B0F2A23-99E0-5C6F-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=1B0F2A23-99E0-5C6F-E044-0003BA3F9857

Keywords

Versions (4)
  1. 8/26/12 8/26/12 -
  2. 1/9/15 1/9/15 - Martin Dugas
  3. 7/3/15 7/3/15 -
  4. 8/4/15 8/4/15 - Martin Dugas
Uploaded on

August 26, 2012

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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    Breast Cancer NCT00408408 Registration - NSABP Protocol B-40 - Registration Form - 2506613v1.0

    English

    Submit every 6 months from date of randomization for the first 5 years; yearly thereafter, and when a protocol event occurs. Fax Form F to 412-622-2111

    1 forms  
    Unnamed1
    Description

    Unnamed1

    Patient Initials (Last First Middle)
    Description

    PatientInitialsName

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS 2011AA ValueDomain
    C1547383
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C25536
    UMLS 2011AA Property
    C1555582
    NSABP Patient ID
    Description

    PatientNationalSurgicalAdjuvantBreastProjectIdentifierNumber

    Data type

    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
    C15818
    UMLS 2011AA Property
    C1513905
    Unnamed2
    Description

    Unnamed2

    Institution/Affiliate
    Description

    CombinedInstitutionName

    Data type

    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
    Physician of Record
    Description

    RegisteredInvestigatorName

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS 2011AA ValueDomain
    C1547383
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    NCI Thesaurus ObjectClass
    C17089
    UMLS 2011AA ObjectClass
    C0035173
    NCI Thesaurus ObjectClass
    C25644
    Date Informed Consent Signed
    Description

    InformedConsentFormSignedDate

    Data type

    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
    Person Completing Form, Last Name
    Description

    ResponsiblePersonLastName

    Data type

    text

    Alias
    NCI Thesaurus ObjectClass
    C25190
    UMLS 2011AA ObjectClass
    C0027361
    NCI Thesaurus ObjectClass
    C25657
    UMLS 2011AA ObjectClass
    C1273518
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    NCI Thesaurus Property
    C25551
    UMLS 2011AA Property
    C1517741
    NCI Thesaurus ValueDomain
    C25191
    UMLS 2011AA ValueDomain
    C1547383
    Person Completing Form, First Name
    Description

    ResponsiblePersonFirstName

    Data type

    text

    Alias
    NCI Thesaurus ObjectClass
    C25190
    UMLS 2011AA ObjectClass
    C0027361
    NCI Thesaurus ObjectClass
    C25657
    UMLS 2011AA ObjectClass
    C1273518
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    NCI Thesaurus Property
    C25509
    UMLS 2011AA Property
    C1279901
    NCI Thesaurus ValueDomain
    C25191
    UMLS 2011AA ValueDomain
    C1547383
    Person Completing Form, Phone
    Description

    ResponsiblePersonPhoneNumber

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS 2011AA ValueDomain
    C0237753
    NCI Thesaurus ObjectClass
    C25190
    UMLS 2011AA ObjectClass
    C0027361
    NCI Thesaurus ObjectClass
    C25657
    UMLS 2011AA ObjectClass
    C1273518
    NCI Thesaurus Property
    C25395
    UMLS 2011AA Property
    C0039457
    Person Completing Form, Fax
    Description

    ResponsiblePersonFaxNumber

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS 2011AA ValueDomain
    C0237753
    NCI Thesaurus ObjectClass
    C25190
    UMLS 2011AA ObjectClass
    C0027361
    NCI Thesaurus ObjectClass
    C25657
    UMLS 2011AA ObjectClass
    C1273518
    NCI Thesaurus Property
    C25210
    UMLS 2011AA Property
    C0085205
    Unnamed3
    Description

    Unnamed3

    Patient's Date of Birth
    Description

    PatientBirthDate

    Data type

    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 (USA only)
    Description

    PatientPersonSocialSecurityNumber

    Data type

    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
    Person Completing Form, Last Name
    Description

    Person Completing Form, Last Name

    Race (more than one may be marked)
    Description

    PatientRaceCategory

    Data type

    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
    Method of Payment (mark primary method only)
    Description

    PatientPaymentType

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C25371
    UMLS 2011AA Property
    C0680264
    Ethnicity
    Description

    PatientEthnicGroupCategory

    Data type

    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
    Country of Residence (if not USA)
    Description

    PatientAddressCountryCode

    Data type

    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
    Description

    PatientAddressCountryName

    Data type

    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
    Patient Zip Code (USA)
    Description

    PatientAddressPostalCode

    Data type

    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
    How Did The Patient Answer The Following Questions On The Consent Form
    Description

    How Did The Patient Answer The Following Questions On The Consent Form

    I agree to have blood samples collected three times during this study (These samples will be sent to the NSABP.)
    Description

    BloodSpecimenCollectedInd-3

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    NCI Thesaurus ObjectClass
    C12434
    UMLS 2011AA ObjectClass
    C0229664
    NCI Thesaurus ObjectClass
    C19157
    UMLS 2011AA ObjectClass
    C0370003
    NCI Thesaurus Property
    C25452
    My study doctor (or somone he or she shooses) may contact me in the future to ask me to take part in more research. (My study doctor or someone he or she chooses may contact me in the future to ask me to take part in more research.)
    Description

    PatientContactConsentInd-2

    Data type

    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
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    Unnamed5
    Description

    Unnamed5

    Patient Height (cm)
    Description

    PatientHeightMeasurement

    Data type

    double

    Measurement units
    • 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
    Patient Weight (kg)
    Description

    PatientWeightMeasurement

    Data type

    double

    Measurement units
    • 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
    Stratification Factors
    Description

    Stratification Factors

    Lymph Node Involvement
    Description

    LymphNodeInvolvementType

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    NCI Thesaurus ObjectClass
    C12745
    UMLS 2011AA ObjectClass
    C0024204
    NCI Thesaurus Property
    C25547
    Receptor Status
    Description

    BreastHormoneReceptorTumorMarkerFinalDiagnosisResultType

    Data type

    text

    Alias
    NCI Thesaurus ObjectClass
    C12971
    UMLS 2011AA ObjectClass
    C0006141
    NCI Thesaurus ObjectClass
    C17220
    UMLS 2011AA ObjectClass
    C0041365
    NCI Thesaurus ObjectClass
    C28154
    UMLS 2011AA ObjectClass
    C0019929
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    NCI Thesaurus Property
    C15220
    UMLS 2011AA Property
    C0011900
    NCI Thesaurus Property
    C25508
    UMLS 2011AA Property
    C0205088
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    Age
    Description

    PatientAgeYearCount

    Data type

    double

    Alias
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus ValueDomain
    C29848
    UMLS 2011AA ValueDomain
    C0439234
    NCI Thesaurus ValueDomain
    C25463
    UMLS 2011AA ValueDomain
    C0750480
    NCI Thesaurus Property
    C25150
    UMLS 2011AA Property
    C0001779
    Unnamed4
    Description

    Unnamed4

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

    PatientEligibilityIndicator

    Data type

    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
    Has the patient authorized the release of Protected Health Information to the NSABP?
    Description

    PatientPHIConsentIndicator

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25180
    UMLS 2011AA ValueDomain
    C1522602
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C25460
    UMLS 2011AA Property
    C1511481
    Diagnostic Core Needle Biopsy
    Description

    Diagnostic Core Needle Biopsy

    Date of procedure (Date of procedure)
    Description

    SurgicalProcedureCoreBiopsyPerformedDate

    Data type

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus Property
    C15680
    UMLS 2011AA Property
    C1318309
    NCI Thesaurus Property
    C38000
    UMLS 2011AA Property
    C0884358
    NCI Thesaurus ObjectClass
    C15329
    UMLS 2011AA ObjectClass
    C0543467
    Institutional surgical pathology number (core needle biopsy)
    Description

    ProfessionalOrganizationSurgicalPathologyIdentifierNumber

    Data type

    text

    Alias
    NCI Thesaurus ObjectClass
    C19711
    UMLS 2011AA ObjectClass
    C1522486
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    NCI Thesaurus Property
    C25698
    NCI Thesaurus Property
    C18189
    UMLS 2011AA Property
    C0030664
    NCI Thesaurus ValueDomain
    C25337
    UMLS 2011AA ValueDomain
    C0237753
    Core Biopsy Specimens For B-40 Correlative Studies
    Description

    Core Biopsy Specimens For B-40 Correlative Studies

    Date Specimen collected
    Description

    SpecimenCollectedDate

    Data type

    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
    C25275
    UMLS 2011AA Property
    C2745955
    PTI Control Number
    Description

    AgentIdentifierPTINumber

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS 2011AA ValueDomain
    C0237753
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    NCI Thesaurus ObjectClass
    C1708
    UMLS 2011AA ObjectClass
    C0450442
    Target Lesions
    Description

    Target Lesions

    Date of Assessment
    Description

    AssessmentPerformedDate

    Data type

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ObjectClass
    C25367
    NCI Thesaurus ValueDomain
    C25367
    NCI Thesaurus Property
    C38000
    UMLS 2011AA Property
    C0884358
    Number of Target Lesions
    Description

    TargetLesionPresentCount

    Data type

    double

    Alias
    NCI Thesaurus ObjectClass
    C3824
    UMLS 2011AA ObjectClass
    C0221198
    NCI Thesaurus Property
    C25626
    UMLS 2011AA Property
    C0150312
    NCI Thesaurus ValueDomain
    C25463
    UMLS 2011AA ValueDomain
    C0750480
    NCI Thesaurus ObjectClass
    C25702
    UMLS 2011AA ObjectClass
    C1521840
    Number of Nontarget Lesions [in] Breast
    Description

    Non-TargetBreastLesionPresentCount

    Data type

    double

    Alias
    NCI Thesaurus ObjectClass
    C3824
    UMLS 2011AA ObjectClass
    C0221198
    NCI Thesaurus ObjectClass
    C25592
    UMLS 2011AA ObjectClass
    C1518389
    NCI Thesaurus ObjectClass
    C12971
    UMLS 2011AA ObjectClass
    C0006141
    NCI Thesaurus Property
    C25626
    UMLS 2011AA Property
    C0150312
    NCI Thesaurus ValueDomain
    C25463
    UMLS 2011AA ValueDomain
    C0750480
    Number of Nontarget Lesions [in] Axilla
    Description

    Non-TargetAxillaLesionPresentCount

    Data type

    double

    Alias
    NCI Thesaurus ObjectClass
    C3824
    UMLS 2011AA ObjectClass
    C0221198
    NCI Thesaurus ObjectClass
    C25592
    UMLS 2011AA ObjectClass
    C1518389
    NCI Thesaurus ObjectClass
    C12674
    UMLS 2011AA ObjectClass
    C0004454
    NCI Thesaurus Property
    C25626
    UMLS 2011AA Property
    C0150312
    NCI Thesaurus ValueDomain
    C25463
    UMLS 2011AA ValueDomain
    C0750480
    Lesion Number ([Target])
    Description

    LesionSiteNumber

    Data type

    double

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS 2011AA ValueDomain
    C0237753
    NCI Thesaurus ObjectClass
    C3824
    UMLS 2011AA ObjectClass
    C0221198
    NCI Thesaurus Property
    C25341
    UMLS 2011AA Property
    C0450429
    Target Lesion Site
    Description

    LesionTargetLocationType

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    NCI Thesaurus ObjectClass
    C3824
    UMLS 2011AA ObjectClass
    C0221198
    NCI Thesaurus Property
    C25341
    UMLS 2011AA Property
    C0450429
    NCI Thesaurus Property
    C25702
    UMLS 2011AA Property
    C1521840
    Longest Diameter of Lesion (s)
    Description

    LesionLongestDiameterMeasurement

    Data type

    double

    Measurement units
    • cm
    Alias
    NCI Thesaurus ObjectClass
    C3824
    UMLS 2011AA ObjectClass
    C0221198
    NCI Thesaurus Property
    C25285
    UMLS 2011AA Property
    C1301886
    NCI Thesaurus Property
    C25558
    UMLS 2011AA Property
    C1522425
    NCI Thesaurus ValueDomain
    C25209
    UMLS 2011AA ValueDomain
    C0242485
    NCI Thesaurus ValueDomain
    C25285
    UMLS 2011AA ValueDomain
    C1301886
    cm
    Sum of longest diameters of all target lesions (cm)
    Description

    LongestLesionSumDiameterMeasurement

    Data type

    double

    Alias
    NCI Thesaurus ObjectClass
    C25558
    UMLS 2011AA ObjectClass
    C1522425
    NCI Thesaurus ObjectClass
    C3824
    UMLS 2011AA ObjectClass
    C0221198
    NCI Thesaurus Property
    C25285
    UMLS 2011AA Property
    C1301886
    NCI Thesaurus Property
    C25697
    UMLS 2011AA Property
    C1515051
    NCI Thesaurus ValueDomain
    C25209
    UMLS 2011AA ValueDomain
    C0242485
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    Submit every 6 months from date of randomization for the first 5 years; yearly thereafter, and when a protocol event occurs. Fax Form F to 412-622-2111

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Unnamed1
    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)
    PatientNationalSurgicalAdjuvantBreastProjectIdentifierNumber
    Item
    NSABP Patient ID
    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)
    C15818 (NCI Thesaurus Property)
    C1513905 (UMLS 2011AA Property)
    Item Group
    Unnamed2
    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)
    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)
    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)
    ResponsiblePersonLastName
    Item
    Person Completing Form, Last Name
    text
    C25190 (NCI Thesaurus ObjectClass)
    C0027361 (UMLS 2011AA ObjectClass)
    C25657 (NCI Thesaurus ObjectClass)
    C1273518 (UMLS 2011AA ObjectClass)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    C25551 (NCI Thesaurus Property)
    C1517741 (UMLS 2011AA Property)
    C25191 (NCI Thesaurus ValueDomain)
    C1547383 (UMLS 2011AA ValueDomain)
    ResponsiblePersonFirstName
    Item
    Person Completing Form, First Name
    text
    C25190 (NCI Thesaurus ObjectClass)
    C0027361 (UMLS 2011AA ObjectClass)
    C25657 (NCI Thesaurus ObjectClass)
    C1273518 (UMLS 2011AA ObjectClass)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    C25509 (NCI Thesaurus Property)
    C1279901 (UMLS 2011AA Property)
    C25191 (NCI Thesaurus ValueDomain)
    C1547383 (UMLS 2011AA ValueDomain)
    ResponsiblePersonPhoneNumber
    Item
    Person Completing Form, Phone
    text
    C25337 (NCI Thesaurus ValueDomain)
    C0237753 (UMLS 2011AA ValueDomain)
    C25190 (NCI Thesaurus ObjectClass)
    C0027361 (UMLS 2011AA ObjectClass)
    C25657 (NCI Thesaurus ObjectClass)
    C1273518 (UMLS 2011AA ObjectClass)
    C25395 (NCI Thesaurus Property)
    C0039457 (UMLS 2011AA Property)
    ResponsiblePersonFaxNumber
    Item
    Person Completing Form, Fax
    text
    C25337 (NCI Thesaurus ValueDomain)
    C0237753 (UMLS 2011AA ValueDomain)
    C25190 (NCI Thesaurus ObjectClass)
    C0027361 (UMLS 2011AA ObjectClass)
    C25657 (NCI Thesaurus ObjectClass)
    C1273518 (UMLS 2011AA ObjectClass)
    C25210 (NCI Thesaurus Property)
    C0085205 (UMLS 2011AA Property)
    Item Group
    Unnamed3
    PatientBirthDate
    Item
    Patient's Date of Birth
    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 (USA only)
    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)
    Item Group
    Person Completing Form, Last Name
    Item
    Race (more than one may be marked)
    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.1
    Code List
    Race (more than one may be marked)
    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
    Method of Payment (mark primary method only)
    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.2
    Code List
    Method of Payment (mark primary method only)
    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
    Other (Other)
    C17649 (NCI Thesaurus)
    C0205394 (UMLS 2011AA)
    CL Item
    Military Or Veterans Sponsored Nos (Military or Veterans Sponsored, Not Otherwise Specified (NOS))
    CL Item
    Military Sponsored (including Champus & Tricare) (Military Sponsored (including CHAMPUS & TRICARE))
    CL Item
    Veterans Sponsored (Veterans Sponsored)
    CL Item
    Self Pay (no Insurance) (Self Pay (No Insurance))
    CL Item
    No Means Of Payment (no Insurance) (No means of payment (no insurance))
    CL Item
    Unknown (Unknown)
    C17998 (NCI Thesaurus)
    C0439673 (UMLS 2011AA)
    Item
    Ethnicity
    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
    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
    Country of Residence (if not 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)
    CL.4
    Code List
    Country of Residence (if not USA)
    CL Item
    Usa (US)
    CL Item
    Puerto Rico (PR)
    C17043 (NCI Thesaurus)
    C0034044 (UMLS 2011AA)
    CL Item
    Canada (CA)
    C16380 (NCI Thesaurus)
    C0006823 (UMLS 2011AA)
    CL Item
    Other (Other)
    PatientAddressCountryName
    Item
    Country of Residence
    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)
    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)
    Item Group
    How Did The Patient Answer The Following Questions On The Consent Form
    Item
    I agree to have blood samples collected three times during this study (These samples will be sent to the NSABP.)
    text
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    C12434 (NCI Thesaurus ObjectClass)
    C0229664 (UMLS 2011AA ObjectClass)
    C19157 (NCI Thesaurus ObjectClass)
    C0370003 (UMLS 2011AA ObjectClass)
    C25452 (NCI Thesaurus Property)
    CL.5
    Code List
    I agree to have blood samples collected three times during this study (These samples will be sent to the NSABP.)
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    Item
    My study doctor (or somone he or she shooses) may contact me in the future to ask me to take part in more research. (My study doctor or someone he or she chooses may contact me in the future to ask me to take part in more research.)
    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)
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    CL.6
    Code List
    My study doctor (or somone he or she shooses) may contact me in the future to ask me to take part in more research. (My study doctor or someone he or she chooses may contact me in the future to ask me to take part in more research.)
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    Item Group
    Unnamed5
    PatientHeightMeasurement
    Item
    Patient 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
    Patient 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)
    Item Group
    Stratification Factors
    Item
    Lymph Node Involvement
    text
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    C12745 (NCI Thesaurus ObjectClass)
    C0024204 (UMLS 2011AA ObjectClass)
    C25547 (NCI Thesaurus Property)
    CL.7
    Code List
    Lymph Node Involvement
    CL Item
    Negative Based On Clinical Evaluation (clinically negative)
    CL Item
    Positive Based On Clinical Evaluation (clinically positive)
    Item
    Receptor Status
    text
    C12971 (NCI Thesaurus ObjectClass)
    C0006141 (UMLS 2011AA ObjectClass)
    C17220 (NCI Thesaurus ObjectClass)
    C0041365 (UMLS 2011AA ObjectClass)
    C28154 (NCI Thesaurus ObjectClass)
    C0019929 (UMLS 2011AA ObjectClass)
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    C15220 (NCI Thesaurus Property)
    C0011900 (UMLS 2011AA Property)
    C25508 (NCI Thesaurus Property)
    C0205088 (UMLS 2011AA Property)
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    CL.8
    Code List
    Receptor Status
    CL Item
    Er And Pgr Negative (ER and PgR negative)
    CL Item
    Er And/or Pgr Positive (ER and/or PgR positive)
    PatientAgeYearCount
    Item
    Age
    double
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C29848 (NCI Thesaurus ValueDomain)
    C0439234 (UMLS 2011AA ValueDomain)
    C25463 (NCI Thesaurus ValueDomain)
    C0750480 (UMLS 2011AA ValueDomain)
    C25150 (NCI Thesaurus Property)
    C0001779 (UMLS 2011AA Property)
    Item Group
    Unnamed4
    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.9
    Code List
    In the opinion of the investigator, is the patient eligible?
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    Item
    Has the patient authorized the release of Protected Health Information to the NSABP?
    text
    C25180 (NCI Thesaurus ValueDomain)
    C1522602 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25460 (NCI Thesaurus Property)
    C1511481 (UMLS 2011AA Property)
    CL.10
    Code List
    Has the patient authorized the release of Protected Health Information to the NSABP?
    CL Item
    Yes: C49488 (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    CL Item
    No: C49487 (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    Item Group
    Diagnostic Core Needle Biopsy
    SurgicalProcedureCoreBiopsyPerformedDate
    Item
    Date of procedure (Date of procedure)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C15680 (NCI Thesaurus Property)
    C1318309 (UMLS 2011AA Property)
    C38000 (NCI Thesaurus Property)
    C0884358 (UMLS 2011AA Property)
    C15329 (NCI Thesaurus ObjectClass)
    C0543467 (UMLS 2011AA ObjectClass)
    ProfessionalOrganizationSurgicalPathologyIdentifierNumber
    Item
    Institutional surgical pathology number (core needle biopsy)
    text
    C19711 (NCI Thesaurus ObjectClass)
    C1522486 (UMLS 2011AA ObjectClass)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    C25698 (NCI Thesaurus Property)
    C18189 (NCI Thesaurus Property)
    C0030664 (UMLS 2011AA Property)
    C25337 (NCI Thesaurus ValueDomain)
    C0237753 (UMLS 2011AA ValueDomain)
    Item Group
    Core Biopsy Specimens For B-40 Correlative Studies
    SpecimenCollectedDate
    Item
    Date Specimen collected
    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)
    C2745955 (UMLS 2011AA Property)
    AgentIdentifierPTINumber
    Item
    PTI Control Number
    text
    C25337 (NCI Thesaurus ValueDomain)
    C0237753 (UMLS 2011AA ValueDomain)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    C1708 (NCI Thesaurus ObjectClass)
    C0450442 (UMLS 2011AA ObjectClass)
    AssessmentPerformedDate
    Item
    Date of Assessment
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C25367 (NCI Thesaurus ObjectClass)
    C25367 (NCI Thesaurus ValueDomain)
    C38000 (NCI Thesaurus Property)
    C0884358 (UMLS 2011AA Property)
    TargetLesionPresentCount
    Item
    Number of Target Lesions
    double
    C3824 (NCI Thesaurus ObjectClass)
    C0221198 (UMLS 2011AA ObjectClass)
    C25626 (NCI Thesaurus Property)
    C0150312 (UMLS 2011AA Property)
    C25463 (NCI Thesaurus ValueDomain)
    C0750480 (UMLS 2011AA ValueDomain)
    C25702 (NCI Thesaurus ObjectClass)
    C1521840 (UMLS 2011AA ObjectClass)
    Non-TargetBreastLesionPresentCount
    Item
    Number of Nontarget Lesions [in] Breast
    double
    C3824 (NCI Thesaurus ObjectClass)
    C0221198 (UMLS 2011AA ObjectClass)
    C25592 (NCI Thesaurus ObjectClass)
    C1518389 (UMLS 2011AA ObjectClass)
    C12971 (NCI Thesaurus ObjectClass)
    C0006141 (UMLS 2011AA ObjectClass)
    C25626 (NCI Thesaurus Property)
    C0150312 (UMLS 2011AA Property)
    C25463 (NCI Thesaurus ValueDomain)
    C0750480 (UMLS 2011AA ValueDomain)
    Non-TargetAxillaLesionPresentCount
    Item
    Number of Nontarget Lesions [in] Axilla
    double
    C3824 (NCI Thesaurus ObjectClass)
    C0221198 (UMLS 2011AA ObjectClass)
    C25592 (NCI Thesaurus ObjectClass)
    C1518389 (UMLS 2011AA ObjectClass)
    C12674 (NCI Thesaurus ObjectClass)
    C0004454 (UMLS 2011AA ObjectClass)
    C25626 (NCI Thesaurus Property)
    C0150312 (UMLS 2011AA Property)
    C25463 (NCI Thesaurus ValueDomain)
    C0750480 (UMLS 2011AA ValueDomain)
    LesionSiteNumber
    Item
    Lesion Number ([Target])
    double
    C25337 (NCI Thesaurus ValueDomain)
    C0237753 (UMLS 2011AA ValueDomain)
    C3824 (NCI Thesaurus ObjectClass)
    C0221198 (UMLS 2011AA ObjectClass)
    C25341 (NCI Thesaurus Property)
    C0450429 (UMLS 2011AA Property)
    Item
    Target Lesion Site
    text
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    C3824 (NCI Thesaurus ObjectClass)
    C0221198 (UMLS 2011AA ObjectClass)
    C25341 (NCI Thesaurus Property)
    C0450429 (UMLS 2011AA Property)
    C25702 (NCI Thesaurus Property)
    C1521840 (UMLS 2011AA Property)
    CL.11
    Code List
    Target Lesion Site
    CL Item
    Breast (Breast)
    C12971 (NCI Thesaurus)
    C0006141 (UMLS 2011AA)
    CL Item
    Axilla (Axilla)
    C12674 (NCI Thesaurus)
    C0004454 (UMLS 2011AA)
    LesionLongestDiameterMeasurement
    Item
    Longest Diameter of Lesion (s)
    double
    C3824 (NCI Thesaurus ObjectClass)
    C0221198 (UMLS 2011AA ObjectClass)
    C25285 (NCI Thesaurus Property)
    C1301886 (UMLS 2011AA Property)
    C25558 (NCI Thesaurus Property)
    C1522425 (UMLS 2011AA Property)
    C25209 (NCI Thesaurus ValueDomain)
    C0242485 (UMLS 2011AA ValueDomain)
    C25285 (NCI Thesaurus ValueDomain)
    C1301886 (UMLS 2011AA ValueDomain)
    LongestLesionSumDiameterMeasurement
    Item
    Sum of longest diameters of all target lesions (cm)
    double
    C25558 (NCI Thesaurus ObjectClass)
    C1522425 (UMLS 2011AA ObjectClass)
    C3824 (NCI Thesaurus ObjectClass)
    C0221198 (UMLS 2011AA ObjectClass)
    C25285 (NCI Thesaurus Property)
    C1301886 (UMLS 2011AA Property)
    C25697 (NCI Thesaurus Property)
    C1515051 (UMLS 2011AA Property)
    C25209 (NCI Thesaurus ValueDomain)
    C0242485 (UMLS 2011AA ValueDomain)
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