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ID

11337

Beschrijving

NSABP Protocol B-40 - Registration Form NCT00408408 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

Trefwoorden

Versies (4)
  1. 26-08-12 26-08-12 -
  2. 09-01-15 09-01-15 - Martin Dugas
  3. 03-07-15 03-07-15 -
  4. 04-08-15 04-08-15 - Martin Dugas
Geüploaded op

3 juli 2015

DOI

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Licentie

Creative Commons BY-NC 3.0 Legacy
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    NSABP Protocol B-40 - Registration Form NCT00408408

    Engels

    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 Formulieren  
    NSABP REGISTRATION FORM
    Beschrijving

    NSABP REGISTRATION FORM

    Patient Initials (Last First Middle)
    Beschrijving

    Patient Initials

    Datatype

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS CUI-1
    C2986440
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25536
    NSABP Patient ID
    Beschrijving

    Patient ID NSABP

    Datatype

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C2348585
    NCI Thesaurus ObjectClass
    C16960
    UMLS CUI-2
    C1513905
    NCI Thesaurus Property
    C25364
    NCI Thesaurus Property-2
    C15818
    Patient's Date of Birth
    Beschrijving

    Birth Date

    Datatype

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS CUI-1
    C0421451
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus ValueDomain-2
    C25367
    NCI Thesaurus Property
    C25155
    Patient Social Security Number (USA only)
    Beschrijving

    PatientPersonSocialSecurityNumber

    Datatype

    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
    Institution/Affiliate
    Beschrijving

    Institution Name

    Datatype

    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
    Beschrijving

    Investigator Name

    Datatype

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS CUI-1
    C2826892
    NCI Thesaurus Property
    C25364
    NCI Thesaurus ObjectClass
    C17089
    NCI Thesaurus ObjectClass-2
    C25644
    Date Informed Consent Signed
    Beschrijving

    InformedConsentFormSignedDate

    Datatype

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ValueDomain-2
    C25367
    NCI Thesaurus ObjectClass
    C16468
    UMLS 2011AA ObjectClass
    C0009797
    NCI Thesaurus Property
    C25679
    Person Completing Form, Last Name
    Beschrijving

    Person Completing Form Last Name

    Datatype

    text

    Alias
    NCI Thesaurus ObjectClass
    C25190
    UMLS CUI-1
    C1550483
    NCI Thesaurus ObjectClass-2
    C25657
    UMLS CUI-2
    C1301584
    NCI Thesaurus Property
    C25364
    NCI Thesaurus Property-2
    C25551
    NCI Thesaurus ValueDomain
    C25191
    Person Completing Form, First Name
    Beschrijving

    Person Completing Form First Name

    Datatype

    text

    Alias
    NCI Thesaurus ObjectClass
    C25190
    UMLS CUI-1
    C1550483
    NCI Thesaurus ObjectClass-2
    C25657
    UMLS CUI-2
    C1443235
    NCI Thesaurus Property
    C25364
    NCI Thesaurus Property-2
    C25509
    NCI Thesaurus ValueDomain
    C25191
    Person Completing Form, Phone
    Beschrijving

    Person Completing Form Phone

    Datatype

    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
    Person Completing Form, Fax
    Beschrijving

    ResponsiblePersonFaxNumber

    Datatype

    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
    Race (more than one may be marked)
    Beschrijving

    Racial Group

    Datatype

    text

    Alias
    NCI Thesaurus ValueDomain
    C25372
    UMLS CUI-1
    C0034510
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C17049
    Method of Payment (mark primary method only)
    Beschrijving

    PatientPaymentType

    Datatype

    text

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

    Ethnic Group

    Datatype

    text

    Alias
    NCI Thesaurus ValueDomain
    C25372
    UMLS CUI-1
    C0015031
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C16564
    Country of Residence (if not USA)
    Beschrijving

    PatientAddressCountryCode

    Datatype

    text

    Alias
    NCI Thesaurus ValueDomain
    C25162
    UMLS 2011AA ValueDomain
    C0805701
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C25407
    UMLS 2011AA Property
    C1442065
    Country of Residence
    Beschrijving

    Country of current residence

    Datatype

    text

    Alias
    NCI Thesaurus ObjectClass
    C16960
    UMLS CUI-1
    C3258975
    NCI Thesaurus ValueDomain
    C25464
    NCI Thesaurus Property
    C25407
    NCI Thesaurus ValueDomain-2
    C42614
    Patient Zip Code (USA)
    Beschrijving

    PatientAddressPostalCode

    Datatype

    text

    Alias
    NCI Thesaurus ValueDomain
    C25162
    UMLS 2011AA ValueDomain
    C0805701
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C25407
    UMLS 2011AA Property
    C1442065
    Patient Height (cm)
    Beschrijving

    Patient Height

    Datatype

    float

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

    Patient Weight

    Datatype

    float

    Maateenheden
    • Kg
    Alias
    NCI Thesaurus ValueDomain
    C25209
    UMLS CUI-1
    C0005910
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25208
    Kg
    How Did The Patient Answer The Following Questions On The Consent Form
    Beschrijving

    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.)
    Beschrijving

    BloodSpecimenCollectedInd-3

    Datatype

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    NCI Thesaurus ObjectClass
    C12434
    UMLS 2011AA ObjectClass
    C0229664
    NCI Thesaurus ObjectClass-2
    C19157
    UMLS 2011AA ObjectClass-2
    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.)
    Beschrijving

    PatientContactConsentInd-2

    Datatype

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C67527
    UMLS 2011AA Property
    C0016884
    NCI Thesaurus Property-2
    C25460
    UMLS 2011AA Property-2
    C1511481
    NCI Thesaurus Property-3
    C16452
    UMLS 2011AA Property-3
    C0009452
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    Stratification Factors
    Beschrijving

    Stratification Factors

    Lymph Node Involvement
    Beschrijving

    LymphNodeInvolvementType

    Datatype

    text

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

    BreastHormoneReceptorTumorMarkerFinalDiagnosisResultType

    Datatype

    text

    Alias
    NCI Thesaurus ObjectClass
    C12971
    UMLS 2011AA ObjectClass
    C0006141
    NCI Thesaurus ObjectClass-2
    C17220
    UMLS 2011AA ObjectClass-2
    C0041365
    NCI Thesaurus ObjectClass-3
    C28154
    UMLS 2011AA ObjectClass-3
    C0019929
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    NCI Thesaurus Property-2
    C15220
    UMLS 2011AA Property-2
    C0011900
    NCI Thesaurus Property-3
    C25508
    UMLS 2011AA Property-3
    C0205088
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    Age
    Beschrijving

    PatientAgeYearCount

    Datatype

    float

    Alias
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus ValueDomain
    C29848
    UMLS 2011AA ValueDomain
    C0439234
    NCI Thesaurus ValueDomain-2
    C25463
    UMLS 2011AA ValueDomain-2
    C0750480
    NCI Thesaurus Property
    C25150
    UMLS 2011AA Property
    C0001779
    Certification of Eligibility
    Beschrijving

    Certification of Eligibility

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

    Eligibility for trial

    Datatype

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS CUI-1
    C1302261
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25171
    Has the patient authorized the release of Protected Health Information to the NSABP?
    Beschrijving

    PatientPHIConsentIndicator

    Datatype

    boolean

    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
    Beschrijving

    Diagnostic Core Needle Biopsy

    Date of procedure (Date of procedure)
    Beschrijving

    SurgicalProcedureCoreBiopsyPerformedDate

    Datatype

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus Property
    C15680
    UMLS 2011AA Property
    C1318309
    NCI Thesaurus Property-2
    C38000
    UMLS 2011AA Property-2
    C0884358
    NCI Thesaurus ObjectClass
    C15329
    UMLS 2011AA ObjectClass
    C0543467
    Institutional surgical pathology number (core needle biopsy)
    Beschrijving

    ProfessionalOrganizationSurgicalPathologyIdentifierNumber

    Datatype

    text

    Alias
    NCI Thesaurus ObjectClass
    C19711
    UMLS 2011AA ObjectClass
    C1522486
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    NCI Thesaurus Property-2
    C25698
    NCI Thesaurus Property-3
    C18189
    UMLS 2011AA Property-2
    C0030664
    NCI Thesaurus ValueDomain
    C25337
    UMLS 2011AA ValueDomain
    C0237753
    Biopsy Specimens For B-40 Correlative Studies
    Beschrijving

    Biopsy Specimens For B-40 Correlative Studies

    Date Specimen collected
    Beschrijving

    SpecimenCollectedDate

    Datatype

    date

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

    AgentIdentifierPTINumber

    Datatype

    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
    Beschrijving

    Target Lesions

    Date of Assessment
    Beschrijving

    Assessment Date

    Datatype

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS CUI-1
    C2985720
    NCI Thesaurus ObjectClass
    C25367
    NCI Thesaurus ValueDomain-2
    C25367
    NCI Thesaurus Property
    C38000
    Number of Target Lesions
    Beschrijving

    TargetLesionPresentCount

    Datatype

    float

    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-2
    C25702
    UMLS 2011AA ObjectClass-2
    C1521840
    Number of Nontarget Lesions [in] Breast
    Beschrijving

    Non-TargetBreastLesionPresentCount

    Datatype

    float

    Alias
    NCI Thesaurus ObjectClass
    C3824
    UMLS 2011AA ObjectClass
    C0221198
    NCI Thesaurus ObjectClass-2
    C25592
    UMLS 2011AA ObjectClass-2
    C1518389
    NCI Thesaurus ObjectClass-3
    C12971
    UMLS 2011AA ObjectClass-3
    C0006141
    NCI Thesaurus Property
    C25626
    UMLS 2011AA Property
    C0150312
    NCI Thesaurus ValueDomain
    C25463
    UMLS 2011AA ValueDomain
    C0750480
    Number of Nontarget Lesions [in] Axilla
    Beschrijving

    Non-TargetAxillaLesionPresentCount

    Datatype

    float

    Alias
    NCI Thesaurus ObjectClass
    C3824
    UMLS 2011AA ObjectClass
    C0221198
    NCI Thesaurus ObjectClass-2
    C25592
    UMLS 2011AA ObjectClass-2
    C1518389
    NCI Thesaurus ObjectClass-3
    C12674
    UMLS 2011AA ObjectClass-3
    C0004454
    NCI Thesaurus Property
    C25626
    UMLS 2011AA Property
    C0150312
    NCI Thesaurus ValueDomain
    C25463
    UMLS 2011AA ValueDomain
    C0750480
    Lesion Number ([Target])
    Beschrijving

    LesionSiteNumber

    Datatype

    float

    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
    Beschrijving

    LesionTargetLocationType

    Datatype

    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-2
    C25702
    UMLS 2011AA Property-2
    C1521840
    Longest Diameter of Lesion (s)
    Beschrijving

    Longest Diameter of Lesion

    Datatype

    float

    Maateenheden
    • cm
    Alias
    NCI Thesaurus ObjectClass
    C3824
    UMLS CUI-1
    C0221198
    NCI Thesaurus Property
    C25285
    UMLS CUI-2
    C1301886
    NCI Thesaurus Property-2
    C25558
    UMLS CUI-3
    C1522425
    NCI Thesaurus ValueDomain
    C25209
    NCI Thesaurus ValueDomain-2
    C25285
    cm
    Sum of longest diameters of all target lesions (cm)
    Beschrijving

    LongestLesionSumDiameterMeasurement

    Datatype

    float

    Alias
    NCI Thesaurus ObjectClass
    C25558
    UMLS 2011AA ObjectClass
    C1522425
    NCI Thesaurus ObjectClass-2
    C3824
    UMLS 2011AA ObjectClass-2
    C0221198
    NCI Thesaurus Property
    C25285
    UMLS 2011AA Property
    C1301886
    NCI Thesaurus Property-2
    C25697
    UMLS 2011AA Property-2
    C1515051
    NCI Thesaurus ValueDomain
    C25209
    UMLS 2011AA ValueDomain
    C0242485
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    Similar models

    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 Formulieren
    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    Alias
    Item Group
    NSABP REGISTRATION FORM
    Patient Initials
    Item
    Patient Initials (Last First Middle)
    text
    C25191 (NCI Thesaurus ValueDomain)
    C2986440 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C25536 (NCI Thesaurus Property)
    Patient ID NSABP
    Item
    NSABP Patient ID
    text
    C25337 (NCI Thesaurus ValueDomain)
    C2348585 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C1513905 (UMLS CUI-2)
    C25364 (NCI Thesaurus Property)
    C15818 (NCI Thesaurus Property-2)
    Birth Date
    Item
    Patient's Date of Birth
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0421451 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C25367 (NCI Thesaurus ValueDomain-2)
    C25155 (NCI Thesaurus Property)
    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)
    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)
    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)
    Person Completing Form Last Name
    Item
    Person Completing Form, Last Name
    text
    C25190 (NCI Thesaurus ObjectClass)
    C1550483 (UMLS CUI-1)
    C25657 (NCI Thesaurus ObjectClass-2)
    C1301584 (UMLS CUI-2)
    C25364 (NCI Thesaurus Property)
    C25551 (NCI Thesaurus Property-2)
    C25191 (NCI Thesaurus ValueDomain)
    Person Completing Form First Name
    Item
    Person Completing Form, First Name
    text
    C25190 (NCI Thesaurus ObjectClass)
    C1550483 (UMLS CUI-1)
    C25657 (NCI Thesaurus ObjectClass-2)
    C1443235 (UMLS CUI-2)
    C25364 (NCI Thesaurus Property)
    C25509 (NCI Thesaurus Property-2)
    C25191 (NCI Thesaurus ValueDomain)
    Person Completing Form Phone
    Item
    Person Completing Form, 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
    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-2)
    C1273518 (UMLS 2011AA ObjectClass-2)
    C25210 (NCI Thesaurus Property)
    C0085205 (UMLS 2011AA Property)
    Item
    Race (more than one may be marked)
    text
    C25372 (NCI Thesaurus ValueDomain)
    C0034510 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C17049 (NCI Thesaurus 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)
    C0015031 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C16564 (NCI Thesaurus 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)
    Country of current residence
    Item
    Country of Residence
    text
    C16960 (NCI Thesaurus ObjectClass)
    C3258975 (UMLS CUI-1)
    C25464 (NCI Thesaurus ValueDomain)
    C25407 (NCI Thesaurus Property)
    C42614 (NCI Thesaurus ValueDomain-2)
    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)
    Patient Height
    Item
    Patient Height (cm)
    float
    C25209 (NCI Thesaurus ValueDomain)
    C0489786 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C25347 (NCI Thesaurus Property)
    Patient Weight
    Item
    Patient Weight (kg)
    float
    C25209 (NCI Thesaurus ValueDomain)
    C0005910 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C25208 (NCI Thesaurus Property)
    Item Group
    How Did The Patient Answer The Following Questions On The Consent Form
    BloodSpecimenCollectedInd-3
    Item
    I agree to have blood samples collected three times during this study (These samples will be sent to the NSABP.)
    boolean
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    C12434 (NCI Thesaurus ObjectClass)
    C0229664 (UMLS 2011AA ObjectClass)
    C19157 (NCI Thesaurus ObjectClass-2)
    C0370003 (UMLS 2011AA ObjectClass-2)
    C25452 (NCI Thesaurus Property)
    PatientContactConsentInd-2
    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.)
    boolean
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C67527 (NCI Thesaurus Property)
    C0016884 (UMLS 2011AA Property)
    C25460 (NCI Thesaurus Property-2)
    C1511481 (UMLS 2011AA Property-2)
    C16452 (NCI Thesaurus Property-3)
    C0009452 (UMLS 2011AA Property-3)
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    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-2)
    C0041365 (UMLS 2011AA ObjectClass-2)
    C28154 (NCI Thesaurus ObjectClass-3)
    C0019929 (UMLS 2011AA ObjectClass-3)
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    C15220 (NCI Thesaurus Property-2)
    C0011900 (UMLS 2011AA Property-2)
    C25508 (NCI Thesaurus Property-3)
    C0205088 (UMLS 2011AA Property-3)
    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
    float
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C29848 (NCI Thesaurus ValueDomain)
    C0439234 (UMLS 2011AA ValueDomain)
    C25463 (NCI Thesaurus ValueDomain-2)
    C0750480 (UMLS 2011AA ValueDomain-2)
    C25150 (NCI Thesaurus Property)
    C0001779 (UMLS 2011AA Property)
    Item Group
    Certification of Eligibility
    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)
    PatientPHIConsentIndicator
    Item
    Has the patient authorized the release of Protected Health Information to the NSABP?
    boolean
    C25180 (NCI Thesaurus ValueDomain)
    C1522602 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25460 (NCI Thesaurus Property)
    C1511481 (UMLS 2011AA Property)
    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-2)
    C0884358 (UMLS 2011AA Property-2)
    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-2)
    C18189 (NCI Thesaurus Property-3)
    C0030664 (UMLS 2011AA Property-2)
    C25337 (NCI Thesaurus ValueDomain)
    C0237753 (UMLS 2011AA ValueDomain)
    Item Group
    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-2)
    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)
    Assessment Date
    Item
    Date of Assessment
    date
    C25164 (NCI Thesaurus ValueDomain)
    C2985720 (UMLS CUI-1)
    C25367 (NCI Thesaurus ObjectClass)
    C25367 (NCI Thesaurus ValueDomain-2)
    C38000 (NCI Thesaurus Property)
    TargetLesionPresentCount
    Item
    Number of Target Lesions
    float
    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-2)
    C1521840 (UMLS 2011AA ObjectClass-2)
    Non-TargetBreastLesionPresentCount
    Item
    Number of Nontarget Lesions [in] Breast
    float
    C3824 (NCI Thesaurus ObjectClass)
    C0221198 (UMLS 2011AA ObjectClass)
    C25592 (NCI Thesaurus ObjectClass-2)
    C1518389 (UMLS 2011AA ObjectClass-2)
    C12971 (NCI Thesaurus ObjectClass-3)
    C0006141 (UMLS 2011AA ObjectClass-3)
    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
    float
    C3824 (NCI Thesaurus ObjectClass)
    C0221198 (UMLS 2011AA ObjectClass)
    C25592 (NCI Thesaurus ObjectClass-2)
    C1518389 (UMLS 2011AA ObjectClass-2)
    C12674 (NCI Thesaurus ObjectClass-3)
    C0004454 (UMLS 2011AA ObjectClass-3)
    C25626 (NCI Thesaurus Property)
    C0150312 (UMLS 2011AA Property)
    C25463 (NCI Thesaurus ValueDomain)
    C0750480 (UMLS 2011AA ValueDomain)
    LesionSiteNumber
    Item
    Lesion Number ([Target])
    float
    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-2)
    C1521840 (UMLS 2011AA Property-2)
    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)
    Longest Diameter of Lesion
    Item
    Longest Diameter of Lesion (s)
    float
    C3824 (NCI Thesaurus ObjectClass)
    C0221198 (UMLS CUI-1)
    C25285 (NCI Thesaurus Property)
    C1301886 (UMLS CUI-2)
    C25558 (NCI Thesaurus Property-2)
    C1522425 (UMLS CUI-3)
    C25209 (NCI Thesaurus ValueDomain)
    C25285 (NCI Thesaurus ValueDomain-2)
    LongestLesionSumDiameterMeasurement
    Item
    Sum of longest diameters of all target lesions (cm)
    float
    C25558 (NCI Thesaurus ObjectClass)
    C1522425 (UMLS 2011AA ObjectClass)
    C3824 (NCI Thesaurus ObjectClass-2)
    C0221198 (UMLS 2011AA ObjectClass-2)
    C25285 (NCI Thesaurus Property)
    C1301886 (UMLS 2011AA Property)
    C25697 (NCI Thesaurus Property-2)
    C1515051 (UMLS 2011AA Property-2)
    C25209 (NCI Thesaurus ValueDomain)
    C0242485 (UMLS 2011AA ValueDomain)
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