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1190

Description

S1007 Prestudy Form - Randomized Study (6230) Tamoxifen Citrate, Letrozole, Anastrozole, or Exemestane With or Without Chemotherapy in Treating Patients With Invasive RxPONDER Breast Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=90DE259F-A7AB-E9EB-E040-BB89AD436D98

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=90DE259F-A7AB-E9EB-E040-BB89AD436D98

Keywords

Versions (2)
  1. 8/27/12 8/27/12 -
  2. 1/9/15 1/9/15 - Martin Dugas
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August 27, 2012

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Creative Commons BY-NC 3.0 Legacy
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    Breast Cancer NCT01272037 Pre-Study - S1007 Prestudy Form - Randomized Study (6230) - 3141162v1.0

    English

    Instructions: Submit this form within 7 days of registration. All dates are MONTH, DAY, YEAR. Explain any blank fields or blank dates in the Comments section. Place an X in appropriate boxes. Circle AMENDED items in red and write AMENDED across top of form

    1 forms  
    Unnamed1
    Description

    Unnamed1

    SWOG Patient ID
    Description

    PatientSouthwestOncologyGroupIdentifierNumber

    Data type

    double

    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
    C25699
    UMLS 2011AA Property
    C1519429
    SWOG Study No.
    Description

    ProtocolSWOGIdentifierNumber

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS 2011AA ValueDomain
    C0237753
    NCI Thesaurus ObjectClass
    C25320
    UMLS 2011AA ObjectClass
    C1507394
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    NCI Thesaurus Property
    C25699
    UMLS 2011AA Property
    C1519429
    Registration Step
    Description

    RegistrationStepNumber

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS 2011AA ValueDomain
    C0237753
    NCI Thesaurus ObjectClass
    C25646
    UMLS 2011AA ObjectClass
    C1514821
    NCI Thesaurus Property
    C16154
    UMLS 2011AA Property
    C1704379
    NCI Thesaurus ValueDomain
    C16154
    UMLS 2011AA ValueDomain
    C1704379
    Patient Initials (L, F M)
    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
    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
    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
    Participating Group Name
    Description

    ParticipatingGroupName

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS 2011AA ValueDomain
    C1547383
    NCI Thesaurus ObjectClass
    C25608
    UMLS 2011AA ObjectClass
    C0679823
    NCI Thesaurus ObjectClass
    C17005
    UMLS 2011AA ObjectClass
    C1257890
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    Participating Group Study No.
    Description

    ProtocolParticipatingIdentifierNumber

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS 2011AA ValueDomain
    C0237753
    NCI Thesaurus ObjectClass
    C25320
    UMLS 2011AA ObjectClass
    C1507394
    NCI Thesaurus Property
    C25608
    UMLS 2011AA Property
    C0679823
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    Participating Group Patient ID
    Description

    PatientParticipatingIdentifierNumber

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS 2011AA ValueDomain
    C0237753
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C25608
    UMLS 2011AA Property
    C0679823
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    Patient And Disease Description
    Description

    Patient And Disease Description

    Oncotype DX Recurrence Score
    Description

    LaboratoryProcedureOncotypeDXBreastCancerAssayResultScore

    Data type

    double

    Alias
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus Property
    C52159
    UMLS 2011AA Property
    C1709318
    NCI Thesaurus ValueDomain
    C25338
    UMLS 2011AA ValueDomain
    C0449820
    Oncotype DX ER Score
    Description

    LaboratoryProcedureOncotypeDXBreastCancerAssayEstrogenReceptorStatusResultScore

    Data type

    double

    Alias
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    NCI Thesaurus Property
    C52159
    UMLS 2011AA Property
    C1709318
    NCI Thesaurus Property
    C16150
    UMLS 2011AA Property
    C1516974
    NCI Thesaurus ValueDomain
    C25338
    UMLS 2011AA ValueDomain
    C0449820
    Oncotype DX PR Score
    Description

    LaboratoryProcedureOncotypeDXBreastCancerAssayProgesteroneReceptorStatusResultScore

    Data type

    double

    Alias
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    NCI Thesaurus Property
    C52159
    UMLS 2011AA Property
    C1709318
    NCI Thesaurus Property
    C16149
    UMLS 2011AA Property
    C1514471
    NCI Thesaurus ValueDomain
    C25338
    UMLS 2011AA ValueDomain
    C0449820
    Oncotype DX HER2 Score
    Description

    LaboratoryProcedureOncotypeDXBreastCancerAssayHER2ResultScore

    Data type

    double

    Alias
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    NCI Thesaurus Property
    C17756
    UMLS 2011AA Property
    C0242957
    NCI Thesaurus Property
    C52159
    UMLS 2011AA Property
    C1709318
    NCI Thesaurus ValueDomain
    C25338
    UMLS 2011AA ValueDomain
    C0449820
    Requisition Number
    Description

    PatientOncotypeDXBreastCancerAssayIdentifierNumber

    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
    C52159
    UMLS 2011AA Property
    C1709318
    Date of Oncotype DX Score Report (MM DD YYYY)
    Description

    LaboratoryProcedureOncotypeDXBreastCancerAssayResultDate

    Data type

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus Property
    C52159
    UMLS 2011AA Property
    C1709318
    Has the patient suggested or indicated that she will not follow the randomized treatment assignment
    Description

    PatientNoRandomizationInd-2

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C49487
    UMLS 2011AA Property
    C1298908
    NCI Thesaurus Property
    C25196
    UMLS 2011AA Property
    C0034656
    Indicate Reason (If yes)
    Description

    PatientNoRandomizationReason

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25638
    UMLS 2011AA ValueDomain
    C0392360
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C49487
    UMLS 2011AA Property
    C1298908
    NCI Thesaurus Property
    C25196
    UMLS 2011AA Property
    C0034656
    Comments
    Description

    Comments

    Comments
    Description

    ResearchCommentsText

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25704
    UMLS 2011AA ValueDomain
    C1527021
    NCI Thesaurus ObjectClass
    C15319
    NCI Thesaurus Property
    C25393
    UMLS 2011AA Property
    C0282411
    Back to the top of the page

    Similar models

    Instructions: Submit this form within 7 days of registration. All dates are MONTH, DAY, YEAR. Explain any blank fields or blank dates in the Comments section. Place an X in appropriate boxes. Circle AMENDED items in red and write AMENDED across top of form

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Unnamed1
    PatientSouthwestOncologyGroupIdentifierNumber
    Item
    SWOG Patient ID
    double
    C25337 (NCI Thesaurus ValueDomain)
    C0237753 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    C25699 (NCI Thesaurus Property)
    C1519429 (UMLS 2011AA Property)
    ProtocolSWOGIdentifierNumber
    Item
    SWOG Study No.
    text
    C25337 (NCI Thesaurus ValueDomain)
    C0237753 (UMLS 2011AA ValueDomain)
    C25320 (NCI Thesaurus ObjectClass)
    C1507394 (UMLS 2011AA ObjectClass)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    C25699 (NCI Thesaurus Property)
    C1519429 (UMLS 2011AA Property)
    RegistrationStepNumber
    Item
    Registration Step
    text
    C25337 (NCI Thesaurus ValueDomain)
    C0237753 (UMLS 2011AA ValueDomain)
    C25646 (NCI Thesaurus ObjectClass)
    C1514821 (UMLS 2011AA ObjectClass)
    C16154 (NCI Thesaurus Property)
    C1704379 (UMLS 2011AA Property)
    C16154 (NCI Thesaurus ValueDomain)
    C1704379 (UMLS 2011AA ValueDomain)
    PatientInitialsName
    Item
    Patient Initials (L, F M)
    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)
    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
    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)
    ParticipatingGroupName
    Item
    Participating Group Name
    text
    C25191 (NCI Thesaurus ValueDomain)
    C1547383 (UMLS 2011AA ValueDomain)
    C25608 (NCI Thesaurus ObjectClass)
    C0679823 (UMLS 2011AA ObjectClass)
    C17005 (NCI Thesaurus ObjectClass)
    C1257890 (UMLS 2011AA ObjectClass)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    ProtocolParticipatingIdentifierNumber
    Item
    Participating Group Study No.
    text
    C25337 (NCI Thesaurus ValueDomain)
    C0237753 (UMLS 2011AA ValueDomain)
    C25320 (NCI Thesaurus ObjectClass)
    C1507394 (UMLS 2011AA ObjectClass)
    C25608 (NCI Thesaurus Property)
    C0679823 (UMLS 2011AA Property)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    PatientParticipatingIdentifierNumber
    Item
    Participating Group Patient ID
    text
    C25337 (NCI Thesaurus ValueDomain)
    C0237753 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25608 (NCI Thesaurus Property)
    C0679823 (UMLS 2011AA Property)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    Item Group
    Patient And Disease Description
    LaboratoryProcedureOncotypeDXBreastCancerAssayResultScore
    Item
    Oncotype DX Recurrence Score
    double
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C52159 (NCI Thesaurus Property)
    C1709318 (UMLS 2011AA Property)
    C25338 (NCI Thesaurus ValueDomain)
    C0449820 (UMLS 2011AA ValueDomain)
    LaboratoryProcedureOncotypeDXBreastCancerAssayEstrogenReceptorStatusResultScore
    Item
    Oncotype DX ER Score
    double
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    C52159 (NCI Thesaurus Property)
    C1709318 (UMLS 2011AA Property)
    C16150 (NCI Thesaurus Property)
    C1516974 (UMLS 2011AA Property)
    C25338 (NCI Thesaurus ValueDomain)
    C0449820 (UMLS 2011AA ValueDomain)
    LaboratoryProcedureOncotypeDXBreastCancerAssayProgesteroneReceptorStatusResultScore
    Item
    Oncotype DX PR Score
    double
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    C52159 (NCI Thesaurus Property)
    C1709318 (UMLS 2011AA Property)
    C16149 (NCI Thesaurus Property)
    C1514471 (UMLS 2011AA Property)
    C25338 (NCI Thesaurus ValueDomain)
    C0449820 (UMLS 2011AA ValueDomain)
    LaboratoryProcedureOncotypeDXBreastCancerAssayHER2ResultScore
    Item
    Oncotype DX HER2 Score
    double
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    C17756 (NCI Thesaurus Property)
    C0242957 (UMLS 2011AA Property)
    C52159 (NCI Thesaurus Property)
    C1709318 (UMLS 2011AA Property)
    C25338 (NCI Thesaurus ValueDomain)
    C0449820 (UMLS 2011AA ValueDomain)
    PatientOncotypeDXBreastCancerAssayIdentifierNumber
    Item
    Requisition Number
    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)
    C52159 (NCI Thesaurus Property)
    C1709318 (UMLS 2011AA Property)
    LaboratoryProcedureOncotypeDXBreastCancerAssayResultDate
    Item
    Date of Oncotype DX Score Report (MM DD YYYY)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C52159 (NCI Thesaurus Property)
    C1709318 (UMLS 2011AA Property)
    Item
    Has the patient suggested or indicated that she will not follow the randomized treatment assignment
    text
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C49487 (NCI Thesaurus Property)
    C1298908 (UMLS 2011AA Property)
    C25196 (NCI Thesaurus Property)
    C0034656 (UMLS 2011AA Property)
    CL.1
    Code List
    Has the patient suggested or indicated that she will not follow the randomized treatment assignment
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    Item
    Indicate Reason (If yes)
    text
    C25638 (NCI Thesaurus ValueDomain)
    C0392360 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C49487 (NCI Thesaurus Property)
    C1298908 (UMLS 2011AA Property)
    C25196 (NCI Thesaurus Property)
    C0034656 (UMLS 2011AA Property)
    CL.2
    Code List
    Indicate Reason (If yes)
    CL Item
    Assigned To Chemotherapy But Does Not Want To Receive Chemotherapy (Assigned to chemotherapy but does not want to receive chemotherapy)
    CL Item
    Assigned To No Chemotherapy But Wants To Receive Chemotherapy (Assigned to no chemotherapy but wants to receive chemotherapy)
    Item Group
    Comments
    ResearchCommentsText
    Item
    Comments
    text
    C25704 (NCI Thesaurus ValueDomain)
    C1527021 (UMLS 2011AA ValueDomain)
    C15319 (NCI Thesaurus ObjectClass)
    C25393 (NCI Thesaurus Property)
    C0282411 (UMLS 2011AA Property)
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