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ID

6803

Descrizione

Phase II Breast Cancer - Summary Response/Progression Form for Solid Tumors Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=25794336-1BEF-04E8-E044-0003BA3F9857

collegamento

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=25794336-1BEF-04E8-E044-0003BA3F9857

Keywords

versioni (2)
  1. 19/09/12 19/09/12 -
  2. 08/01/15 08/01/15 - Martin Dugas
Caricato su

8 gennaio 2015

DOI

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Licenza

Creative Commons BY-NC 3.0 Legacy
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    Response - Phase II Breast Cancer - Summary Response/Progression Form for Solid Tumors - 2582834v1.0

    Inglese

    [Optional Form ? May be selected by specific disease committees where appropriate.]

    1 moduli  
    1. StudyEvent: Phase II Breast Cancer - Summary Response/Progression Form for Solid Tumors
      1. [Optional Form ? May be selected by specific disease committees where appropriate.]
    Crf Header
    Descrizione

    Crf Header

    Coordinating Group Protocol No.
    Descrizione

    Protocol ID Coordinating Group

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C3274381
    NCI Thesaurus ObjectClass
    C25320
    UMLS CUI-2
    C1711341
    NCI Thesaurus Property
    C25462
    NCI Thesaurus Property-2
    C25364
    Coordinating Group Code
    Descrizione

    Coordinating Group Code

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C25162
    UMLS CUI-1
    C1711341
    NCI Thesaurus ObjectClass
    C17005
    UMLS CUI-2
    C0805701
    NCI Thesaurus ObjectClass-2
    C25462
    NCI Thesaurus Property
    C25364
    Protocol Title
    Descrizione

    Protocol Title

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS CUI-1
    C2986303
    NCI Thesaurus ObjectClass
    C25320
    NCI Thesaurus Property
    C42774
    Patient Study ID
    Descrizione

    Patient Study ID

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C2348585
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25462
    NCI Thesaurus Property-2
    C25364
    Registering Group Code
    Descrizione

    Registering Group Code

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C25162
    UMLS CUI-1
    C2347449
    NCI Thesaurus ObjectClass
    C17005
    UMLS CUI-2
    C0805701
    NCI Thesaurus Property
    C25364
    NCI Thesaurus ObjectClass-2
    C25645
    Patient Medical Record Number
    Descrizione

    Medical Record Number

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C1301894
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25261
    NCI Thesaurus Property-2
    C25198
    Other Patient ID
    Descrizione

    Trial subject ID Participating Group

    Tipo di dati

    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
    Institution/Affiliate
    Descrizione

    Institution Name

    Tipo di dati

    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
    Registering Institution Code
    Descrizione

    Registering Institution Code

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C25162
    UMLS CUI-1
    C1301943
    NCI Thesaurus ObjectClass
    C21541
    UMLS CUI-2
    C0805701
    NCI Thesaurus Property
    C25364
    NCI Thesaurus ObjectClass-2
    C25645
    Physician of Record
    Descrizione

    Investigator Name

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS CUI-1
    C2826892
    NCI Thesaurus Property
    C25364
    NCI Thesaurus ObjectClass
    C17089
    NCI Thesaurus ObjectClass-2
    C25644
    Form Administration
    Descrizione

    Form Administration

    Person Completing Form
    Descrizione

    Person Completing Form

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS CUI-1
    C1550483
    NCI Thesaurus ObjectClass
    C25657
    NCI Thesaurus Property
    C25364
    Date Form Completed
    Descrizione

    Date Form Completed

    Tipo di dati

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS CUI-1
    C1115437
    NCI Thesaurus ObjectClass
    C40988
    NCI Thesaurus Property
    C25250
    NCI Thesaurus ValueDomain-2
    C25367
    Are data amended (If data are amended, please circle in red when using paper form.)
    Descrizione

    Data amended

    Tipo di dati

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS CUI-1
    C0680532
    NCI Thesaurus ObjectClass
    C25474
    NCI Thesaurus Property
    C25416
    Reporting Period Start Date (mm dd yyyy)
    Descrizione

    Reporting Period Start Date

    Tipo di dati

    date

    Alias
    NCI Thesaurus ObjectClass
    C15368
    NCI Thesaurus Property
    C25616
    UMLS CUI-1
    C2361257
    NCI Thesaurus Property-2
    C25651
    NCI Thesaurus ValueDomain
    C25164
    NCI Thesaurus ValueDomain-2
    C25431
    Reporting Period End Date (mm dd yyyy)
    Descrizione

    Reporting Period End Date

    Tipo di dati

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS CUI-1
    C2361259
    NCI Thesaurus Property
    C25616
    NCI Thesaurus ObjectClass
    C15368
    NCI Thesaurus Property-2
    C25651
    Date of Last Clinical Assessment (mm dd yyyy)
    Descrizione

    Follow-Up Date

    Tipo di dati

    date

    Alias
    NCI Thesaurus ObjectClass
    C9305
    UMLS CUI-1
    C3694716
    NCI Thesaurus Property
    C16033
    NCI Thesaurus Property-2
    C25365
    NCI Thesaurus ValueDomain
    C25164
    NCI Thesaurus ValueDomain-2
    C25367
    Response Assessment
    Descrizione

    Response Assessment

    Has the patient achieved a response?
    Descrizione

    TumorResponseInd-3

    Tipo di dati

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    NCI Thesaurus ObjectClass
    C3262
    UMLS 2011AA ObjectClass
    C0027651
    NCI Thesaurus Property
    C25755
    UMLS 2011AA Property
    C0871261
    NCI Thesaurus ValueDomain-2
    C25755
    UMLS 2011AA ValueDomain-2
    C0871261
    Partial Response (PR) First Observed Date (mm dd yyyy)
    Descrizione

    Partial Response First Observed Date

    Tipo di dati

    date

    Alias
    NCI Thesaurus ObjectClass
    C25755
    UMLS CUI-1
    C1521726
    NCI Thesaurus ObjectClass-2
    C25378
    UMLS CUI-2
    C1115465
    NCI Thesaurus Property
    C25509
    NCI Thesaurus Property-2
    C25599
    NCI Thesaurus ValueDomain
    C25164
    NCI Thesaurus ValueDomain-2
    C25367
    Complete Response (CR) First Observed Date (mm dd yyyy)
    Descrizione

    Complete Response First Observed Date

    Tipo di dati

    date

    Alias
    NCI Thesaurus ObjectClass
    C25755
    UMLS CUI-1
    C0677874
    NCI Thesaurus ObjectClass-2
    C25250
    UMLS CUI-2
    C1115465
    NCI Thesaurus Property
    C25509
    NCI Thesaurus Property-2
    C25599
    NCI Thesaurus ValueDomain
    C25164
    NCI Thesaurus ValueDomain-2
    C25367
    Has the patient been diagnosed with a new progression? (during this reporting period not previously reported)
    Descrizione

    DiseaseNewProgressionInd-2

    Tipo di dati

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    NCI Thesaurus Property
    C25586
    UMLS 2011AA Property
    C0205314
    NCI Thesaurus Property-2
    C25331
    NCI Thesaurus ObjectClass
    C2991
    UMLS 2011AA ObjectClass
    C0012634
    Progressive Disease (PD) Observed Date (mm dd yyyy)
    Descrizione

    Progressive Disease Observed Date

    Tipo di dati

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS CUI-1
    C1335499
    NCI Thesaurus ValueDomain-2
    C25367
    NCI Thesaurus ObjectClass
    C25331
    NCI Thesaurus Property
    C25599
    UMLS CUI-2
    C0011008
    Progressive Disease Documentation (Note: Record all anatomic sites of progression on the Follow-Up form for the specific disease being treated.)
    Descrizione

    ProgressionCriteriaType

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    NCI Thesaurus ObjectClass
    C25331
    NCI Thesaurus Property
    C25466
    UMLS 2011AA Property
    C0243161
    Other specify
    Descrizione

    ProgressionCriteriaSpecify

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C25685
    UMLS 2011AA ValueDomain
    C1521902
    NCI Thesaurus ObjectClass
    C25331
    NCI Thesaurus Property
    C25466
    UMLS 2011AA Property
    C0243161
    Date Response Last Documented (mm dd yyyy)
    Descrizione

    ResponseLastDocumentedDate

    Tipo di dati

    date

    Alias
    NCI Thesaurus ObjectClass
    C25755
    UMLS 2011AA ObjectClass
    C0871261
    NCI Thesaurus Property
    C25551
    UMLS 2011AA Property
    C1517741
    NCI Thesaurus Property-2
    C25356
    UMLS 2011AA Property-2
    C1301725
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ValueDomain-2
    C25367
    Comments
    Descrizione

    Comments

    Comments
    Descrizione

    Research Comments

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C25704
    UMLS CUI-1
    C0947611
    NCI Thesaurus ObjectClass
    C15319
    NCI Thesaurus Property
    C25393
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    Similar models

    [Optional Form ? May be selected by specific disease committees where appropriate.]

    1 moduli
    1. StudyEvent: Phase II Breast Cancer - Summary Response/Progression Form for Solid Tumors
      1. [Optional Form ? May be selected by specific disease committees where appropriate.]
    Name
    genere
    Description | Question | Decode (Coded Value)
    Tipo di dati
    Alias
    Item Group
    Crf Header
    Protocol ID Coordinating Group
    Item
    Coordinating Group Protocol No.
    text
    C25337 (NCI Thesaurus ValueDomain)
    C3274381 (UMLS CUI-1)
    C25320 (NCI Thesaurus ObjectClass)
    C1711341 (UMLS CUI-2)
    C25462 (NCI Thesaurus Property)
    C25364 (NCI Thesaurus Property-2)
    Coordinating Group Code
    Item
    Coordinating Group Code
    text
    C25162 (NCI Thesaurus ValueDomain)
    C1711341 (UMLS CUI-1)
    C17005 (NCI Thesaurus ObjectClass)
    C0805701 (UMLS CUI-2)
    C25462 (NCI Thesaurus ObjectClass-2)
    C25364 (NCI Thesaurus Property)
    Protocol Title
    Item
    Protocol Title
    text
    C25191 (NCI Thesaurus ValueDomain)
    C2986303 (UMLS CUI-1)
    C25320 (NCI Thesaurus ObjectClass)
    C42774 (NCI Thesaurus Property)
    Patient Study ID
    Item
    Patient Study ID
    text
    C25337 (NCI Thesaurus ValueDomain)
    C2348585 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C25462 (NCI Thesaurus Property)
    C25364 (NCI Thesaurus Property-2)
    Registering Group Code
    Item
    Registering Group Code
    text
    C25162 (NCI Thesaurus ValueDomain)
    C2347449 (UMLS CUI-1)
    C17005 (NCI Thesaurus ObjectClass)
    C0805701 (UMLS CUI-2)
    C25364 (NCI Thesaurus Property)
    C25645 (NCI Thesaurus ObjectClass-2)
    Medical Record Number
    Item
    Patient Medical Record Number
    text
    C25337 (NCI Thesaurus ValueDomain)
    C1301894 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C25261 (NCI Thesaurus Property)
    C25198 (NCI Thesaurus Property-2)
    Trial subject ID Participating Group
    Item
    Other Patient ID
    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)
    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)
    Registering Institution Code
    Item
    Registering Institution Code
    text
    C25162 (NCI Thesaurus ValueDomain)
    C1301943 (UMLS CUI-1)
    C21541 (NCI Thesaurus ObjectClass)
    C0805701 (UMLS CUI-2)
    C25364 (NCI Thesaurus Property)
    C25645 (NCI Thesaurus ObjectClass-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)
    Item Group
    Form Administration
    Person Completing Form
    Item
    Person Completing Form
    text
    C25191 (NCI Thesaurus ValueDomain)
    C1550483 (UMLS CUI-1)
    C25657 (NCI Thesaurus ObjectClass)
    C25364 (NCI Thesaurus Property)
    Date Form Completed
    Item
    Date Form Completed
    date
    C25164 (NCI Thesaurus ValueDomain)
    C1115437 (UMLS CUI-1)
    C40988 (NCI Thesaurus ObjectClass)
    C25250 (NCI Thesaurus Property)
    C25367 (NCI Thesaurus ValueDomain-2)
    Data amended
    Item
    Are data amended (If data are amended, please circle in red when using paper form.)
    boolean
    C38148 (NCI Thesaurus ValueDomain)
    C0680532 (UMLS CUI-1)
    C25474 (NCI Thesaurus ObjectClass)
    C25416 (NCI Thesaurus Property)
    Reporting Period Start Date
    Item
    Reporting Period Start Date (mm dd yyyy)
    date
    C15368 (NCI Thesaurus ObjectClass)
    C25616 (NCI Thesaurus Property)
    C2361257 (UMLS CUI-1)
    C25651 (NCI Thesaurus Property-2)
    C25164 (NCI Thesaurus ValueDomain)
    C25431 (NCI Thesaurus ValueDomain-2)
    Reporting Period End Date
    Item
    Reporting Period End Date (mm dd yyyy)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C2361259 (UMLS CUI-1)
    C25616 (NCI Thesaurus Property)
    C15368 (NCI Thesaurus ObjectClass)
    C25651 (NCI Thesaurus Property-2)
    Follow-Up Date
    Item
    Date of Last Clinical Assessment (mm dd yyyy)
    date
    C9305 (NCI Thesaurus ObjectClass)
    C3694716 (UMLS CUI-1)
    C16033 (NCI Thesaurus Property)
    C25365 (NCI Thesaurus Property-2)
    C25164 (NCI Thesaurus ValueDomain)
    C25367 (NCI Thesaurus ValueDomain-2)
    Item Group
    Response Assessment
    TumorResponseInd-3
    Item
    Has the patient achieved a response?
    boolean
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    C3262 (NCI Thesaurus ObjectClass)
    C0027651 (UMLS 2011AA ObjectClass)
    C25755 (NCI Thesaurus Property)
    C0871261 (UMLS 2011AA Property)
    C25755 (NCI Thesaurus ValueDomain-2)
    C0871261 (UMLS 2011AA ValueDomain-2)
    Partial Response First Observed Date
    Item
    Partial Response (PR) First Observed Date (mm dd yyyy)
    date
    C25755 (NCI Thesaurus ObjectClass)
    C1521726 (UMLS CUI-1)
    C25378 (NCI Thesaurus ObjectClass-2)
    C1115465 (UMLS CUI-2)
    C25509 (NCI Thesaurus Property)
    C25599 (NCI Thesaurus Property-2)
    C25164 (NCI Thesaurus ValueDomain)
    C25367 (NCI Thesaurus ValueDomain-2)
    Complete Response First Observed Date
    Item
    Complete Response (CR) First Observed Date (mm dd yyyy)
    date
    C25755 (NCI Thesaurus ObjectClass)
    C0677874 (UMLS CUI-1)
    C25250 (NCI Thesaurus ObjectClass-2)
    C1115465 (UMLS CUI-2)
    C25509 (NCI Thesaurus Property)
    C25599 (NCI Thesaurus Property-2)
    C25164 (NCI Thesaurus ValueDomain)
    C25367 (NCI Thesaurus ValueDomain-2)
    DiseaseNewProgressionInd-2
    Item
    Has the patient been diagnosed with a new progression? (during this reporting period not previously reported)
    boolean
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    C25586 (NCI Thesaurus Property)
    C0205314 (UMLS 2011AA Property)
    C25331 (NCI Thesaurus Property-2)
    C2991 (NCI Thesaurus ObjectClass)
    C0012634 (UMLS 2011AA ObjectClass)
    Progressive Disease Observed Date
    Item
    Progressive Disease (PD) Observed Date (mm dd yyyy)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C1335499 (UMLS CUI-1)
    C25367 (NCI Thesaurus ValueDomain-2)
    C25331 (NCI Thesaurus ObjectClass)
    C25599 (NCI Thesaurus Property)
    C0011008 (UMLS CUI-2)
    Item
    Progressive Disease Documentation (Note: Record all anatomic sites of progression on the Follow-Up form for the specific disease being treated.)
    text
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    C25331 (NCI Thesaurus ObjectClass)
    C25466 (NCI Thesaurus Property)
    C0243161 (UMLS 2011AA Property)
    CL.4
    Code List
    Progressive Disease Documentation (Note: Record all anatomic sites of progression on the Follow-Up form for the specific disease being treated.)
    CL Item
    Target Lesions (at Least A 20% Increase In The Sum Of Longest Diameters Of Target Lesions, Taking As Reference The Smallest Sum Recorded Since The Treatment Started) (Target Lesions)
    CL Item
    Nontarget Lesions (unequivocal Progression Of Existing Nontarget Lesions) (Nontarget Lesions)
    CL Item
    Progressive Disease Defined By New Lesions (Appearance of one or more new lesions)
    CL Item
    Other, Specify (Other)
    ProgressionCriteriaSpecify
    Item
    Other specify
    text
    C25685 (NCI Thesaurus ValueDomain)
    C1521902 (UMLS 2011AA ValueDomain)
    C25331 (NCI Thesaurus ObjectClass)
    C25466 (NCI Thesaurus Property)
    C0243161 (UMLS 2011AA Property)
    ResponseLastDocumentedDate
    Item
    Date Response Last Documented (mm dd yyyy)
    date
    C25755 (NCI Thesaurus ObjectClass)
    C0871261 (UMLS 2011AA ObjectClass)
    C25551 (NCI Thesaurus Property)
    C1517741 (UMLS 2011AA Property)
    C25356 (NCI Thesaurus Property-2)
    C1301725 (UMLS 2011AA Property-2)
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C25367 (NCI Thesaurus ValueDomain-2)
    Item Group
    Comments
    Research Comments
    Item
    Comments
    text
    C25704 (NCI Thesaurus ValueDomain)
    C0947611 (UMLS CUI-1)
    C15319 (NCI Thesaurus ObjectClass)
    C25393 (NCI Thesaurus Property)
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