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7319

Beschreibung

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

Stichworte

Versionen (2)
  1. 27.08.12 27.08.12 -
  2. 09.01.15 09.01.15 - Martin Dugas
Hochgeladen am

9. Januar 2015

DOI

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    Breast Cancer NCT01272037 Pre-Study - S1007 Prestudy Form - Randomized Study (6230) - 3141162v1.0

    Englisch

    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 Formulare  
    Header
    Beschreibung

    Header

    SWOG Patient ID
    Beschreibung

    Trial subject ID SWOG

    Datentyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C2348585
    NCI Thesaurus ObjectClass
    C16960
    UMLS CUI-2
    C1519429
    NCI Thesaurus Property
    C25364
    NCI Thesaurus Property-2
    C25699
    SWOG Study No.
    Beschreibung

    Protocol ID SWOG

    Datentyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C3274381
    NCI Thesaurus ObjectClass
    C25320
    UMLS CUI-2
    C1519429
    NCI Thesaurus Property
    C25364
    NCI Thesaurus Property-2
    C25699
    Registration Step
    Beschreibung

    Registration Number

    Datentyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C1514821
    NCI Thesaurus ObjectClass
    C25646
    UMLS CUI-2
    C0237753
    NCI Thesaurus Property
    C16154
    NCI Thesaurus ValueDomain-2
    C16154
    Patient Initials (L, F M)
    Beschreibung

    Patient Initials

    Datentyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS CUI-1
    C2986440
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25536
    Institution/Affiliate
    Beschreibung

    Institution Name

    Datentyp

    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
    Beschreibung

    Investigator Name

    Datentyp

    text

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

    Participating Group

    Datentyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS CUI-1
    C2347449
    NCI Thesaurus ObjectClass
    C25608
    NCI Thesaurus ObjectClass-2
    C17005
    NCI Thesaurus Property
    C25364
    Participating Group Study No.
    Beschreibung

    Study Number Participating Group

    Datentyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C3274381
    NCI Thesaurus ObjectClass
    C25320
    UMLS CUI-2
    C2347449
    NCI Thesaurus Property
    C25608
    NCI Thesaurus Property-2
    C25364
    Participating Group Patient ID
    Beschreibung

    Trial subject ID Participating Group

    Datentyp

    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
    Patient And Disease Description
    Beschreibung

    Patient And Disease Description

    Oncotype DX Recurrence Score
    Beschreibung

    LaboratoryProcedureOncotypeDXBreastCancerAssayResultScore

    Datentyp

    float

    Alias
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus Property-2
    C52159
    UMLS 2011AA Property-2
    C1709318
    NCI Thesaurus ValueDomain
    C25338
    UMLS 2011AA ValueDomain
    C0449820
    Oncotype DX ER Score
    Beschreibung

    LaboratoryProcedureOncotypeDXBreastCancerAssayEstrogenReceptorStatusResultScore

    Datentyp

    float

    Alias
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    NCI Thesaurus Property-2
    C52159
    UMLS 2011AA Property-2
    C1709318
    NCI Thesaurus Property-3
    C16150
    UMLS 2011AA Property-3
    C1516974
    NCI Thesaurus ValueDomain
    C25338
    UMLS 2011AA ValueDomain
    C0449820
    Oncotype DX PR Score
    Beschreibung

    LaboratoryProcedureOncotypeDXBreastCancerAssayProgesteroneReceptorStatusResultScore

    Datentyp

    float

    Alias
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    NCI Thesaurus Property-2
    C52159
    UMLS 2011AA Property-2
    C1709318
    NCI Thesaurus Property-3
    C16149
    UMLS 2011AA Property-3
    C1514471
    NCI Thesaurus ValueDomain
    C25338
    UMLS 2011AA ValueDomain
    C0449820
    Oncotype DX HER2 Score
    Beschreibung

    LaboratoryProcedureOncotypeDXBreastCancerAssayHER2ResultScore

    Datentyp

    float

    Alias
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    NCI Thesaurus Property-2
    C17756
    UMLS 2011AA Property-2
    C0242957
    NCI Thesaurus Property-3
    C52159
    UMLS 2011AA Property-3
    C1709318
    NCI Thesaurus ValueDomain
    C25338
    UMLS 2011AA ValueDomain
    C0449820
    Requisition Number
    Beschreibung

    PatientOncotypeDXBreastCancerAssayIdentifierNumber

    Datentyp

    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-2
    C52159
    UMLS 2011AA Property-2
    C1709318
    Date of Oncotype DX Score Report (MM DD YYYY)
    Beschreibung

    LaboratoryProcedureOncotypeDXBreastCancerAssayResultDate

    Datentyp

    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-2
    C52159
    UMLS 2011AA Property-2
    C1709318
    Has the patient suggested or indicated that she will not follow the randomized treatment assignment
    Beschreibung

    PatientNoRandomizationInd-2

    Datentyp

    boolean

    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-2
    C25196
    UMLS 2011AA Property-2
    C0034656
    Indicate Reason (If yes)
    Beschreibung

    PatientNoRandomizationReason

    Datentyp

    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-2
    C25196
    UMLS 2011AA Property-2
    C0034656
    Comments
    Beschreibung

    Comments

    Comments
    Beschreibung

    Research Comments

    Datentyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25704
    UMLS CUI-1
    C0947611
    NCI Thesaurus ObjectClass
    C15319
    NCI Thesaurus Property
    C25393
    Zum Seitenanfang zurückkehren

    Ähnliche Modelle

    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 Formulare
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    Header
    Trial subject ID SWOG
    Item
    SWOG Patient ID
    text
    C25337 (NCI Thesaurus ValueDomain)
    C2348585 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C1519429 (UMLS CUI-2)
    C25364 (NCI Thesaurus Property)
    C25699 (NCI Thesaurus Property-2)
    Protocol ID SWOG
    Item
    SWOG Study No.
    text
    C25337 (NCI Thesaurus ValueDomain)
    C3274381 (UMLS CUI-1)
    C25320 (NCI Thesaurus ObjectClass)
    C1519429 (UMLS CUI-2)
    C25364 (NCI Thesaurus Property)
    C25699 (NCI Thesaurus Property-2)
    Registration Number
    Item
    Registration Step
    text
    C25337 (NCI Thesaurus ValueDomain)
    C1514821 (UMLS CUI-1)
    C25646 (NCI Thesaurus ObjectClass)
    C0237753 (UMLS CUI-2)
    C16154 (NCI Thesaurus Property)
    C16154 (NCI Thesaurus ValueDomain-2)
    Patient Initials
    Item
    Patient Initials (L, F M)
    text
    C25191 (NCI Thesaurus ValueDomain)
    C2986440 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C25536 (NCI Thesaurus 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
    text
    C25191 (NCI Thesaurus ValueDomain)
    C2826892 (UMLS CUI-1)
    C25364 (NCI Thesaurus Property)
    C17089 (NCI Thesaurus ObjectClass)
    C25644 (NCI Thesaurus ObjectClass-2)
    Participating Group
    Item
    Participating Group Name
    text
    C25191 (NCI Thesaurus ValueDomain)
    C2347449 (UMLS CUI-1)
    C25608 (NCI Thesaurus ObjectClass)
    C17005 (NCI Thesaurus ObjectClass-2)
    C25364 (NCI Thesaurus Property)
    Study Number Participating Group
    Item
    Participating Group Study No.
    text
    C25337 (NCI Thesaurus ValueDomain)
    C3274381 (UMLS CUI-1)
    C25320 (NCI Thesaurus ObjectClass)
    C2347449 (UMLS CUI-2)
    C25608 (NCI Thesaurus Property)
    C25364 (NCI Thesaurus Property-2)
    Trial subject ID Participating Group
    Item
    Participating Group 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)
    Item Group
    Patient And Disease Description
    LaboratoryProcedureOncotypeDXBreastCancerAssayResultScore
    Item
    Oncotype DX Recurrence Score
    float
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C52159 (NCI Thesaurus Property-2)
    C1709318 (UMLS 2011AA Property-2)
    C25338 (NCI Thesaurus ValueDomain)
    C0449820 (UMLS 2011AA ValueDomain)
    LaboratoryProcedureOncotypeDXBreastCancerAssayEstrogenReceptorStatusResultScore
    Item
    Oncotype DX ER Score
    float
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    C52159 (NCI Thesaurus Property-2)
    C1709318 (UMLS 2011AA Property-2)
    C16150 (NCI Thesaurus Property-3)
    C1516974 (UMLS 2011AA Property-3)
    C25338 (NCI Thesaurus ValueDomain)
    C0449820 (UMLS 2011AA ValueDomain)
    LaboratoryProcedureOncotypeDXBreastCancerAssayProgesteroneReceptorStatusResultScore
    Item
    Oncotype DX PR Score
    float
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    C52159 (NCI Thesaurus Property-2)
    C1709318 (UMLS 2011AA Property-2)
    C16149 (NCI Thesaurus Property-3)
    C1514471 (UMLS 2011AA Property-3)
    C25338 (NCI Thesaurus ValueDomain)
    C0449820 (UMLS 2011AA ValueDomain)
    LaboratoryProcedureOncotypeDXBreastCancerAssayHER2ResultScore
    Item
    Oncotype DX HER2 Score
    float
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    C17756 (NCI Thesaurus Property-2)
    C0242957 (UMLS 2011AA Property-2)
    C52159 (NCI Thesaurus Property-3)
    C1709318 (UMLS 2011AA Property-3)
    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-2)
    C1709318 (UMLS 2011AA Property-2)
    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-2)
    C1709318 (UMLS 2011AA Property-2)
    PatientNoRandomizationInd-2
    Item
    Has the patient suggested or indicated that she will not follow the randomized treatment assignment
    boolean
    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-2)
    C0034656 (UMLS 2011AA Property-2)
    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-2)
    C0034656 (UMLS 2011AA Property-2)
    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
    Research Comments
    Item
    Comments
    text
    C25704 (NCI Thesaurus ValueDomain)
    C0947611 (UMLS CUI-1)
    C15319 (NCI Thesaurus ObjectClass)
    C25393 (NCI Thesaurus Property)
    Zum Seitenanfang zurückkehren 

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