ID

8978

Description

Southwest Oncology Group S0600 Registration Worksheet Irinotecan and Cetuximab With or Without Bevacizumab in Treating Patients With Metastatic Colorectal Cancer That Progressed During First-Line Therapy Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=7E16B1D7-6F02-2C29-E040-BB89AD4317D7

Lien

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=7E16B1D7-6F02-2C29-E040-BB89AD4317D7

Mots-clés

  1. 27/08/2012 27/08/2012 -
  2. 09/01/2015 09/01/2015 - Martin Dugas
Téléchargé le

9 janvier 2015

DOI

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Licence

Creative Commons BY-NC 3.0 Legacy

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    Colorectal Cancer NCT00499369 Registration - Southwest Oncology Group S0600 Registration Worksheet - 2994609v1.0

    INSTRUCTIONS: All of the information on this Registration Worksheet and the Protocol Eligibility Section must be answered appropriately for a patient to be considered eligible for registration. This Registration Worksheet must be entirely filled out and referred to during the registration. Do NOT submit this worksheet as part of the patient data.

    Unnamed2
    Description

    Unnamed2

    SWOG Patient ID Status
    Description

    PatientSouthwestOncologyGroupIdentifierStatus

    Type de données

    text

    Alias
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    NCI Thesaurus Property-2
    C25699
    UMLS 2011AA Property-2
    C1519429
    NCI Thesaurus ValueDomain
    C25688
    UMLS 2011AA ValueDomain
    C0449438
    SWOG Patient ID
    Description

    Trial subject ID SWOG

    Type de données

    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
    Unnamed5
    Description

    Unnamed5

    Patient First Name
    Description

    First Name

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS CUI-1
    C1443235
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25364
    NCI Thesaurus Property-2
    C25509
    Patient Middle Name
    Description

    PatientMiddleName

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS 2011AA ValueDomain
    C1547383
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    NCI Thesaurus Property-2
    C25569
    UMLS 2011AA Property-2
    C0444598
    Patient Last Name
    Description

    Last Name

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS CUI-1
    C1301584
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25364
    NCI Thesaurus Property-2
    C25551
    Unnamed4
    Description

    Unnamed4

    Registrar's SWOG Roster ID Number
    Description

    RegistrarSouthwestOncologyGroupIdentifierNumber

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS 2011AA ValueDomain
    C0237753
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    NCI Thesaurus Property-2
    C25699
    UMLS 2011AA Property-2
    C1519429
    NCI Thesaurus ObjectClass
    C25357
    UMLS 2011AA ObjectClass
    C0557514
    SWOG Investigator Number
    Description

    SouthwestOncologyGroupInvestigatorIdentifierNumber

    Type de données

    float

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS 2011AA ValueDomain
    C0237753
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    NCI Thesaurus ObjectClass
    C25699
    UMLS 2011AA ObjectClass
    C1519429
    NCI Thesaurus ObjectClass-2
    C17089
    UMLS 2011AA ObjectClass-2
    C0035173
    SWOG Treating Institution Number
    Description

    SouthwestOncologyGroupTreatingInstitutionIdentifierNumber

    Type de données

    float

    Alias
    NCI Thesaurus ObjectClass
    C25699
    UMLS 2011AA ObjectClass
    C1519429
    NCI Thesaurus ObjectClass-2
    C25705
    UMLS 2011AA ObjectClass-2
    C1522326
    NCI Thesaurus ObjectClass-3
    C41206
    UMLS 2011AA ObjectClass-3
    C1272753
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    NCI Thesaurus ValueDomain
    C25337
    UMLS 2011AA ValueDomain
    C0237753
    Patient Information
    Description

    Patient Information

    Date Informed Consent Signed
    Description

    InformedConsentFormSignedDate

    Type de données

    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
    Date HIPAA Authorization signed (Not required if Country of Residence is not USA)
    Description

    HIPAA Approval Date

    Type de données

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS CUI-1
    C0600593
    NCI Thesaurus ObjectClass
    C25320
    UMLS CUI-2
    C2346844
    NCI Thesaurus Property
    C25425
    Projected Start Date of Treatment
    Description

    Treatment Begin Date

    Type de données

    date

    Alias
    NCI Thesaurus ObjectClass
    C15368
    NCI Thesaurus ObjectClass-2
    C25631
    NCI Thesaurus Property
    C25431
    UMLS CUI-1
    C3173309
    NCI Thesaurus Property-2
    C25275
    NCI Thesaurus ValueDomain
    C25164
    NCI Thesaurus ValueDomain-2
    C25431
    Stratification Questions
    Description

    Stratification Questions

    Performance status
    Description

    PerformanceStatusAssessmentPerformanceStatusStratificationCode

    Type de données

    float

    Alias
    NCI Thesaurus ValueDomain
    C25162
    UMLS 2011AA ValueDomain
    C0805701
    NCI Thesaurus Property
    C25367
    NCI Thesaurus ObjectClass
    C20641
    UMLS 2011AA ObjectClass
    C1518965
    NCI Thesaurus ValueDomain-2
    C25689
    UMLS 2011AA ValueDomain-2
    C1514983
    Discontinuation of oxaliplatin while on first line therapy
    Description

    OxaliplatinFirst-LineTherapyDiscontinueCode

    Type de données

    float

    Alias
    NCI Thesaurus ValueDomain
    C25162
    UMLS 2011AA ValueDomain
    C0805701
    NCI Thesaurus ObjectClass
    C1181
    UMLS 2011AA ObjectClass
    C0069717
    NCI Thesaurus Property
    C25484
    UMLS 2011AA Property
    C1444662
    NCI Thesaurus ObjectClass-2
    C45792
    UMLS 2011AA ObjectClass-2
    C1708063
    Planned concurrent chemotherapy
    Description

    ClinicalStudyProtocolConcurrentChemotherapyPlanStratificationCode

    Type de données

    text

    Alias
    NCI Thesaurus ObjectClass
    C25320
    UMLS 2011AA ObjectClass
    C1507394
    NCI Thesaurus Property
    C15632
    UMLS 2011AA Property
    C0392920
    NCI Thesaurus Property-2
    C25619
    UMLS 2011AA Property-2
    C1301732
    NCI Thesaurus Property-3
    C25456
    UMLS 2011AA Property-3
    C0205420
    NCI Thesaurus Property-4
    C25689
    UMLS 2011AA Property-4
    C1514983
    NCI Thesaurus ValueDomain
    C25162
    UMLS 2011AA ValueDomain
    C0805701
    Time from last dose of bevacizumab
    Description

    ClinicalStudyProtocolBevacizumabLastAdministrationStratificationDuration

    Type de données

    text

    Alias
    NCI Thesaurus ObjectClass
    C25320
    UMLS 2011AA ObjectClass
    C1507394
    NCI Thesaurus Property
    C2039
    UMLS 2011AA Property
    C0796392
    NCI Thesaurus Property-2
    C25551
    UMLS 2011AA Property-2
    C1517741
    NCI Thesaurus Property-3
    C25409
    UMLS 2011AA Property-3
    C1533734
    NCI Thesaurus Property-4
    C25689
    UMLS 2011AA Property-4
    C1514983
    NCI Thesaurus ValueDomain
    C25330
    UMLS 2011AA ValueDomain
    C0449238
    Unnamed4
    Description

    Unnamed4

    I agree to allow my study doctor, or someone approved by my study doctor, to contact me regarding future research involving my participation in this study
    Description

    SouthwestOncologyGroupPatientResearchConsentInd-2

    Type de données

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus ObjectClass-2
    C25699
    UMLS 2011AA ObjectClass-2
    C1519429
    NCI Thesaurus Property
    C15319
    NCI Thesaurus Property-2
    C25460
    UMLS 2011AA Property
    C1511481
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    Patient Eligibility
    Description

    Patient Eligibility

    Has the Southwest Oncology Group Registration Worksheet been completed entirely and is the patient eligible according to the current version of protocol section 5.0
    Description

    SouthwestOncologyGroupPatientRegistrationEligibilityDeterminationInd-2

    Type de données

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus ObjectClass-2
    C25699
    UMLS 2011AA ObjectClass-2
    C1519429
    NCI Thesaurus Property
    C25646
    UMLS 2011AA Property
    C1514821
    NCI Thesaurus Property-2
    C25171
    UMLS 2011AA Property-2
    C0013893
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698

    Similar models

    INSTRUCTIONS: All of the information on this Registration Worksheet and the Protocol Eligibility Section must be answered appropriately for a patient to be considered eligible for registration. This Registration Worksheet must be entirely filled out and referred to during the registration. Do NOT submit this worksheet as part of the patient data.

    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    Alias
    Item Group
    Unnamed2
    Item
    SWOG Patient ID Status
    text
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    C25699 (NCI Thesaurus Property-2)
    C1519429 (UMLS 2011AA Property-2)
    C25688 (NCI Thesaurus ValueDomain)
    C0449438 (UMLS 2011AA ValueDomain)
    Code List
    SWOG Patient ID Status
    CL Item
    New Patient (New patient)
    CL Item
    Previous Patient (Previous patient)
    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)
    Item Group
    Unnamed5
    First Name
    Item
    Patient First Name
    text
    C25191 (NCI Thesaurus ValueDomain)
    C1443235 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C25364 (NCI Thesaurus Property)
    C25509 (NCI Thesaurus Property-2)
    PatientMiddleName
    Item
    Patient Middle Name
    text
    C25191 (NCI Thesaurus ValueDomain)
    C1547383 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    C25569 (NCI Thesaurus Property-2)
    C0444598 (UMLS 2011AA Property-2)
    Last Name
    Item
    Patient Last Name
    text
    C25191 (NCI Thesaurus ValueDomain)
    C1301584 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C25364 (NCI Thesaurus Property)
    C25551 (NCI Thesaurus Property-2)
    Item Group
    Unnamed4
    RegistrarSouthwestOncologyGroupIdentifierNumber
    Item
    Registrar's SWOG Roster ID Number
    text
    C25337 (NCI Thesaurus ValueDomain)
    C0237753 (UMLS 2011AA ValueDomain)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    C25699 (NCI Thesaurus Property-2)
    C1519429 (UMLS 2011AA Property-2)
    C25357 (NCI Thesaurus ObjectClass)
    C0557514 (UMLS 2011AA ObjectClass)
    SouthwestOncologyGroupInvestigatorIdentifierNumber
    Item
    SWOG Investigator Number
    float
    C25337 (NCI Thesaurus ValueDomain)
    C0237753 (UMLS 2011AA ValueDomain)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    C25699 (NCI Thesaurus ObjectClass)
    C1519429 (UMLS 2011AA ObjectClass)
    C17089 (NCI Thesaurus ObjectClass-2)
    C0035173 (UMLS 2011AA ObjectClass-2)
    SouthwestOncologyGroupTreatingInstitutionIdentifierNumber
    Item
    SWOG Treating Institution Number
    float
    C25699 (NCI Thesaurus ObjectClass)
    C1519429 (UMLS 2011AA ObjectClass)
    C25705 (NCI Thesaurus ObjectClass-2)
    C1522326 (UMLS 2011AA ObjectClass-2)
    C41206 (NCI Thesaurus ObjectClass-3)
    C1272753 (UMLS 2011AA ObjectClass-3)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    C25337 (NCI Thesaurus ValueDomain)
    C0237753 (UMLS 2011AA ValueDomain)
    Item Group
    Patient Information
    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)
    HIPAA Approval Date
    Item
    Date HIPAA Authorization signed (Not required if Country of Residence is not USA)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0600593 (UMLS CUI-1)
    C25320 (NCI Thesaurus ObjectClass)
    C2346844 (UMLS CUI-2)
    C25425 (NCI Thesaurus Property)
    Treatment Begin Date
    Item
    Projected Start Date of Treatment
    date
    C15368 (NCI Thesaurus ObjectClass)
    C25631 (NCI Thesaurus ObjectClass-2)
    C25431 (NCI Thesaurus Property)
    C3173309 (UMLS CUI-1)
    C25275 (NCI Thesaurus Property-2)
    C25164 (NCI Thesaurus ValueDomain)
    C25431 (NCI Thesaurus ValueDomain-2)
    Item Group
    Stratification Questions
    PerformanceStatusAssessmentPerformanceStatusStratificationCode
    Item
    Performance status
    float
    C25162 (NCI Thesaurus ValueDomain)
    C0805701 (UMLS 2011AA ValueDomain)
    C25367 (NCI Thesaurus Property)
    C20641 (NCI Thesaurus ObjectClass)
    C1518965 (UMLS 2011AA ObjectClass)
    C25689 (NCI Thesaurus ValueDomain-2)
    C1514983 (UMLS 2011AA ValueDomain-2)
    OxaliplatinFirst-LineTherapyDiscontinueCode
    Item
    Discontinuation of oxaliplatin while on first line therapy
    float
    C25162 (NCI Thesaurus ValueDomain)
    C0805701 (UMLS 2011AA ValueDomain)
    C1181 (NCI Thesaurus ObjectClass)
    C0069717 (UMLS 2011AA ObjectClass)
    C25484 (NCI Thesaurus Property)
    C1444662 (UMLS 2011AA Property)
    C45792 (NCI Thesaurus ObjectClass-2)
    C1708063 (UMLS 2011AA ObjectClass-2)
    Item
    Planned concurrent chemotherapy
    text
    C25320 (NCI Thesaurus ObjectClass)
    C1507394 (UMLS 2011AA ObjectClass)
    C15632 (NCI Thesaurus Property)
    C0392920 (UMLS 2011AA Property)
    C25619 (NCI Thesaurus Property-2)
    C1301732 (UMLS 2011AA Property-2)
    C25456 (NCI Thesaurus Property-3)
    C0205420 (UMLS 2011AA Property-3)
    C25689 (NCI Thesaurus Property-4)
    C1514983 (UMLS 2011AA Property-4)
    C25162 (NCI Thesaurus ValueDomain)
    C0805701 (UMLS 2011AA ValueDomain)
    Code List
    Planned concurrent chemotherapy
    CL Item
    Irinotecan + 5-fluorouracil/leucovorin Regimen (folfiri) (1)
    CL Item
    Single Agent Irinotecan (2)
    Item
    Time from last dose of bevacizumab
    text
    C25320 (NCI Thesaurus ObjectClass)
    C1507394 (UMLS 2011AA ObjectClass)
    C2039 (NCI Thesaurus Property)
    C0796392 (UMLS 2011AA Property)
    C25551 (NCI Thesaurus Property-2)
    C1517741 (UMLS 2011AA Property-2)
    C25409 (NCI Thesaurus Property-3)
    C1533734 (UMLS 2011AA Property-3)
    C25689 (NCI Thesaurus Property-4)
    C1514983 (UMLS 2011AA Property-4)
    C25330 (NCI Thesaurus ValueDomain)
    C0449238 (UMLS 2011AA ValueDomain)
    Code List
    Time from last dose of bevacizumab
    CL Item
    14-42 Days (1)
    CL Item
    43 Days Or Higher (2)
    SouthwestOncologyGroupPatientResearchConsentInd-2
    Item
    I agree to allow my study doctor, or someone approved by my study doctor, to contact me regarding future research involving my participation in this study
    boolean
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25699 (NCI Thesaurus ObjectClass-2)
    C1519429 (UMLS 2011AA ObjectClass-2)
    C15319 (NCI Thesaurus Property)
    C25460 (NCI Thesaurus Property-2)
    C1511481 (UMLS 2011AA Property)
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    Item Group
    Patient Eligibility
    SouthwestOncologyGroupPatientRegistrationEligibilityDeterminationInd-2
    Item
    Has the Southwest Oncology Group Registration Worksheet been completed entirely and is the patient eligible according to the current version of protocol section 5.0
    boolean
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25699 (NCI Thesaurus ObjectClass-2)
    C1519429 (UMLS 2011AA ObjectClass-2)
    C25646 (NCI Thesaurus Property)
    C1514821 (UMLS 2011AA Property)
    C25171 (NCI Thesaurus Property-2)
    C0013893 (UMLS 2011AA Property-2)
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)

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