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6613

Description

ACOSOG-Z4099 End of Intervention Form Surgery With or Without Internal Radiation Therapy Compared With Stereotactic Body Radiation Therapy in Treating Patients With High-Risk Stage I Non-Small Cell Lung Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=9869A599-BCAB-139E-E040-BB89AD432862

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=9869A599-BCAB-139E-E040-BB89AD432862

Keywords

  1. 9/19/12 9/19/12 -
  2. 1/8/15 1/8/15 - Martin Dugas
  3. 1/9/15 1/9/15 - Martin Dugas
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January 8, 2015

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Creative Commons BY-NC 3.0 Legacy

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    Lung Cancer NCT01336894 Off Treatment - ACOSOG-Z4099 End of Intervention Form - 3178441v1.0

    ALL ITEMS MUST BE COMPLETED

    1. StudyEvent: ACOSOG-Z4099 End of Intervention Form
      1. ALL ITEMS MUST BE COMPLETED
    Header Module
    Description

    Header Module

    Protocol Number
    Description

    ProtocolACOSOGIdentifierNumber

    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-2
    C19712
    UMLS 2011AA Property-2
    C1515944
    Patient ID
    Description

    Patient Study ID

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C2348585
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25462
    NCI Thesaurus Property-2
    C25364
    Patient Initials (L F M)
    Description

    Patient Initials

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS CUI-1
    C2986440
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25536
    Institution Number
    Description

    Institution Number

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C1301943
    NCI Thesaurus ObjectClass
    C21541
    UMLS CUI-2
    C0805701
    NCI Thesaurus Property
    C25364
    Institution
    Description

    Institution Name

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS CUI-1
    C1301943
    NCI Thesaurus ObjectClass
    C21541
    NCI Thesaurus ValueDomain-2
    C21541
    NCI Thesaurus Property
    C25364
    Are data amended (check one if data amended, please circle in red when using paper forms)
    Description

    Data amended

    Data type

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS CUI-1
    C0680532
    NCI Thesaurus ObjectClass
    C25474
    NCI Thesaurus Property
    C25416
    Preregistration Screening Failure
    Description

    Preregistration Screening Failure

    Last Date (any modality of) protocol therapy was given (dd MMM yyyy date of surgery or last SBRT fraction on this study or date decision made not to initiate protocol treatment)
    Description

    Treatment End Date

    Data type

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS CUI-1
    C1531784
    NCI Thesaurus ObjectClass
    C15368
    NCI Thesaurus Property
    C25275
    NCI Thesaurus Property-2
    C25496
    Off Treatment Date (dd MMM yyyy date decision was made to end active treatment or not to initiate protocol treatment)
    Description

    OffTreatmentDate

    Data type

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ObjectClass
    C25601
    UMLS 2011AA ObjectClass
    C1518544
    NCI Thesaurus Property
    C25275
    UMLS 2011AA Property
    C2745955
    Reason Treatment Ended (Intervention check one)
    Description

    Off Treatment Reason

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25638
    UMLS CUI-1
    C1518544
    NCI Thesaurus ObjectClass
    C25601
    UMLS CUI-2
    C0566251
    NCI Thesaurus Property
    C25365
    Patient withdrawal/refusal after beginning protocol therapy specify
    Description

    PatientBeginProtocolTherapyRefuseSpecify

    Data type

    text

    Alias
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C25320
    UMLS 2011AA Property
    C1507394
    NCI Thesaurus Property-2
    C49161
    UMLS 2011AA Property-2
    C1705116
    NCI Thesaurus Property-3
    C15368
    NCI Thesaurus Property-4
    C25431
    UMLS 2011AA Property-3
    C0439659
    NCI Thesaurus ValueDomain
    C25685
    UMLS 2011AA ValueDomain
    C1521902
    Patient withdrawal/refusal prior to beginning protocol therapy specify
    Description

    PatientPriorProtocolTherapyRefuseSpecify

    Data type

    text

    Alias
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C25320
    UMLS 2011AA Property
    C1507394
    NCI Thesaurus Property-2
    C49161
    UMLS 2011AA Property-2
    C1705116
    NCI Thesaurus Property-3
    C25629
    UMLS 2011AA Property-3
    C0332152
    NCI Thesaurus Property-4
    C15368
    NCI Thesaurus ValueDomain
    C25685
    UMLS 2011AA ValueDomain
    C1521902
    Adverse event/side effects/complications specify
    Description

    Off-TreatmentAdverseEventReasonSpecify

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25685
    UMLS 2011AA ValueDomain
    C1521902
    NCI Thesaurus Property
    C25638
    UMLS 2011AA Property
    C0392360
    NCI Thesaurus Property-2
    C41331
    UMLS 2011AA Property-2
    C0877248
    NCI Thesaurus ObjectClass
    C25601
    UMLS 2011AA ObjectClass
    C1518544
    Alternative Therapy, specify
    Description

    Off-treatmentAlternativeReasonSpecify

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25685
    UMLS 2011AA ValueDomain
    C1521902
    NCI Thesaurus ObjectClass
    C25601
    UMLS 2011AA ObjectClass
    C1518544
    NCI Thesaurus Property
    C25415
    UMLS 2011AA Property
    C1523987
    NCI Thesaurus Property-2
    C25365
    UMLS 2011AA Property-2
    C0678257
    Patient off-treatment for other complicating disease, Specify
    Description

    Off Treatment Reason, specify

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25685
    UMLS CUI-1
    C1518544
    NCI Thesaurus ObjectClass
    C25601
    UMLS CUI-2
    C0566251
    NCI Thesaurus Property
    C25365
    UMLS CUI-3
    C1521902
    NCI Thesaurus Property-2
    C25455
    Other specify
    Description

    Off Treatment Reason, specify

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25685
    UMLS CUI-1
    C1518544
    NCI Thesaurus ObjectClass
    C25601
    UMLS CUI-2
    C0566251
    NCI Thesaurus Property
    C25365
    UMLS CUI-3
    C1521902

    Similar models

    ALL ITEMS MUST BE COMPLETED

    1. StudyEvent: ACOSOG-Z4099 End of Intervention Form
      1. ALL ITEMS MUST BE COMPLETED
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Header Module
    ProtocolACOSOGIdentifierNumber
    Item
    Protocol Number
    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)
    C19712 (NCI Thesaurus Property-2)
    C1515944 (UMLS 2011AA Property-2)
    Patient Study ID
    Item
    Patient ID
    text
    C25337 (NCI Thesaurus ValueDomain)
    C2348585 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C25462 (NCI Thesaurus Property)
    C25364 (NCI Thesaurus Property-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 Number
    Item
    Institution Number
    text
    C25337 (NCI Thesaurus ValueDomain)
    C1301943 (UMLS CUI-1)
    C21541 (NCI Thesaurus ObjectClass)
    C0805701 (UMLS CUI-2)
    C25364 (NCI Thesaurus Property)
    Institution Name
    Item
    Institution
    text
    C25191 (NCI Thesaurus ValueDomain)
    C1301943 (UMLS CUI-1)
    C21541 (NCI Thesaurus ObjectClass)
    C21541 (NCI Thesaurus ValueDomain-2)
    C25364 (NCI Thesaurus Property)
    Data amended
    Item
    Are data amended (check one if data amended, please circle in red when using paper forms)
    boolean
    C38148 (NCI Thesaurus ValueDomain)
    C0680532 (UMLS CUI-1)
    C25474 (NCI Thesaurus ObjectClass)
    C25416 (NCI Thesaurus Property)
    Item Group
    Preregistration Screening Failure
    Treatment End Date
    Item
    Last Date (any modality of) protocol therapy was given (dd MMM yyyy date of surgery or last SBRT fraction on this study or date decision made not to initiate protocol treatment)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C1531784 (UMLS CUI-1)
    C15368 (NCI Thesaurus ObjectClass)
    C25275 (NCI Thesaurus Property)
    C25496 (NCI Thesaurus Property-2)
    OffTreatmentDate
    Item
    Off Treatment Date (dd MMM yyyy date decision was made to end active treatment or not to initiate protocol treatment)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C25601 (NCI Thesaurus ObjectClass)
    C1518544 (UMLS 2011AA ObjectClass)
    C25275 (NCI Thesaurus Property)
    C2745955 (UMLS 2011AA Property)
    Item
    Reason Treatment Ended (Intervention check one)
    text
    C25638 (NCI Thesaurus ValueDomain)
    C1518544 (UMLS CUI-1)
    C25601 (NCI Thesaurus ObjectClass)
    C0566251 (UMLS CUI-2)
    C25365 (NCI Thesaurus Property)
    Code List
    Reason Treatment Ended (Intervention check one)
    CL Item
    Treatment Completed Per Protocol Criteria (Treatment completed per protocol criteria)
    CL Item
    Patient Withdrawal Or Refusal After Beginning Protocol Therapy (Patient withdrawal/refusal after beginning protocol therapy)
    CL Item
    Patient Withdrawal Or Refusal Before Beginning Protocol Therapy (Patient withdrawal/refusal prior to beginning protocol therapy)
    CL Item
    Adverse Event/side Effects/complications (Adverse Event/Side Effects/Complications)
    CL Item
    Disease Progression, Relapse During Active Treatment (Disease progression, relapse during active treatment)
    CL Item
    Disease Progression Before Active Treatment (Disease Progression before active treatment)
    CL Item
    Alternative Therapy (Alternative therapy)
    CL Item
    Patient Off-treatment For Other Complicating Disease (Patient off-treatment for other complicating disease)
    CL Item
    Death On Study (Death on study)
    CL Item
    Other (Other)
    C17649 (NCI Thesaurus)
    C0205394 (UMLS 2011AA)
    PatientBeginProtocolTherapyRefuseSpecify
    Item
    Patient withdrawal/refusal after beginning protocol therapy specify
    text
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25320 (NCI Thesaurus Property)
    C1507394 (UMLS 2011AA Property)
    C49161 (NCI Thesaurus Property-2)
    C1705116 (UMLS 2011AA Property-2)
    C15368 (NCI Thesaurus Property-3)
    C25431 (NCI Thesaurus Property-4)
    C0439659 (UMLS 2011AA Property-3)
    C25685 (NCI Thesaurus ValueDomain)
    C1521902 (UMLS 2011AA ValueDomain)
    PatientPriorProtocolTherapyRefuseSpecify
    Item
    Patient withdrawal/refusal prior to beginning protocol therapy specify
    text
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25320 (NCI Thesaurus Property)
    C1507394 (UMLS 2011AA Property)
    C49161 (NCI Thesaurus Property-2)
    C1705116 (UMLS 2011AA Property-2)
    C25629 (NCI Thesaurus Property-3)
    C0332152 (UMLS 2011AA Property-3)
    C15368 (NCI Thesaurus Property-4)
    C25685 (NCI Thesaurus ValueDomain)
    C1521902 (UMLS 2011AA ValueDomain)
    Off-TreatmentAdverseEventReasonSpecify
    Item
    Adverse event/side effects/complications specify
    text
    C25685 (NCI Thesaurus ValueDomain)
    C1521902 (UMLS 2011AA ValueDomain)
    C25638 (NCI Thesaurus Property)
    C0392360 (UMLS 2011AA Property)
    C41331 (NCI Thesaurus Property-2)
    C0877248 (UMLS 2011AA Property-2)
    C25601 (NCI Thesaurus ObjectClass)
    C1518544 (UMLS 2011AA ObjectClass)
    Off-treatmentAlternativeReasonSpecify
    Item
    Alternative Therapy, specify
    text
    C25685 (NCI Thesaurus ValueDomain)
    C1521902 (UMLS 2011AA ValueDomain)
    C25601 (NCI Thesaurus ObjectClass)
    C1518544 (UMLS 2011AA ObjectClass)
    C25415 (NCI Thesaurus Property)
    C1523987 (UMLS 2011AA Property)
    C25365 (NCI Thesaurus Property-2)
    C0678257 (UMLS 2011AA Property-2)
    Off Treatment Reason, specify
    Item
    Patient off-treatment for other complicating disease, Specify
    text
    C25685 (NCI Thesaurus ValueDomain)
    C1518544 (UMLS CUI-1)
    C25601 (NCI Thesaurus ObjectClass)
    C0566251 (UMLS CUI-2)
    C25365 (NCI Thesaurus Property)
    C1521902 (UMLS CUI-3)
    C25455 (NCI Thesaurus Property-2)
    Off Treatment Reason, specify
    Item
    Other specify
    text
    C25685 (NCI Thesaurus ValueDomain)
    C1518544 (UMLS CUI-1)
    C25601 (NCI Thesaurus ObjectClass)
    C0566251 (UMLS CUI-2)
    C25365 (NCI Thesaurus Property)
    C1521902 (UMLS CUI-3)

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