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10919

Beschreibung

SOUTHWEST ONCOLOGY GROUP S0500 CTC SUBMISSION FORM NCT00382018 Treatment Decision Making Based on Blood Levels of Tumor Cells in Women With Metastatic Breast Cancer Receiving Chemotherapy Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=804A6A4D-69FB-2D51-E040-BB89AD4340B3

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=804A6A4D-69FB-2D51-E040-BB89AD4340B3

Stichworte

  1. 26.08.12 26.08.12 -
  2. 09.01.15 09.01.15 - Martin Dugas
  3. 12.06.15 12.06.15 -
Hochgeladen am

12. Juni 2015

DOI

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    SOUTHWEST ONCOLOGY GROUP S0500 CTC SUBMISSION FORM NCT00382018

    No Instruction available.

    1. StudyEvent: SOUTHWEST ONCOLOGY GROUP S0500 CTC SUBMISSION FORM
      1. No Instruction available.
    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
    CTC submission timepoint
    Beschreibung

    CirculatingTumorCellSpecimenTimepointSubmissionType

    Datentyp

    text

    Alias
    NCI Thesaurus ObjectClass
    C63797
    UMLS 2011AA ObjectClass
    C0027625
    NCI Thesaurus ObjectClass-2
    C19157
    UMLS 2011AA ObjectClass-2
    C0370003
    NCI Thesaurus Property
    C68568
    UMLS 2011AA Property
    C2348792
    NCI Thesaurus Property-2
    C25694
    UMLS 2011AA Property-2
    C1515022
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    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 (Participating Group:)
    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
    Group Name
    Beschreibung

    GroupName

    Datentyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS 2011AA ValueDomain
    C1547383
    NCI Thesaurus ObjectClass
    C17005
    UMLS 2011AA ObjectClass
    C1257890
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    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 (Instructions: 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 the top of the form.)
    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
    Blood sample
    Beschreibung

    Blood sample

    Was the blood sample drawn and submitted to Veridex for this timepoint
    Beschreibung

    CirculatingTumorCellSpecimenTimepointSubmissionInd-2

    Datentyp

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C63797
    UMLS 2011AA ObjectClass
    C0027625
    NCI Thesaurus ObjectClass-2
    C19157
    UMLS 2011AA ObjectClass-2
    C0370003
    NCI Thesaurus Property
    C68568
    UMLS 2011AA Property
    C2348792
    NCI Thesaurus Property-2
    C25694
    UMLS 2011AA Property-2
    C1515022
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    Date of blood sample collection (IF yes,)
    Beschreibung

    CirculatingTumorCellSpecimenCollectionDate

    Datentyp

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus Property
    C25453
    UMLS 2011AA Property
    C1516698
    NCI Thesaurus ObjectClass
    C63797
    UMLS 2011AA ObjectClass
    C0027625
    NCI Thesaurus ObjectClass-2
    C19157
    UMLS 2011AA ObjectClass-2
    C0370003
    Was this a repeat blood sample collection for this submission timepoint
    Beschreibung

    CirculatingTumorCellSpecimenRepeatCollectionInd-2

    Datentyp

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C63797
    UMLS 2011AA ObjectClass
    C0027625
    NCI Thesaurus ObjectClass-2
    C19157
    UMLS 2011AA ObjectClass-2
    C0370003
    NCI Thesaurus Property
    C25453
    UMLS 2011AA Property
    C1516698
    NCI Thesaurus Property-2
    C47886
    UMLS 2011AA Property-2
    C0205341
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    Will the patient remain on study for future CTC blood draws
    Beschreibung

    CirculatingTumorCellSpecimenOnStudyFutureCollectionInd-2

    Datentyp

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C63797
    UMLS 2011AA ObjectClass
    C0027625
    NCI Thesaurus ObjectClass-2
    C19157
    UMLS 2011AA ObjectClass-2
    C0370003
    NCI Thesaurus Property
    C67527
    UMLS 2011AA Property
    C0016884
    NCI Thesaurus Property-2
    C25453
    UMLS 2011AA Property-2
    C1516698
    NCI Thesaurus Property-3
    C73469
    UMLS 2011AA Property-3
    C2349977
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    Off-protocol treatment
    Beschreibung

    Off-protocol treatment

    Off treatment reason
    Beschreibung

    PersonCirculatingTumorCellCollectionOffTreatmentReason

    Datentyp

    text

    Alias
    NCI Thesaurus ObjectClass
    C25190
    UMLS 2011AA ObjectClass
    C0027361
    NCI Thesaurus Property
    C25601
    UMLS 2011AA Property
    C1518544
    NCI Thesaurus Property-2
    C25453
    UMLS 2011AA Property-2
    C1516698
    NCI Thesaurus Property-3
    C63797
    UMLS 2011AA Property-3
    C0027625
    NCI Thesaurus ValueDomain
    C25638
    UMLS 2011AA ValueDomain
    C0392360
    Other, specify
    Beschreibung

    PersonCirculatingTumorCellCollectionOffTreatmentSpecify

    Datentyp

    text

    Alias
    NCI Thesaurus ObjectClass
    C25190
    UMLS 2011AA ObjectClass
    C0027361
    NCI Thesaurus Property
    C25601
    UMLS 2011AA Property
    C1518544
    NCI Thesaurus Property-2
    C25453
    UMLS 2011AA Property-2
    C1516698
    NCI Thesaurus Property-3
    C63797
    UMLS 2011AA Property-3
    C0027625
    NCI Thesaurus ValueDomain
    C25685
    UMLS 2011AA ValueDomain
    C1521902
    Off treatment date (Date of completion, progression, death, or decision to discontinue CTC blood draws)
    Beschreibung

    PersonCirculatingTumorCellCollectionOffTreatmentDate

    Datentyp

    date

    Alias
    NCI Thesaurus ObjectClass
    C25190
    UMLS 2011AA ObjectClass
    C0027361
    NCI Thesaurus Property
    C25601
    UMLS 2011AA Property
    C1518544
    NCI Thesaurus Property-2
    C25453
    UMLS 2011AA Property-2
    C1516698
    NCI Thesaurus Property-3
    C63797
    UMLS 2011AA Property-3
    C0027625
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    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

    Ähnliche Modelle

    No Instruction available.

    1. StudyEvent: SOUTHWEST ONCOLOGY GROUP S0500 CTC SUBMISSION FORM
      1. No Instruction available.
    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)
    Item
    CTC submission timepoint
    text
    C63797 (NCI Thesaurus ObjectClass)
    C0027625 (UMLS 2011AA ObjectClass)
    C19157 (NCI Thesaurus ObjectClass-2)
    C0370003 (UMLS 2011AA ObjectClass-2)
    C68568 (NCI Thesaurus Property)
    C2348792 (UMLS 2011AA Property)
    C25694 (NCI Thesaurus Property-2)
    C1515022 (UMLS 2011AA Property-2)
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    Code List
    CTC submission timepoint
    CL Item
    Day 169 (Day 169)
    CL Item
    Day 22 (Day 22)
    CL Item
    Day 253 (Day 253)
    CL Item
    Day 50/57 (Day 50/57)
    CL Item
    Day 85 (Day 85)
    CL Item
    Pretreatment (Pretreatment)
    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 (Participating Group:)
    text
    C25191 (NCI Thesaurus ValueDomain)
    C2826892 (UMLS CUI-1)
    C25364 (NCI Thesaurus Property)
    C17089 (NCI Thesaurus ObjectClass)
    C25644 (NCI Thesaurus ObjectClass-2)
    GroupName
    Item
    Group Name
    text
    C25191 (NCI Thesaurus ValueDomain)
    C1547383 (UMLS 2011AA ValueDomain)
    C17005 (NCI Thesaurus ObjectClass)
    C1257890 (UMLS 2011AA ObjectClass)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA 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 (Instructions: 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 the top of the form.)
    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
    Blood sample
    CirculatingTumorCellSpecimenTimepointSubmissionInd-2
    Item
    Was the blood sample drawn and submitted to Veridex for this timepoint
    boolean
    C63797 (NCI Thesaurus ObjectClass)
    C0027625 (UMLS 2011AA ObjectClass)
    C19157 (NCI Thesaurus ObjectClass-2)
    C0370003 (UMLS 2011AA ObjectClass-2)
    C68568 (NCI Thesaurus Property)
    C2348792 (UMLS 2011AA Property)
    C25694 (NCI Thesaurus Property-2)
    C1515022 (UMLS 2011AA Property-2)
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    CirculatingTumorCellSpecimenCollectionDate
    Item
    Date of blood sample collection (IF yes,)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C25453 (NCI Thesaurus Property)
    C1516698 (UMLS 2011AA Property)
    C63797 (NCI Thesaurus ObjectClass)
    C0027625 (UMLS 2011AA ObjectClass)
    C19157 (NCI Thesaurus ObjectClass-2)
    C0370003 (UMLS 2011AA ObjectClass-2)
    CirculatingTumorCellSpecimenRepeatCollectionInd-2
    Item
    Was this a repeat blood sample collection for this submission timepoint
    boolean
    C63797 (NCI Thesaurus ObjectClass)
    C0027625 (UMLS 2011AA ObjectClass)
    C19157 (NCI Thesaurus ObjectClass-2)
    C0370003 (UMLS 2011AA ObjectClass-2)
    C25453 (NCI Thesaurus Property)
    C1516698 (UMLS 2011AA Property)
    C47886 (NCI Thesaurus Property-2)
    C0205341 (UMLS 2011AA Property-2)
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    CirculatingTumorCellSpecimenOnStudyFutureCollectionInd-2
    Item
    Will the patient remain on study for future CTC blood draws
    boolean
    C63797 (NCI Thesaurus ObjectClass)
    C0027625 (UMLS 2011AA ObjectClass)
    C19157 (NCI Thesaurus ObjectClass-2)
    C0370003 (UMLS 2011AA ObjectClass-2)
    C67527 (NCI Thesaurus Property)
    C0016884 (UMLS 2011AA Property)
    C25453 (NCI Thesaurus Property-2)
    C1516698 (UMLS 2011AA Property-2)
    C73469 (NCI Thesaurus Property-3)
    C2349977 (UMLS 2011AA Property-3)
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    Item Group
    Off-protocol treatment
    Item
    Off treatment reason
    text
    C25190 (NCI Thesaurus ObjectClass)
    C0027361 (UMLS 2011AA ObjectClass)
    C25601 (NCI Thesaurus Property)
    C1518544 (UMLS 2011AA Property)
    C25453 (NCI Thesaurus Property-2)
    C1516698 (UMLS 2011AA Property-2)
    C63797 (NCI Thesaurus Property-3)
    C0027625 (UMLS 2011AA Property-3)
    C25638 (NCI Thesaurus ValueDomain)
    C0392360 (UMLS 2011AA ValueDomain)
    Code List
    Off treatment reason
    CL Item
    Day 253 Blood Draw Completed Per Protocol Criteria (Day 253 blood draw completed per protocol criteria)
    CL Item
    Death (Death)
    C28554 (NCI Thesaurus)
    C0011065 (UMLS 2011AA)
    CL Item
    Other (Other)
    CL Item
    Patient Withdrew Consent For All Future Blood Draws (Patient withdrew consent for all future blood draws)
    CL Item
    Progression Or Relapse (Progression or relapse)
    PersonCirculatingTumorCellCollectionOffTreatmentSpecify
    Item
    Other, specify
    text
    C25190 (NCI Thesaurus ObjectClass)
    C0027361 (UMLS 2011AA ObjectClass)
    C25601 (NCI Thesaurus Property)
    C1518544 (UMLS 2011AA Property)
    C25453 (NCI Thesaurus Property-2)
    C1516698 (UMLS 2011AA Property-2)
    C63797 (NCI Thesaurus Property-3)
    C0027625 (UMLS 2011AA Property-3)
    C25685 (NCI Thesaurus ValueDomain)
    C1521902 (UMLS 2011AA ValueDomain)
    PersonCirculatingTumorCellCollectionOffTreatmentDate
    Item
    Off treatment date (Date of completion, progression, death, or decision to discontinue CTC blood draws)
    date
    C25190 (NCI Thesaurus ObjectClass)
    C0027361 (UMLS 2011AA ObjectClass)
    C25601 (NCI Thesaurus Property)
    C1518544 (UMLS 2011AA Property)
    C25453 (NCI Thesaurus Property-2)
    C1516698 (UMLS 2011AA Property-2)
    C63797 (NCI Thesaurus Property-3)
    C0027625 (UMLS 2011AA Property-3)
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    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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