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ID

11665

Description

SOUTHWEST ONCOLOGY GROUP Previously Untreated Acute Promyelocytic Leukemia Prestudy Form (S0521) 2412866v1.0 Combination Chemotherapy With or Without Gemtuzumab Followed By Tretinoin, Mercaptopurine, and Methotrexate or Observation in Treating Patients With Acute Promyelocytic Leukemia Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=01FDEB64-5CFB-0063-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=01FDEB64-5CFB-0063-E044-0003BA3F9857

Keywords

  1. 9/19/12 9/19/12 -
  2. 1/9/15 1/9/15 - Martin Dugas
  3. 7/25/15 7/25/15 - Martin Dugas
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July 25, 2015

DOI

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License

Creative Commons BY-NC 3.0 Legacy

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    Prestudy Form Acute Promyelocytic Leukemia NCT00492856

    No Instruction available.

    1. StudyEvent: SOUTHWEST ONCOLOGY GROUP Previously Untreated Acute Promyelocytic Leukemia Prestudy Form (S0521)
      1. No Instruction available.
    Header
    Description

    Header

    SWOG Patient ID
    Description

    Trial subject ID SWOG

    Data type

    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.
    Description

    Protocol ID SWOG

    Data type

    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
    Description

    Registration Number

    Data type

    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)
    Description

    Patient Initials

    Data type

    text

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

    Institution Name

    Data type

    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:)
    Description

    Investigator Name

    Data type

    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
    Description

    Participating Group

    Data type

    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.
    Description

    Study Number Participating Group

    Data type

    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.)
    Description

    Trial subject ID Participating Group

    Data type

    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 Characteristics
    Description

    Patient Characteristics

    Performance Status
    Description

    ECOG Performance Status

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25664
    UMLS CUI-1
    C1520224
    NCI Thesaurus Property
    C25367
    NCI Thesaurus ValueDomain-2
    C25491
    NCI Thesaurus ObjectClass
    C20641
    Risk classification at first registration
    Description

    PatientFirstProtocolRegistrationDiseaseRiskCategory

    Data type

    text

    Alias
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25320
    NCI Thesaurus Property-2
    C25646
    NCI Thesaurus Property-3
    C25509
    NCI Thesaurus ValueDomain
    C25372
    NCI Thesaurus ValueDomain-2
    C2991
    NCI Thesaurus ValueDomain-3
    C17102
    UMLS CUI-1
    C0086930
    Specimen for RT-PCR (Pretreatment)
    Description

    RT-PCRSpecimenCollectionSource

    Data type

    text

    Alias
    NCI Thesaurus ObjectClass
    C18136
    UMLS 2011AA ObjectClass
    C0599161
    NCI Thesaurus Property
    C25453
    UMLS 2011AA Property
    C1516698
    NCI Thesaurus ValueDomain
    C25683
    UMLS 2011AA ValueDomain
    C0449416
    NCI Thesaurus ObjectClass-2
    C19157
    UMLS 2011AA ObjectClass-2
    C0370003
    Date of marrow specimen collection
    Description

    BoneMarrowSpecimenCollectionDate

    Data type

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ObjectClass
    C12431
    UMLS 2011AA ObjectClass
    C0005953
    NCI Thesaurus Property
    C25453
    UMLS 2011AA Property
    C1516698
    NCI Thesaurus ObjectClass-2
    C19157
    UMLS 2011AA ObjectClass-2
    C0370003
    Date of blood specimen collection
    Description

    BloodSpecimenCollectionDate

    Data type

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ObjectClass
    C12434
    UMLS 2011AA ObjectClass
    C0229664
    NCI Thesaurus ObjectClass-2
    C19157
    UMLS 2011AA ObjectClass-2
    C0370003
    NCI Thesaurus Property
    C25452
    Did the patient receive ATRA prior to registration
    Description

    ATRAAgentPriorClinicalTrialRegistrationAdministeredInd-2

    Data type

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C1708
    UMLS 2011AA ObjectClass
    C0450442
    NCI Thesaurus ObjectClass-2
    C900
    UMLS 2011AA ObjectClass-2
    C0040845
    NCI Thesaurus Property
    C25646
    UMLS 2011AA Property
    C1514821
    NCI Thesaurus Property-2
    C25629
    UMLS 2011AA Property-2
    C0332152
    NCI Thesaurus Property-3
    C15207
    NCI Thesaurus Property-4
    C25382
    UMLS 2011AA Property-3
    C1521801
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    Date ATRA first given
    Description

    ATRAAgentPriorClinicalTrialRegistrationAdministeredBeginDate

    Data type

    date

    Alias
    NCI Thesaurus ObjectClass
    C1708
    UMLS 2011AA ObjectClass
    C0450442
    NCI Thesaurus ObjectClass-2
    C900
    UMLS 2011AA ObjectClass-2
    C0040845
    NCI Thesaurus Property
    C25646
    UMLS 2011AA Property
    C1514821
    NCI Thesaurus Property-2
    C25629
    UMLS 2011AA Property-2
    C0332152
    NCI Thesaurus Property-3
    C15207
    NCI Thesaurus Property-4
    C25382
    UMLS 2011AA Property-3
    C1521801
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ValueDomain-2
    C25431
    UMLS 2011AA ValueDomain-2
    C0439659
    Number of days of ATRA before registration
    Description

    ATRAAgentPriorClinicalTrialRegistrationAdministeredDayCount

    Data type

    float

    Alias
    NCI Thesaurus ObjectClass
    C1708
    UMLS 2011AA ObjectClass
    C0450442
    NCI Thesaurus ObjectClass-2
    C900
    UMLS 2011AA ObjectClass-2
    C0040845
    NCI Thesaurus Property
    C25646
    UMLS 2011AA Property
    C1514821
    NCI Thesaurus Property-2
    C25629
    UMLS 2011AA Property-2
    C0332152
    NCI Thesaurus Property-3
    C15207
    NCI Thesaurus Property-4
    C25382
    UMLS 2011AA Property-3
    C1521801
    NCI Thesaurus ValueDomain
    C25301
    UMLS 2011AA ValueDomain
    C0439228
    NCI Thesaurus ValueDomain-2
    C25463
    UMLS 2011AA ValueDomain-2
    C0750480
    Maximum dose of ATRA before registration
    Description

    ATRAAgentPriorClinicalTrialRegistrationAdministeredMaximumDose

    Data type

    float

    Measurement units
    • mg/m^2/day
    Alias
    NCI Thesaurus ObjectClass
    C1708
    NCI Thesaurus ObjectClass-2
    C900
    NCI Thesaurus Property
    C25646
    NCI Thesaurus Property-2
    C25629
    NCI Thesaurus Property-3
    C15207
    NCI Thesaurus Property-4
    C25382
    NCI Thesaurus ValueDomain
    C25564
    NCI Thesaurus ValueDomain-2
    C25488
    UMLS CUI-1
    C0040845
    UMLS CUI-2
    C0806909
    UMLS CUI-3
    C0178602
    mg/m^2/day
    Is patient a woman of childbearing potential (indicator NO for males)
    Description

    FemalePatientPotentialPregnancyInd-2

    Data type

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus ObjectClass-2
    C16576
    NCI Thesaurus Property
    C25742
    NCI Metathesaurus Property
    C0237399
    NCI Thesaurus ValueDomain
    C38147
    UMLS CUI-1
    C3831118
    Has a negative pregnancy test been performed
    Description

    PatientNegativePregnancyTestInd-2

    Data type

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38147
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25247
    NCI Metathesaurus Property
    C0032976
    UMLS CUI-1
    C0427780
    Date of pregnancy test
    Description

    PatientMostRecentPregnancyTestDate

    Data type

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    NCI Thesaurus ObjectClass
    C16960
    NCI Metathesaurus Property
    C0032976
    NCI Thesaurus Property
    C25577
    UMLS CUI-1
    C0032976
    UMLS CUI-2
    C0011008
    Patient And Disease Description
    Description

    Patient And Disease Description

    Height
    Description

    Height

    Data type

    float

    Measurement units
    • cm
    Alias
    NCI Thesaurus ValueDomain
    C25209
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25347
    UMLS CUI-1
    C0005890
    cm
    Date of Initial Pathologic Diagnosis
    Description

    CancerInitialDiagnosisDate

    Data type

    date

    Alias
    NCI Thesaurus ObjectClass
    C9305
    NCI Thesaurus Property
    C25509
    NCI Thesaurus Property-2
    C15220
    NCI Thesaurus ValueDomain
    C25164
    NCI Thesaurus ValueDomain-2
    C25367
    UMLS CUI-1
    C0006826
    UMLS CUI-2
    C2316983
    Patient Disseminated Intravascular Coagulation Personal Medical History Indicator
    Description

    PatientDisseminatedIntravascularCoagulationPersonalMedicalHistoryIndicator

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25180
    UMLS 2011AA ValueDomain
    C1522602
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C2992
    UMLS 2011AA Property
    C0012739
    NCI Thesaurus Property-2
    C18772
    UMLS 2011AA Property-2
    C0262926
    Current Laboratory Values
    Description

    Current Laboratory Values

    Date Hematology (Blood) Sample Obtained
    Description

    HematologyLabCollectedDate

    Data type

    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 ValueDomain-2
    C25452
    Time hematology sample obtained
    Description

    HematologySpecimenCollectedTime

    Data type

    time

    Alias
    NCI Thesaurus ObjectClass
    C16673
    UMLS 2011AA ObjectClass
    C0018943
    NCI Thesaurus ValueDomain
    C25207
    UMLS 2011AA ValueDomain
    C0040223
    NCI Thesaurus ObjectClass-2
    C19157
    UMLS 2011AA ObjectClass-2
    C0370003
    NCI Thesaurus Property
    C25452
    Hemoglobin
    Description

    Hemoglobin

    Data type

    float

    Alias
    NCI Thesaurus Property
    C16676
    UMLS CUI-1
    C0019046
    NCI Thesaurus Property-2
    C20200
    NCI Thesaurus ObjectClass
    C25294
    NCI Thesaurus ValueDomain
    C25712
    Peripheral Platelet Count
    Description

    Platelets

    Data type

    float

    Measurement units
    • 1000/uL
    Alias
    NCI Thesaurus Property
    C20200
    UMLS CUI-1
    C0005821
    NCI Thesaurus Property-2
    C12520
    NCI Thesaurus ObjectClass
    C25294
    NCI Thesaurus ValueDomain
    C25712
    1000/uL
    Peripheral Blasts
    Description

    LaboratoryProcedureBlastCellOutcomePercentageValue

    Data type

    float

    Measurement units
    • %
    Alias
    NCI Thesaurus ObjectClass
    C25294
    NCI Thesaurus Property
    C20200
    NCI Thesaurus Property-2
    C12918
    NCI Thesaurus ValueDomain
    C25613
    NCI Thesaurus ValueDomain-2
    C25712
    UMLS CUI-1
    C0368761
    %
    Peripheral WBC Count
    Description

    Leukocytes (WBC)

    Data type

    float

    Measurement units
    • 1000/uL
    Alias
    NCI Thesaurus ObjectClass
    C25294
    UMLS CUI-1
    C0023508
    NCI Thesaurus Property
    C12529
    NCI Thesaurus Property-2
    C20200
    NCI Thesaurus ValueDomain
    C25712
    NCI Thesaurus ValueDomain-2
    C38024
    1000/uL
    Peripheral Promyelocytes
    Description

    LaboratoryProcedurePromyelocyteResultPercentageValue

    Data type

    float

    Measurement units
    • %
    Alias
    NCI Thesaurus ObjectClass
    C25294
    NCI Thesaurus Property
    C20200
    NCI Thesaurus Property-2
    C13114
    NCI Thesaurus ValueDomain
    C25613
    NCI Thesaurus ValueDomain-2
    C25712
    UMLS CUI-1
    C0455279
    %
    Peripheral Neutrophils (%)
    Description

    Neutrophil percentage

    Data type

    float

    Measurement units
    • %
    Alias
    NCI Thesaurus ObjectClass
    C25294
    UMLS CUI-1
    C1171400
    NCI Thesaurus Property
    C12533
    NCI Thesaurus Property-2
    C20200
    NCI Thesaurus ValueDomain
    C25613
    NCI Thesaurus ValueDomain-2
    C25712
    %
    Bone Marrow Biopsy Date
    Description

    BoneMarrowBiopsyDate

    Data type

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ValueDomain-2
    C25367
    NCI Thesaurus Property
    C15189
    UMLS 2011AA Property
    C0005558
    NCI Thesaurus ObjectClass
    C12431
    UMLS 2011AA ObjectClass
    C0005953
    Marrow Blasts (%)
    Description

    Blasts, Bone Marrow

    Data type

    float

    Measurement units
    • %
    Alias
    NCI Thesaurus ObjectClass
    C25294
    UMLS CUI-1
    C1982687
    NCI Thesaurus Property
    C12431
    NCI Thesaurus Property-2
    C20200
    NCI Thesaurus Property-3
    C12918
    NCI Thesaurus ValueDomain
    C25613
    NCI Thesaurus ValueDomain-2
    C25712
    %
    Marrow Cellularity (%)
    Description

    Marrow Cellularity (%)

    Data type

    float

    Measurement units
    • %
    Alias
    NCI Thesaurus ObjectClass
    C25294
    NCI Thesaurus Property
    C12431
    NCI Thesaurus Property-2
    C20200
    NCI Thesaurus Property-3
    C37923
    NCI Thesaurus ValueDomain
    C25613
    NCI Thesaurus ValueDomain-2
    C25712
    UMLS CUI-1
    C1561532
    %
    Marrow Promyelocytes (%)
    Description

    LaboratoryProcedureBoneMarrowPromyelocyteResultPercentageValue

    Data type

    float

    Measurement units
    • %
    Alias
    NCI Thesaurus ObjectClass
    C25294
    NCI Thesaurus Property
    C12431
    NCI Thesaurus Property-2
    C20200
    NCI Thesaurus Property-3
    C13114
    NCI Thesaurus ValueDomain
    C25613
    NCI Thesaurus ValueDomain-2
    C25712
    UMLS CUI-1
    C0005953
    UMLS CUI-2
    C0033416
    %
    Marrow Cellularity Status
    Description

    LaboratoryProcedureBoneMarrowCellularityOutcomeStatus

    Data type

    text

    Alias
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus Property
    C12431
    UMLS 2011AA Property
    C0005953
    NCI Thesaurus Property-2
    C20200
    UMLS 2011AA Property-2
    C1274040
    NCI Thesaurus Property-3
    C37923
    UMLS 2011AA Property-3
    C1516377
    NCI Thesaurus ValueDomain
    C25688
    UMLS 2011AA ValueDomain
    C0449438
    Date of Examination for Extramedullary Disease
    Description

    PatientExtramedullaryDiseaseAssessmentDate

    Data type

    date

    Alias
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C20989
    UMLS 2011AA Property
    C0031809
    NCI Thesaurus Property-2
    C2991
    UMLS 2011AA Property-2
    C0012634
    NCI Thesaurus Property-3
    C25503
    UMLS 2011AA Property-3
    C1517060
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    Extramedullary Disease Involvement
    Description

    DiseaseExtramedullaryInvolvementSite

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C13717
    UMLS 2011AA ValueDomain
    C1515974
    NCI Thesaurus ObjectClass
    C2991
    UMLS 2011AA ObjectClass
    C0012634
    NCI Thesaurus Property
    C25548
    UMLS 2011AA Property
    C1314939
    NCI Thesaurus Property-2
    C25503
    UMLS 2011AA Property-2
    C1517060
    Other, specify
    Description

    DiseaseExtramedullaryInvolvementOtherSite

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C13717
    UMLS 2011AA ValueDomain
    C1515974
    NCI Thesaurus ObjectClass
    C2991
    UMLS 2011AA ObjectClass
    C0012634
    NCI Thesaurus Property
    C25548
    UMLS 2011AA Property
    C1314939
    NCI Thesaurus Property-2
    C25503
    UMLS 2011AA Property-2
    C1517060
    Comments
    Description

    Comments

    Comments
    Description

    Research Comments

    Data type

    text

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

    Similar models

    No Instruction available.

    1. StudyEvent: SOUTHWEST ONCOLOGY GROUP Previously Untreated Acute Promyelocytic Leukemia Prestudy Form (S0521)
      1. No Instruction available.
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    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 (Participating Group:)
    text
    C25191 (NCI Thesaurus ValueDomain)
    C2826892 (UMLS CUI-1)
    C25364 (NCI Thesaurus Property)
    C17089 (NCI Thesaurus ObjectClass)
    C25644 (NCI Thesaurus ObjectClass-2)
    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)
    Code List
    Participating Group Name
    CL Item
    American College Of Surgeons Oncology Group (ACOSOG)
    C19712 (NCI Thesaurus)
    C1515944 (UMLS 2011AA)
    CL Item
    American College Of Radiology Oncologic Imaging Network (ACRIN)
    CL Item
    Aids-associated Malignancies Clinical Trials Consortium (AMC)
    CL Item
    Cancer And Leukemia Group B (CALGB)
    C25442 (NCI Thesaurus)
    C1516238 (UMLS 2011AA)
    CL Item
    Children's Oncology Group (COG)
    C39353 (NCI Thesaurus)
    C1516477 (UMLS 2011AA)
    CL Item
    Eastern Cooperative Oncology Group (ECOG)
    C25491 (NCI Thesaurus)
    C1512162 (UMLS 2011AA)
    CL Item
    European Organization For Research And Treatment Of Cancer (EORTC)
    C19741 (NCI Thesaurus)
    C1516985 (UMLS 2011AA)
    CL Item
    Gynecologic Oncology Group (GOG)
    C25521 (NCI Thesaurus)
    C1512288 (UMLS 2011AA)
    CL Item
    International Breast Cancer Study Group (IBCSG)
    C25530 (NCI Thesaurus)
    C1512890 (UMLS 2011AA)
    CL Item
    North American Brain Tumor Consortium (NABTC)
    C37995 (NCI Thesaurus)
    C1518418 (UMLS 2011AA)
    CL Item
    Nabtt Brain Tumor Consortium (NABTT)
    CL Item
    North Central Cancer Treatment Group (NCCTG)
    C25581 (NCI Thesaurus)
    C1518419 (UMLS 2011AA)
    CL Item
    National Cancer Institute Of Canada Clinical Trials Group (NCIC)
    C39467 (NCI Thesaurus)
    C1513885 (UMLS 2011AA)
    CL Item
    National Surgical Adjuvant Breast And Bowel Project (NSABP)
    C15818 (NCI Thesaurus)
    C1513905 (UMLS 2011AA)
    CL Item
    Radiation Therapy Oncology Group (RTOG)
    C19778 (NCI Thesaurus)
    C1514695 (UMLS 2011AA)
    CL Item
    Southwest Oncology Group (SWOG)
    C25699 (NCI Thesaurus)
    C1519429 (UMLS 2011AA)
    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
    Patient Characteristics
    Item
    Performance Status
    text
    C25664 (NCI Thesaurus ValueDomain)
    C1520224 (UMLS CUI-1)
    C25367 (NCI Thesaurus Property)
    C25491 (NCI Thesaurus ValueDomain-2)
    C20641 (NCI Thesaurus ObjectClass)
    Code List
    Performance Status
    CL Item
    Fully Active, Able To Carry On All Pre-disease Performance Without Restriction. (0)
    CL Item
    Restricted In Physically Strenuous Activity But Ambulatory And Able To Carry Out Work Of A Light Or Sedentary Nature, E.g., Light Housework, Office Work. (1)
    CL Item
    Ambulatory And Capable Of All Selfcare But Unable To Carry Out Any Work Activities. Up And About More Than 50% Of Waking Hours. (2)
    CL Item
    Capable Of Only Limited Selfcare, Confined To Bed Or Chair More Than 50% Of Waking Hours. (3)
    CL Item
    Completely Disabled. Cannot Carry On Any Selfcare. Totally Confined To Bed Or Chair. (4)
    CL Item
    Dead (5)
    Item
    Risk classification at first registration
    text
    C16960 (NCI Thesaurus ObjectClass)
    C25320 (NCI Thesaurus Property)
    C25646 (NCI Thesaurus Property-2)
    C25509 (NCI Thesaurus Property-3)
    C25372 (NCI Thesaurus ValueDomain)
    C2991 (NCI Thesaurus ValueDomain-2)
    C17102 (NCI Thesaurus ValueDomain-3)
    C0086930 (UMLS CUI-1)
    Code List
    Risk classification at first registration
    CL Item
    Intermediate Risk (intermediate)
    C3640764 (UMLS CUI-1)
    CL Item
    Low Risk (low)
    C3538919 (UMLS CUI-1)
    Item
    Specimen for RT-PCR (Pretreatment)
    text
    C18136 (NCI Thesaurus ObjectClass)
    C0599161 (UMLS 2011AA ObjectClass)
    C25453 (NCI Thesaurus Property)
    C1516698 (UMLS 2011AA Property)
    C25683 (NCI Thesaurus ValueDomain)
    C0449416 (UMLS 2011AA ValueDomain)
    C19157 (NCI Thesaurus ObjectClass-2)
    C0370003 (UMLS 2011AA ObjectClass-2)
    Code List
    Specimen for RT-PCR (Pretreatment)
    CL Item
    Bone Marrow (bone marrow)
    C12431 (NCI Thesaurus)
    C0005953 (UMLS 2011AA)
    CL Item
    Peripheral Blood (peripheral blood)
    C0229664 (NCI Metathesaurus)
    BoneMarrowSpecimenCollectionDate
    Item
    Date of marrow specimen collection
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C12431 (NCI Thesaurus ObjectClass)
    C0005953 (UMLS 2011AA ObjectClass)
    C25453 (NCI Thesaurus Property)
    C1516698 (UMLS 2011AA Property)
    C19157 (NCI Thesaurus ObjectClass-2)
    C0370003 (UMLS 2011AA ObjectClass-2)
    BloodSpecimenCollectionDate
    Item
    Date of blood specimen collection
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C12434 (NCI Thesaurus ObjectClass)
    C0229664 (UMLS 2011AA ObjectClass)
    C19157 (NCI Thesaurus ObjectClass-2)
    C0370003 (UMLS 2011AA ObjectClass-2)
    C25452 (NCI Thesaurus Property)
    ATRAAgentPriorClinicalTrialRegistrationAdministeredInd-2
    Item
    Did the patient receive ATRA prior to registration
    boolean
    C1708 (NCI Thesaurus ObjectClass)
    C0450442 (UMLS 2011AA ObjectClass)
    C900 (NCI Thesaurus ObjectClass-2)
    C0040845 (UMLS 2011AA ObjectClass-2)
    C25646 (NCI Thesaurus Property)
    C1514821 (UMLS 2011AA Property)
    C25629 (NCI Thesaurus Property-2)
    C0332152 (UMLS 2011AA Property-2)
    C15207 (NCI Thesaurus Property-3)
    C25382 (NCI Thesaurus Property-4)
    C1521801 (UMLS 2011AA Property-3)
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    ATRAAgentPriorClinicalTrialRegistrationAdministeredBeginDate
    Item
    Date ATRA first given
    date
    C1708 (NCI Thesaurus ObjectClass)
    C0450442 (UMLS 2011AA ObjectClass)
    C900 (NCI Thesaurus ObjectClass-2)
    C0040845 (UMLS 2011AA ObjectClass-2)
    C25646 (NCI Thesaurus Property)
    C1514821 (UMLS 2011AA Property)
    C25629 (NCI Thesaurus Property-2)
    C0332152 (UMLS 2011AA Property-2)
    C15207 (NCI Thesaurus Property-3)
    C25382 (NCI Thesaurus Property-4)
    C1521801 (UMLS 2011AA Property-3)
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C25431 (NCI Thesaurus ValueDomain-2)
    C0439659 (UMLS 2011AA ValueDomain-2)
    ATRAAgentPriorClinicalTrialRegistrationAdministeredDayCount
    Item
    Number of days of ATRA before registration
    float
    C1708 (NCI Thesaurus ObjectClass)
    C0450442 (UMLS 2011AA ObjectClass)
    C900 (NCI Thesaurus ObjectClass-2)
    C0040845 (UMLS 2011AA ObjectClass-2)
    C25646 (NCI Thesaurus Property)
    C1514821 (UMLS 2011AA Property)
    C25629 (NCI Thesaurus Property-2)
    C0332152 (UMLS 2011AA Property-2)
    C15207 (NCI Thesaurus Property-3)
    C25382 (NCI Thesaurus Property-4)
    C1521801 (UMLS 2011AA Property-3)
    C25301 (NCI Thesaurus ValueDomain)
    C0439228 (UMLS 2011AA ValueDomain)
    C25463 (NCI Thesaurus ValueDomain-2)
    C0750480 (UMLS 2011AA ValueDomain-2)
    Maximum ATRA dose
    Item
    Maximum dose of ATRA before registration
    float
    C1708 (NCI Thesaurus ObjectClass)
    C900 (NCI Thesaurus ObjectClass-2)
    C25646 (NCI Thesaurus Property)
    C25629 (NCI Thesaurus Property-2)
    C15207 (NCI Thesaurus Property-3)
    C25382 (NCI Thesaurus Property-4)
    C25564 (NCI Thesaurus ValueDomain)
    C25488 (NCI Thesaurus ValueDomain-2)
    C0040845 (UMLS CUI-1)
    C0806909 (UMLS CUI-2)
    C0178602 (UMLS CUI-3)
    Woman with childbearing potential
    Item
    Is patient a woman of childbearing potential (indicator NO for males)
    boolean
    C16960 (NCI Thesaurus ObjectClass)
    C16576 (NCI Thesaurus ObjectClass-2)
    C25742 (NCI Thesaurus Property)
    C0237399 (NCI Metathesaurus Property)
    C38147 (NCI Thesaurus ValueDomain)
    C3831118 (UMLS CUI-1)
    Pregnancy test negative
    Item
    Has a negative pregnancy test been performed
    boolean
    C38147 (NCI Thesaurus ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C25247 (NCI Thesaurus Property)
    C0032976 (NCI Metathesaurus Property)
    C0427780 (UMLS CUI-1)
    Pregnancy test date
    Item
    Date of pregnancy test
    date
    C25164 (NCI Thesaurus ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0032976 (NCI Metathesaurus Property)
    C25577 (NCI Thesaurus Property)
    C0032976 (UMLS CUI-1)
    C0011008 (UMLS CUI-2)
    Item Group
    Patient And Disease Description
    Height
    Item
    Height
    float
    C25209 (NCI Thesaurus ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C25347 (NCI Thesaurus Property)
    C0005890 (UMLS CUI-1)
    Tumor diagnosis date
    Item
    Date of Initial Pathologic Diagnosis
    date
    C9305 (NCI Thesaurus ObjectClass)
    C25509 (NCI Thesaurus Property)
    C15220 (NCI Thesaurus Property-2)
    C25164 (NCI Thesaurus ValueDomain)
    C25367 (NCI Thesaurus ValueDomain-2)
    C0006826 (UMLS CUI-1)
    C2316983 (UMLS CUI-2)
    Item
    Patient Disseminated Intravascular Coagulation Personal Medical History Indicator
    text
    C25180 (NCI Thesaurus ValueDomain)
    C1522602 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C2992 (NCI Thesaurus Property)
    C0012739 (UMLS 2011AA Property)
    C18772 (NCI Thesaurus Property-2)
    C0262926 (UMLS 2011AA Property-2)
    Code List
    Patient Disseminated Intravascular Coagulation Personal Medical History Indicator
    CL Item
    No: C0028423 (No)
    C0028423 (NCI Metathesaurus)
    CL Item
    Yes, With Bleeding (Yes, with bleeding)
    CL Item
    Yes, Without Bleeding (Yes, without bleeding)
    Item Group
    Current Laboratory Values
    HematologyLabCollectedDate
    Item
    Date Hematology (Blood) Sample Obtained
    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)
    C25452 (NCI Thesaurus ValueDomain-2)
    HematologySpecimenCollectedTime
    Item
    Time hematology sample obtained
    time
    C16673 (NCI Thesaurus ObjectClass)
    C0018943 (UMLS 2011AA ObjectClass)
    C25207 (NCI Thesaurus ValueDomain)
    C0040223 (UMLS 2011AA ValueDomain)
    C19157 (NCI Thesaurus ObjectClass-2)
    C0370003 (UMLS 2011AA ObjectClass-2)
    C25452 (NCI Thesaurus Property)
    Hemoglobin
    Item
    Hemoglobin
    float
    C16676 (NCI Thesaurus Property)
    C0019046 (UMLS CUI-1)
    C20200 (NCI Thesaurus Property-2)
    C25294 (NCI Thesaurus ObjectClass)
    C25712 (NCI Thesaurus ValueDomain)
    Platelets
    Item
    Peripheral Platelet Count
    float
    C20200 (NCI Thesaurus Property)
    C0005821 (UMLS CUI-1)
    C12520 (NCI Thesaurus Property-2)
    C25294 (NCI Thesaurus ObjectClass)
    C25712 (NCI Thesaurus ValueDomain)
    Blasts
    Item
    Peripheral Blasts
    float
    C25294 (NCI Thesaurus ObjectClass)
    C20200 (NCI Thesaurus Property)
    C12918 (NCI Thesaurus Property-2)
    C25613 (NCI Thesaurus ValueDomain)
    C25712 (NCI Thesaurus ValueDomain-2)
    C0368761 (UMLS CUI-1)
    Leukocytes (WBC)
    Item
    Peripheral WBC Count
    float
    C25294 (NCI Thesaurus ObjectClass)
    C0023508 (UMLS CUI-1)
    C12529 (NCI Thesaurus Property)
    C20200 (NCI Thesaurus Property-2)
    C25712 (NCI Thesaurus ValueDomain)
    C38024 (NCI Thesaurus ValueDomain-2)
    Promyelocytes
    Item
    Peripheral Promyelocytes
    float
    C25294 (NCI Thesaurus ObjectClass)
    C20200 (NCI Thesaurus Property)
    C13114 (NCI Thesaurus Property-2)
    C25613 (NCI Thesaurus ValueDomain)
    C25712 (NCI Thesaurus ValueDomain-2)
    C0455279 (UMLS CUI-1)
    Neutrophil percentage
    Item
    Peripheral Neutrophils (%)
    float
    C25294 (NCI Thesaurus ObjectClass)
    C1171400 (UMLS CUI-1)
    C12533 (NCI Thesaurus Property)
    C20200 (NCI Thesaurus Property-2)
    C25613 (NCI Thesaurus ValueDomain)
    C25712 (NCI Thesaurus ValueDomain-2)
    BoneMarrowBiopsyDate
    Item
    Bone Marrow Biopsy Date
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C25367 (NCI Thesaurus ValueDomain-2)
    C15189 (NCI Thesaurus Property)
    C0005558 (UMLS 2011AA Property)
    C12431 (NCI Thesaurus ObjectClass)
    C0005953 (UMLS 2011AA ObjectClass)
    Blasts, Bone Marrow
    Item
    Marrow Blasts (%)
    float
    C25294 (NCI Thesaurus ObjectClass)
    C1982687 (UMLS CUI-1)
    C12431 (NCI Thesaurus Property)
    C20200 (NCI Thesaurus Property-2)
    C12918 (NCI Thesaurus Property-3)
    C25613 (NCI Thesaurus ValueDomain)
    C25712 (NCI Thesaurus ValueDomain-2)
    Bone Marrow Cellularity
    Item
    Marrow Cellularity (%)
    float
    C25294 (NCI Thesaurus ObjectClass)
    C12431 (NCI Thesaurus Property)
    C20200 (NCI Thesaurus Property-2)
    C37923 (NCI Thesaurus Property-3)
    C25613 (NCI Thesaurus ValueDomain)
    C25712 (NCI Thesaurus ValueDomain-2)
    C1561532 (UMLS CUI-1)
    Marrow Promyelocytes
    Item
    Marrow Promyelocytes (%)
    float
    C25294 (NCI Thesaurus ObjectClass)
    C12431 (NCI Thesaurus Property)
    C20200 (NCI Thesaurus Property-2)
    C13114 (NCI Thesaurus Property-3)
    C25613 (NCI Thesaurus ValueDomain)
    C25712 (NCI Thesaurus ValueDomain-2)
    C0005953 (UMLS CUI-1)
    C0033416 (UMLS CUI-2)
    Item
    Marrow Cellularity Status
    text
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C12431 (NCI Thesaurus Property)
    C0005953 (UMLS 2011AA Property)
    C20200 (NCI Thesaurus Property-2)
    C1274040 (UMLS 2011AA Property-2)
    C37923 (NCI Thesaurus Property-3)
    C1516377 (UMLS 2011AA Property-3)
    C25688 (NCI Thesaurus ValueDomain)
    C0449438 (UMLS 2011AA ValueDomain)
    Code List
    Marrow Cellularity Status
    CL Item
    Cellularity Status Of Bone Marrow Is Aplasitc (severely Hypocellular) (Aplastic (severely hypocellular))
    CL Item
    Cellularity Status Of Bone Marrow Unknown, Procedure Resulted In No Material To Analyze (Dry tap or inaspirable)
    CL Item
    Cellularity Status Of Bone Marrow Is Hypercellular (Hypercellular)
    CL Item
    Cellularity Status Of Bone Marrow Is Hypocellular (Hypocellular)
    CL Item
    Cellularity Status Of Bone Marrow Is Normocellular (Normocellular)
    CL Item
    Cellularity Status Of Bone Marrow Is Packed (intensely Hypercellular) (Packed (intensely hypercellular))
    PatientExtramedullaryDiseaseAssessmentDate
    Item
    Date of Examination for Extramedullary Disease
    date
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C20989 (NCI Thesaurus Property)
    C0031809 (UMLS 2011AA Property)
    C2991 (NCI Thesaurus Property-2)
    C0012634 (UMLS 2011AA Property-2)
    C25503 (NCI Thesaurus Property-3)
    C1517060 (UMLS 2011AA Property-3)
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    Item
    Extramedullary Disease Involvement
    text
    C13717 (NCI Thesaurus ValueDomain)
    C1515974 (UMLS 2011AA ValueDomain)
    C2991 (NCI Thesaurus ObjectClass)
    C0012634 (UMLS 2011AA ObjectClass)
    C25548 (NCI Thesaurus Property)
    C1314939 (UMLS 2011AA Property)
    C25503 (NCI Thesaurus Property-2)
    C1517060 (UMLS 2011AA Property-2)
    Code List
    Extramedullary Disease Involvement
    CL Item
    Gingival Hypertrophy (Gingival hypertrophy)
    CL Item
    Mediastinal Mass (Mediastinal mass)
    CL Item
    Peripheral Nervous System (Peripheral nervous system)
    C12465 (NCI Thesaurus)
    C0206417 (UMLS 2011AA)
    CL Item
    Skin (Skin (cutaneous))
    C12470 (NCI Thesaurus)
    C1123023 (UMLS 2011AA)
    CL Item
    Other Specify (Other)
    DiseaseExtramedullaryInvolvementOtherSite
    Item
    Other, specify
    text
    C13717 (NCI Thesaurus ValueDomain)
    C1515974 (UMLS 2011AA ValueDomain)
    C2991 (NCI Thesaurus ObjectClass)
    C0012634 (UMLS 2011AA ObjectClass)
    C25548 (NCI Thesaurus Property)
    C1314939 (UMLS 2011AA Property)
    C25503 (NCI Thesaurus Property-2)
    C1517060 (UMLS 2011AA Property-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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