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10386

Description

AMC-075B Enrollment Form (ENR) Vorinostat and Combination Chemotherapy With Rituximab in Treating Patients With Previously Untreated HIV-Related Diffuse Large B-Cell Non-Hodgkin Lymphoma Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=9B26D8A0-BAA8-E8FB-E040-BB89AD4335F8

Lien

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=9B26D8A0-BAA8-E8FB-E040-BB89AD4335F8

Mots-clés

Versions (3)
  1. 19/09/2012 19/09/2012 -
  2. 28/05/2015 28/05/2015 -
  3. 03/06/2015 03/06/2015 -
Téléchargé le

28 mai 2015

DOI

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Licence

Creative Commons BY-NC 3.0 Legacy
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    AMC-075B Enrollment Form (ENR)

    Anglais

    No Instruction available.

    1 Formulaires  
    1. StudyEvent: AMC-075B Enrollment Form (ENR)
      1. No Instruction available.
    Header Module
    Description

    Header Module

    Projected Start Date of Treatment (mm/dd/yyyy)
    Description

    TreatmentProjectedBeginDate

    Type de données

    date

    Alias
    NCI Thesaurus ObjectClass
    C15368
    NCI Thesaurus ObjectClass-2
    C25631
    NCI Thesaurus Property
    C25431
    UMLS 2011AA Property
    C0439659
    NCI Thesaurus Property-2
    C25275
    UMLS 2011AA Property-2
    C2745955
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ValueDomain-2
    C25431
    UMLS 2011AA ValueDomain-2
    C0439659
    Treating Investigator (The protocol chair may contact the investigator with questions regarding the participant enrollment and follow up)
    Description

    TreatingPhysicianOrParticipatingInvestigatorName

    Type de données

    text

    Alias
    NCI Thesaurus ObjectClass
    C25608
    UMLS 2011AA ObjectClass
    C0679823
    NCI Thesaurus ObjectClass-2
    C37998
    UMLS 2011AA ObjectClass-2
    C1518602
    NCI Thesaurus ObjectClass-3
    C51883
    UMLS 2011AA ObjectClass-3
    C1710470
    NCI Thesaurus ObjectClass-4
    C25936
    UMLS 2011AA ObjectClass-4
    C0035173
    NCI Thesaurus Property
    C25191
    UMLS 2011AA Property
    C1547383
    NCI Thesaurus ValueDomain
    C25191
    UMLS 2011AA ValueDomain
    C1547383
    Institution contact phone number (This is the phone number where the investigator can be reached directly)
    Description

    InstitutionContactTelephoneNumber

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS 2011AA ValueDomain
    C0237753
    NCI Thesaurus ObjectClass
    C21541
    UMLS 2011AA ObjectClass
    C0018704
    NCI Thesaurus Property
    C25395
    UMLS 2011AA Property
    C0039457
    NCI Thesaurus ObjectClass-2
    C25461
    UMLS 2011AA ObjectClass-2
    C0337611
    Inclusion/exclusion Criteria
    Description

    Inclusion/exclusion Criteria

    Inclusion Criteria
    Description

    AIDSMalignancyConsortiumPatientInclusionClinicalTrialEligibilityCriteria075Type

    Type de données

    text

    Alias
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus ObjectClass-2
    C19707
    UMLS 2011AA ObjectClass-2
    C1515830
    NCI Thesaurus Property
    C16112
    UMLS 2011AA Property
    C1516637
    NCI Thesaurus Property-2
    C25532
    UMLS 2011AA Property-2
    C1512693
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    Exclusion Criteria
    Description

    Exclusion Criteria

    Exclusion Criteria
    Description

    AIDSMalignancyConsortiumPatientExclusionClinicalTrialEligibilityCriteria075Type

    Type de données

    text

    Alias
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus ObjectClass-2
    C19707
    UMLS 2011AA ObjectClass-2
    C1515830
    NCI Thesaurus Property
    C16112
    UMLS 2011AA Property
    C1516637
    NCI Thesaurus Property-2
    C25370
    UMLS 2011AA Property-2
    C0680251
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    Age (in years)
    Description

    PatientAgeYearCount

    Type de données

    float

    Alias
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus ValueDomain
    C29848
    UMLS 2011AA ValueDomain
    C0439234
    NCI Thesaurus ValueDomain-2
    C25463
    UMLS 2011AA ValueDomain-2
    C0750480
    NCI Thesaurus Property
    C25150
    UMLS 2011AA Property
    C0001779
    Date Informed Consent Signed (mm/dd/yyyy)
    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
    Enrollment Stratification Data
    Description

    Enrollment Stratification Data

    Modified Ann Arbor Stage
    Description

    LymphomaAnnArborLymphomaStagingSystemClassificationStage

    Type de données

    text

    Alias
    NCI Thesaurus ObjectClass
    C3208
    UMLS 2011AA ObjectClass
    C0024299
    NCI Thesaurus ValueDomain
    C16899
    UMLS 2011AA ValueDomain
    C1300072
    NCI Thesaurus Property
    C25161
    UMLS 2011AA Property
    C0008902
    Is the serum LDH elevated
    Description

    InternationalPrognosticIndexPatientLactateDehydrogenaseAssessmentInd-2

    Type de données

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus ObjectClass-2
    C20118
    UMLS 2011AA ObjectClass-2
    C1512894
    NCI Thesaurus Property
    C20989
    UMLS 2011AA Property
    C0031809
    NCI Thesaurus Property-2
    C25184
    UMLS 2011AA Property-2
    C0022917
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    Ki-67 Staining Index Score
    Description

    LaboratoryProcedureTumorMarkerKi-67AntigenResultType

    Type de données

    text

    Alias
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    NCI Thesaurus Property-2
    C17220
    UMLS 2011AA Property-2
    C0041365
    NCI Thesaurus Property-3
    C17675
    UMLS 2011AA Property-3
    C0208804
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    Hematopoietic Diagnosis
    Description

    HematopoieticDiseaseDiagnosisType

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    NCI Thesaurus ObjectClass
    C2991
    UMLS 2011AA ObjectClass
    C0012634
    NCI Thesaurus ObjectClass-2
    C13324
    UMLS 2011AA ObjectClass-2
    C0229601
    NCI Thesaurus Property
    C15220
    UMLS 2011AA Property
    C0011900
    IPI Stratification Score (Participant)
    Description

    PatientInternationalPrognosticIndexRiskStratificationType

    Type de données

    text

    Alias
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C17102
    UMLS 2011AA Property
    C0035647
    NCI Thesaurus Property-2
    C20118
    UMLS 2011AA Property-2
    C1512894
    NCI Thesaurus Property-3
    C25689
    UMLS 2011AA Property-3
    C1514983
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    Specimen Consent
    Description

    Specimen Consent

    Does the participant agree to have excess specimens from this study stored for future AIDS-related research (or leftover)
    Description

    BloodTissueSpecimenOtherDiseasesandDisordersFutureResearchConsentInd-2

    Type de données

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C12801
    UMLS 2011AA ObjectClass
    C0040300
    NCI Thesaurus ObjectClass-2
    C12434
    UMLS 2011AA ObjectClass-2
    C0229664
    NCI Thesaurus ObjectClass-3
    C19157
    UMLS 2011AA ObjectClass-3
    C0370003
    NCI Thesaurus Property
    C17649
    UMLS 2011AA Property
    C0205394
    NCI Thesaurus Property-2
    C15319
    NCI Thesaurus Property-3
    C67527
    UMLS 2011AA Property-2
    C0016884
    NCI Thesaurus Property-4
    C2991
    UMLS 2011AA Property-3
    C0012634
    NCI Thesaurus Property-5
    C25460
    UMLS 2011AA Property-4
    C1511481
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    Comments
    Description

    Comments

    Comments
    Description

    ResearchCommentsText

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25704
    UMLS 2011AA ValueDomain
    C1527021
    NCI Thesaurus ObjectClass
    C15319
    NCI Thesaurus Property
    C25393
    UMLS 2011AA Property
    C0282411
    Retour au début de la page

    Similar models

    No Instruction available.

    1 Formulaires
    1. StudyEvent: AMC-075B Enrollment Form (ENR)
      1. No Instruction available.
    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    Alias
    Item Group
    Header Module
    TreatmentProjectedBeginDate
    Item
    Projected Start Date of Treatment (mm/dd/yyyy)
    date
    C15368 (NCI Thesaurus ObjectClass)
    C25631 (NCI Thesaurus ObjectClass-2)
    C25431 (NCI Thesaurus Property)
    C0439659 (UMLS 2011AA Property)
    C25275 (NCI Thesaurus Property-2)
    C2745955 (UMLS 2011AA Property-2)
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C25431 (NCI Thesaurus ValueDomain-2)
    C0439659 (UMLS 2011AA ValueDomain-2)
    TreatingPhysicianOrParticipatingInvestigatorName
    Item
    Treating Investigator (The protocol chair may contact the investigator with questions regarding the participant enrollment and follow up)
    text
    C25608 (NCI Thesaurus ObjectClass)
    C0679823 (UMLS 2011AA ObjectClass)
    C37998 (NCI Thesaurus ObjectClass-2)
    C1518602 (UMLS 2011AA ObjectClass-2)
    C51883 (NCI Thesaurus ObjectClass-3)
    C1710470 (UMLS 2011AA ObjectClass-3)
    C25936 (NCI Thesaurus ObjectClass-4)
    C0035173 (UMLS 2011AA ObjectClass-4)
    C25191 (NCI Thesaurus Property)
    C1547383 (UMLS 2011AA Property)
    C25191 (NCI Thesaurus ValueDomain)
    C1547383 (UMLS 2011AA ValueDomain)
    InstitutionContactTelephoneNumber
    Item
    Institution contact phone number (This is the phone number where the investigator can be reached directly)
    text
    C25337 (NCI Thesaurus ValueDomain)
    C0237753 (UMLS 2011AA ValueDomain)
    C21541 (NCI Thesaurus ObjectClass)
    C0018704 (UMLS 2011AA ObjectClass)
    C25395 (NCI Thesaurus Property)
    C0039457 (UMLS 2011AA Property)
    C25461 (NCI Thesaurus ObjectClass-2)
    C0337611 (UMLS 2011AA ObjectClass-2)
    Item Group
    Inclusion/exclusion Criteria
    Item
    Inclusion Criteria
    text
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C19707 (NCI Thesaurus ObjectClass-2)
    C1515830 (UMLS 2011AA ObjectClass-2)
    C16112 (NCI Thesaurus Property)
    C1516637 (UMLS 2011AA Property)
    C25532 (NCI Thesaurus Property-2)
    C1512693 (UMLS 2011AA Property-2)
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    CL.1
    Code List
    Inclusion Criteria
    CL Item
    Participant's Age (in Years) (Participant's age (in years))
    Item Group
    Exclusion Criteria
    Item
    Exclusion Criteria
    text
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C19707 (NCI Thesaurus ObjectClass-2)
    C1515830 (UMLS 2011AA ObjectClass-2)
    C16112 (NCI Thesaurus Property)
    C1516637 (UMLS 2011AA Property)
    C25370 (NCI Thesaurus Property-2)
    C0680251 (UMLS 2011AA Property-2)
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    CL.2
    Code List
    Exclusion Criteria
    CL Item
    Is The Participant Hepatitis B Core Antibody Positive (Is the participant Hepatitis B core antibody positive)
    PatientAgeYearCount
    Item
    Age (in years)
    float
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C29848 (NCI Thesaurus ValueDomain)
    C0439234 (UMLS 2011AA ValueDomain)
    C25463 (NCI Thesaurus ValueDomain-2)
    C0750480 (UMLS 2011AA ValueDomain-2)
    C25150 (NCI Thesaurus Property)
    C0001779 (UMLS 2011AA Property)
    InformedConsentFormSignedDate
    Item
    Date Informed Consent Signed (mm/dd/yyyy)
    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)
    Item Group
    Enrollment Stratification Data
    Item
    Modified Ann Arbor Stage
    text
    C3208 (NCI Thesaurus ObjectClass)
    C0024299 (UMLS 2011AA ObjectClass)
    C16899 (NCI Thesaurus ValueDomain)
    C1300072 (UMLS 2011AA ValueDomain)
    C25161 (NCI Thesaurus Property)
    C0008902 (UMLS 2011AA Property)
    CL.3
    Code List
    Modified Ann Arbor Stage
    CL Item
    I (I)
    CL Item
    Ii (II)
    CL Item
    Iii (III)
    CL Item
    Iv (IV)
    InternationalPrognosticIndexPatientLactateDehydrogenaseAssessmentInd-2
    Item
    Is the serum LDH elevated
    boolean
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C20118 (NCI Thesaurus ObjectClass-2)
    C1512894 (UMLS 2011AA ObjectClass-2)
    C20989 (NCI Thesaurus Property)
    C0031809 (UMLS 2011AA Property)
    C25184 (NCI Thesaurus Property-2)
    C0022917 (UMLS 2011AA Property-2)
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    Item
    Ki-67 Staining Index Score
    text
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    C17220 (NCI Thesaurus Property-2)
    C0041365 (UMLS 2011AA Property-2)
    C17675 (NCI Thesaurus Property-3)
    C0208804 (UMLS 2011AA Property-3)
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    CL.5
    Code List
    Ki-67 Staining Index Score
    CL Item
    < 80% (< 80%)
    CL Item
    >= 80% (>= 80%)
    CL Item
    Inconclusive (Inconclusive)
    C75569 (NCI Thesaurus)
    C1629507 (UMLS 2011AA)
    Item
    Hematopoietic Diagnosis
    text
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    C2991 (NCI Thesaurus ObjectClass)
    C0012634 (UMLS 2011AA ObjectClass)
    C13324 (NCI Thesaurus ObjectClass-2)
    C0229601 (UMLS 2011AA ObjectClass-2)
    C15220 (NCI Thesaurus Property)
    C0011900 (UMLS 2011AA Property)
    CL.6
    Code List
    Hematopoietic Diagnosis
    CL Item
    Activated B-cell-like Diffuse Large B-cell Lymphoma (ABC)
    C36081 (NCI Thesaurus)
    C1333296 (UMLS 2011AA)
    CL Item
    Germinal Center B-cell-like Diffuse Large B-cell Lymphoma (GCB)
    C36080 (NCI Thesaurus)
    C1333295 (UMLS 2011AA)
    Item
    IPI Stratification Score (Participant)
    text
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C17102 (NCI Thesaurus Property)
    C0035647 (UMLS 2011AA Property)
    C20118 (NCI Thesaurus Property-2)
    C1512894 (UMLS 2011AA Property-2)
    C25689 (NCI Thesaurus Property-3)
    C1514983 (UMLS 2011AA Property-3)
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    CL.7
    Code List
    IPI Stratification Score (Participant)
    CL Item
    An International Prognostic Index Score Of 0 Or 1 (0 or 1)
    CL Item
    An International Prognostic Index Score Of 2 Or 3 (2 or 3)
    BloodTissueSpecimenOtherDiseasesandDisordersFutureResearchConsentInd-2
    Item
    Does the participant agree to have excess specimens from this study stored for future AIDS-related research (or leftover)
    boolean
    C12801 (NCI Thesaurus ObjectClass)
    C0040300 (UMLS 2011AA ObjectClass)
    C12434 (NCI Thesaurus ObjectClass-2)
    C0229664 (UMLS 2011AA ObjectClass-2)
    C19157 (NCI Thesaurus ObjectClass-3)
    C0370003 (UMLS 2011AA ObjectClass-3)
    C17649 (NCI Thesaurus Property)
    C0205394 (UMLS 2011AA Property)
    C15319 (NCI Thesaurus Property-2)
    C67527 (NCI Thesaurus Property-3)
    C0016884 (UMLS 2011AA Property-2)
    C2991 (NCI Thesaurus Property-4)
    C0012634 (UMLS 2011AA Property-3)
    C25460 (NCI Thesaurus Property-5)
    C1511481 (UMLS 2011AA Property-4)
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    Item Group
    Comments
    ResearchCommentsText
    Item
    Comments
    text
    C25704 (NCI Thesaurus ValueDomain)
    C1527021 (UMLS 2011AA ValueDomain)
    C15319 (NCI Thesaurus ObjectClass)
    C25393 (NCI Thesaurus Property)
    C0282411 (UMLS 2011AA Property)
    Retour au début de la page 

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