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ID

2309

Descrição

AMC-075A 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=9A5E5C94-089E-8CEB-E040-BB89AD430BF6

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=9A5E5C94-089E-8CEB-E040-BB89AD430BF6

Palavras-chave

Versões (3)
  1. 19/09/2012 19/09/2012 -
  2. 28/05/2015 28/05/2015 -
  3. 03/06/2015 03/06/2015 -
Transferido a

19 de setembro de 2012

DOI

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Creative Commons BY-NC 3.0 Legacy
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    Lymphoma NCT01193842 Registration - AMC-075A Enrollment Form (ENR) - 3185197v1.0

    Inglês

    No Instruction available.

    1 Formulários  
    1. StudyEvent: AMC-075A Enrollment Form (ENR)
      1. No Instruction available.
    Unnamed1
    Descrição

    Unnamed1

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

    TreatmentProjectedBeginDate

    Tipo de dados

    date

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

    TreatingPhysicianOrParticipatingInvestigatorName

    Tipo de dados

    text

    Alias
    NCI Thesaurus ObjectClass
    C25608
    UMLS 2011AA ObjectClass
    C0679823
    NCI Thesaurus ObjectClass
    C37998
    UMLS 2011AA ObjectClass
    C1518602
    NCI Thesaurus ObjectClass
    C51883
    UMLS 2011AA ObjectClass
    C1710470
    NCI Thesaurus ObjectClass
    C25936
    UMLS 2011AA ObjectClass
    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)
    Descrição

    InstitutionContactTelephoneNumber

    Tipo de dados

    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
    C25461
    UMLS 2011AA ObjectClass
    C0337611
    Inclusion/exclusion Criteria
    Descrição

    Inclusion/exclusion Criteria

    Inclusion Criteria
    Descrição

    AIDSMalignancyConsortiumPatientInclusionClinicalTrialEligibilityCriteria075Type

    Tipo de dados

    text

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

    Exclusion Criteria

    Exclusion Criteria
    Descrição

    AIDSMalignancyConsortiumPatientExclusionClinicalTrialEligibilityCriteria075Type

    Tipo de dados

    text

    Alias
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus ObjectClass
    C19707
    UMLS 2011AA ObjectClass
    C1515830
    NCI Thesaurus Property
    C16112
    UMLS 2011AA Property
    C1516637
    NCI Thesaurus Property
    C25370
    UMLS 2011AA Property
    C0680251
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    Exclusion Criteria
    Descrição

    Exclusion Criteria

    Age (in years)
    Descrição

    PatientAgeYearCount

    Tipo de dados

    double

    Alias
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus ValueDomain
    C29848
    UMLS 2011AA ValueDomain
    C0439234
    NCI Thesaurus ValueDomain
    C25463
    UMLS 2011AA ValueDomain
    C0750480
    NCI Thesaurus Property
    C25150
    UMLS 2011AA Property
    C0001779
    Date Informed Consent Signed (mm/dd/yyyy)
    Descrição

    InformedConsentFormSignedDate

    Tipo de dados

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ValueDomain
    C25367
    NCI Thesaurus ObjectClass
    C16468
    UMLS 2011AA ObjectClass
    C0009797
    NCI Thesaurus Property
    C25679
    Enrollment Stratification Data
    Descrição

    Enrollment Stratification Data

    Modified Ann Arbor Stage
    Descrição

    LymphomaAnnArborLymphomaStagingSystemClassificationStage

    Tipo de dados

    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
    Descrição

    InternationalPrognosticIndexPatientLactateDehydrogenaseAssessmentInd-2

    Tipo de dados

    text

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

    LaboratoryProcedureTumorMarkerKi-67AntigenResultType

    Tipo de dados

    text

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

    HematopoieticDiseaseDiagnosisType

    Tipo de dados

    text

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

    PatientInternationalPrognosticIndexRiskStratificationType

    Tipo de dados

    text

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

    Specimen Consent

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

    BloodTissueSpecimenOtherDiseasesandDisordersFutureResearchConsentInd-2

    Tipo de dados

    text

    Alias
    NCI Thesaurus ObjectClass
    C12801
    UMLS 2011AA ObjectClass
    C0040300
    NCI Thesaurus ObjectClass
    C12434
    UMLS 2011AA ObjectClass
    C0229664
    NCI Thesaurus ObjectClass
    C19157
    UMLS 2011AA ObjectClass
    C0370003
    NCI Thesaurus Property
    C17649
    UMLS 2011AA Property
    C0205394
    NCI Thesaurus Property
    C15319
    NCI Thesaurus Property
    C67527
    UMLS 2011AA Property
    C0016884
    NCI Thesaurus Property
    C2991
    UMLS 2011AA Property
    C0012634
    NCI Thesaurus Property
    C25460
    UMLS 2011AA Property
    C1511481
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    Comments
    Descrição

    Comments

    Comments
    Descrição

    ResearchCommentsText

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25704
    UMLS 2011AA ValueDomain
    C1527021
    NCI Thesaurus ObjectClass
    C15319
    NCI Thesaurus Property
    C25393
    UMLS 2011AA Property
    C0282411
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    Similar models

    No Instruction available.

    1 Formulários
    1. StudyEvent: AMC-075A Enrollment Form (ENR)
      1. No Instruction available.
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    Unnamed1
    TreatmentProjectedBeginDate
    Item
    Projected Start Date of Treatment (mm/dd/yyyy)
    date
    C15368 (NCI Thesaurus ObjectClass)
    C25631 (NCI Thesaurus ObjectClass)
    C25431 (NCI Thesaurus Property)
    C0439659 (UMLS 2011AA Property)
    C25275 (NCI Thesaurus Property)
    C2745955 (UMLS 2011AA Property)
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C25431 (NCI Thesaurus ValueDomain)
    C0439659 (UMLS 2011AA ValueDomain)
    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)
    C1518602 (UMLS 2011AA ObjectClass)
    C51883 (NCI Thesaurus ObjectClass)
    C1710470 (UMLS 2011AA ObjectClass)
    C25936 (NCI Thesaurus ObjectClass)
    C0035173 (UMLS 2011AA ObjectClass)
    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)
    C0337611 (UMLS 2011AA ObjectClass)
    Item Group
    Inclusion/exclusion Criteria
    Item
    Inclusion Criteria
    text
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C16112 (NCI Thesaurus Property)
    C1516637 (UMLS 2011AA Property)
    C19707 (NCI Thesaurus ObjectClass)
    C1515830 (UMLS 2011AA ObjectClass)
    C25532 (NCI Thesaurus Property)
    C1512693 (UMLS 2011AA Property)
    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)
    C1515830 (UMLS 2011AA ObjectClass)
    C16112 (NCI Thesaurus Property)
    C1516637 (UMLS 2011AA Property)
    C25370 (NCI Thesaurus Property)
    C0680251 (UMLS 2011AA Property)
    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)
    Item Group
    Exclusion Criteria
    PatientAgeYearCount
    Item
    Age (in years)
    double
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C29848 (NCI Thesaurus ValueDomain)
    C0439234 (UMLS 2011AA ValueDomain)
    C25463 (NCI Thesaurus ValueDomain)
    C0750480 (UMLS 2011AA ValueDomain)
    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)
    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)
    Item
    Is the serum LDH elevated
    text
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C20118 (NCI Thesaurus ObjectClass)
    C1512894 (UMLS 2011AA ObjectClass)
    C20989 (NCI Thesaurus Property)
    C0031809 (UMLS 2011AA Property)
    C25184 (NCI Thesaurus Property)
    C0022917 (UMLS 2011AA Property)
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    CL.4
    Code List
    Is the serum LDH elevated
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    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)
    C0041365 (UMLS 2011AA Property)
    C17675 (NCI Thesaurus Property)
    C0208804 (UMLS 2011AA Property)
    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)
    C0229601 (UMLS 2011AA ObjectClass)
    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)
    C1512894 (UMLS 2011AA Property)
    C25689 (NCI Thesaurus Property)
    C1514983 (UMLS 2011AA Property)
    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)
    Item
    Does the participant agree to have excess specimens from this study stored for future AIDS-related research (or leftover)
    text
    C12801 (NCI Thesaurus ObjectClass)
    C0040300 (UMLS 2011AA ObjectClass)
    C12434 (NCI Thesaurus ObjectClass)
    C0229664 (UMLS 2011AA ObjectClass)
    C19157 (NCI Thesaurus ObjectClass)
    C0370003 (UMLS 2011AA ObjectClass)
    C17649 (NCI Thesaurus Property)
    C0205394 (UMLS 2011AA Property)
    C15319 (NCI Thesaurus Property)
    C67527 (NCI Thesaurus Property)
    C0016884 (UMLS 2011AA Property)
    C2991 (NCI Thesaurus Property)
    C0012634 (UMLS 2011AA Property)
    C25460 (NCI Thesaurus Property)
    C1511481 (UMLS 2011AA Property)
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    CL.8
    Code List
    Does the participant agree to have excess specimens from this study stored for future AIDS-related research (or leftover)
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    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)
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