ID

9031

Beskrivning

CALGB 50901 OPEN Registration Worksheet Ofatumumab in Treating Patients With Previously Untreated Stage II, Stage III, or Stage IV Follicular Non-Hodgkin Lymphoma Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A3A2758B-379D-E1D2-E040-BB89AD432897

Länk

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A3A2758B-379D-E1D2-E040-BB89AD432897

Nyckelord

  1. 2012-09-19 2012-09-19 -
  2. 2015-01-09 2015-01-09 - Martin Dugas
Uppladdad den

9 januari 2015

DOI

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Creative Commons BY-NC 3.0 Legacy

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    Lymphoma NCT01190449 Registration - CALGB 50901 OPEN Registration Worksheet - 3235818v1.0

    A Phase II Trial of Ofatumumab in Previously Untreated Follicular Non-Hodgkin's Lymphoma (NHL)

    Protocol Administration
    Beskrivning

    Protocol Administration

    Date Informed Consent Signed (MM DD YYYY)
    Beskrivning

    InformedConsentFormSignedDate

    Datatyp

    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
    HIPAA Authorization Date (MM DD YYYY)
    Beskrivning

    PatientSignedDischargeMedicalRecordDate

    Datatyp

    date

    Alias
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C25679
    NCI Metathesaurus Property
    C0012621
    NCI Thesaurus Property-2
    C45258
    UMLS 2011AA Property
    C0025102
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    Projected Start Date of Treatment (MM DD YYYY)
    Beskrivning

    Treatment Begin Date

    Datatyp

    date

    Alias
    NCI Thesaurus ObjectClass
    C15368
    NCI Thesaurus ObjectClass-2
    C25631
    NCI Thesaurus Property
    C25431
    UMLS CUI-1
    C3173309
    NCI Thesaurus Property-2
    C25275
    NCI Thesaurus ValueDomain
    C25164
    NCI Thesaurus ValueDomain-2
    C25431
    Pre-treatment Characteristics
    Beskrivning

    Pre-treatment Characteristics

    Disease
    Beskrivning

    NewCancerDiagnosisAnatomicSite

    Datatyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C13717
    UMLS 2011AA ValueDomain
    C1515974
    NCI Thesaurus ObjectClass
    C25586
    UMLS 2011AA ObjectClass
    C0205314
    NCI Thesaurus ObjectClass-2
    C9305
    UMLS 2011AA ObjectClass-2
    C0006826
    NCI Thesaurus Property
    C15220
    UMLS 2011AA Property
    C0011900
    Stage
    Beskrivning

    TumorGroupingStage

    Datatyp

    text

    Alias
    NCI Thesaurus ObjectClass
    C3262
    UMLS 2011AA ObjectClass
    C0027651
    NCI Thesaurus ValueDomain
    C16899
    UMLS 2011AA ValueDomain
    C1300072
    NCI Thesaurus Property
    C38027
    UMLS 2011AA Property
    C1519504
    Pathologic Type
    Beskrivning

    PersonMalignantNeoplasmPathologyClinicalTrialEligibilityCriteriaMalignantNeoplasmPathologyType

    Datatyp

    text

    Alias
    NCI Thesaurus ObjectClass
    C25190
    UMLS 2011AA ObjectClass
    C0027361
    NCI Thesaurus Property
    C9305
    UMLS 2011AA Property
    C0006826
    NCI Thesaurus Property-2
    C18189
    UMLS 2011AA Property-2
    C0030664
    NCI Thesaurus Property-3
    C16112
    UMLS 2011AA Property-3
    C1516637
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    Certification Of Eligibility
    Beskrivning

    Certification Of Eligibility

    In the opinion of the investigator, is the patient eligible (150910)
    Beskrivning

    Eligibility for trial

    Datatyp

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS CUI-1
    C1302261
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25171
    Certification Of Eligibility And Protocol Design
    Beskrivning

    Certification Of Eligibility And Protocol Design

    Assigned Treatment Arm
    Beskrivning

    Protocol Treatment Arm

    Datatyp

    text

    Alias
    NCI Thesaurus ObjectClass
    C15368
    NCI Thesaurus ObjectClass-2
    C42651
    UMLS CUI-1
    C1522541
    NCI Thesaurus Property
    C32141
    NCI Thesaurus Property-2
    C25426
    NCI Thesaurus ValueDomain
    C25284
    Initial Patient Consent For Specimen Use
    Beskrivning

    Initial Patient Consent For Specimen Use

    Patient's initial consent given for specimen use for genetic research relating to the study treatment (model consent question #1 If the patient answered "Yes" to this question, register the patient to 150910 during registration to 50901)
    Beskrivning

    SpecimenRelatedGeneticResearchConsentInd-2

    Datatyp

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C19157
    UMLS 2011AA ObjectClass
    C0370003
    NCI Thesaurus Property
    C15319
    NCI Thesaurus Property-2
    C25648
    UMLS 2011AA Property
    C0439849
    NCI Thesaurus Property-3
    C17938
    UMLS 2011AA Property-2
    C0314603
    NCI Thesaurus Property-4
    C25460
    UMLS 2011AA Property-3
    C1511481
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    Patient's Initial Consent given for specimen use for research on the patient's cancer (model consent question #2 If the patient answered "Yes" to this question, register the patient to 150910 during registration to 50901)
    Beskrivning

    BloodSpecimenMalignantNeoplasmRelatedResearchConsentInd-3

    Datatyp

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C12434
    UMLS 2011AA ObjectClass
    C0229664
    NCI Thesaurus ObjectClass-2
    C19157
    UMLS 2011AA ObjectClass-2
    C0370003
    NCI Thesaurus Property
    C15319
    NCI Thesaurus Property-2
    C25648
    UMLS 2011AA Property
    C0439849
    NCI Thesaurus Property-3
    C9305
    UMLS 2011AA Property-2
    C0006826
    NCI Thesaurus Property-4
    C25460
    UMLS 2011AA Property-3
    C1511481
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    In the opinion of the investigator, is the patient eligible (150910)
    Beskrivning

    Eligibility for trial

    Datatyp

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS CUI-1
    C1302261
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25171
    Initial Patient Consent For Specimen Use
    Beskrivning

    Initial Patient Consent For Specimen Use

    Patient's Initial Consent given for specimen kept for future use in research to learn about, prevent, or treat cancer (model consent question #3)
    Beskrivning

    PersonSpecimenMalignantNeoplasmResearchConsentInd-2

    Datatyp

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C25190
    UMLS 2011AA ObjectClass
    C0027361
    NCI Thesaurus Property
    C15319
    NCI Thesaurus Property-2
    C9305
    UMLS 2011AA Property
    C0006826
    NCI Thesaurus Property-3
    C19157
    UMLS 2011AA Property-2
    C0370003
    NCI Thesaurus Property-4
    C25460
    UMLS 2011AA Property-3
    C1511481
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    Patient's initial consent given for specimen(s) may be kept for use in research to learn about, prevent, or treat other health problems (for example: diabetes, Alzheimer's disease, or heart disease) (model consent question #4)
    Beskrivning

    PatientOtherDiseaseorDisorderClinicalStudyConsentInd-2

    Datatyp

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C17649
    UMLS 2011AA Property
    C0205394
    NCI Thesaurus Property-2
    C2991
    UMLS 2011AA Property-2
    C0012634
    NCI Thesaurus Property-3
    C15206
    UMLS 2011AA Property-3
    C0008972
    NCI Thesaurus Property-4
    C25460
    UMLS 2011AA Property-4
    C1511481
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    Patient's initial consent given for further contact to participate in research on future studies (model consent question #5)
    Beskrivning

    Permission to contact Patient

    Datatyp

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C16960
    UMLS CUI-1
    C1522577
    NCI Thesaurus Property
    C67527
    UMLS CUI-2
    C0521104
    NCI Thesaurus Property-2
    C25460
    NCI Thesaurus Property-3
    C16452
    NCI Thesaurus ValueDomain
    C38148

    Similar models

    A Phase II Trial of Ofatumumab in Previously Untreated Follicular Non-Hodgkin's Lymphoma (NHL)

    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    Protocol Administration
    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)
    PatientSignedDischargeMedicalRecordDate
    Item
    HIPAA Authorization Date (MM DD YYYY)
    date
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25679 (NCI Thesaurus Property)
    C0012621 (NCI Metathesaurus Property)
    C45258 (NCI Thesaurus Property-2)
    C0025102 (UMLS 2011AA Property)
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    Treatment Begin Date
    Item
    Projected Start Date of Treatment (MM DD YYYY)
    date
    C15368 (NCI Thesaurus ObjectClass)
    C25631 (NCI Thesaurus ObjectClass-2)
    C25431 (NCI Thesaurus Property)
    C3173309 (UMLS CUI-1)
    C25275 (NCI Thesaurus Property-2)
    C25164 (NCI Thesaurus ValueDomain)
    C25431 (NCI Thesaurus ValueDomain-2)
    Item Group
    Pre-treatment Characteristics
    Item
    Disease
    text
    C13717 (NCI Thesaurus ValueDomain)
    C1515974 (UMLS 2011AA ValueDomain)
    C25586 (NCI Thesaurus ObjectClass)
    C0205314 (UMLS 2011AA ObjectClass)
    C9305 (NCI Thesaurus ObjectClass-2)
    C0006826 (UMLS 2011AA ObjectClass-2)
    C15220 (NCI Thesaurus Property)
    C0011900 (UMLS 2011AA Property)
    Code List
    Disease
    CL Item
    Nhl (NHL)
    Item
    Stage
    text
    C3262 (NCI Thesaurus ObjectClass)
    C0027651 (UMLS 2011AA ObjectClass)
    C16899 (NCI Thesaurus ValueDomain)
    C1300072 (UMLS 2011AA ValueDomain)
    C38027 (NCI Thesaurus Property)
    C1519504 (UMLS 2011AA Property)
    Code List
    Stage
    CL Item
    Iii, Iv, Or Bulky Stage Ii (III, IV, or bulky stage II)
    Item
    Pathologic Type
    text
    C25190 (NCI Thesaurus ObjectClass)
    C0027361 (UMLS 2011AA ObjectClass)
    C9305 (NCI Thesaurus Property)
    C0006826 (UMLS 2011AA Property)
    C18189 (NCI Thesaurus Property-2)
    C0030664 (UMLS 2011AA Property-2)
    C16112 (NCI Thesaurus Property-3)
    C1516637 (UMLS 2011AA Property-3)
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    Code List
    Pathologic Type
    CL Item
    Follicular Lymphoma (Follicular Lymphoma)
    C3209 (NCI Thesaurus)
    C0024301 (UMLS 2011AA)
    Item Group
    Certification Of Eligibility
    Eligibility for trial
    Item
    In the opinion of the investigator, is the patient eligible (150910)
    boolean
    C38148 (NCI Thesaurus ValueDomain)
    C1302261 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C25171 (NCI Thesaurus Property)
    Item Group
    Certification Of Eligibility And Protocol Design
    Item
    Assigned Treatment Arm
    text
    C15368 (NCI Thesaurus ObjectClass)
    C42651 (NCI Thesaurus ObjectClass-2)
    C1522541 (UMLS CUI-1)
    C32141 (NCI Thesaurus Property)
    C25426 (NCI Thesaurus Property-2)
    C25284 (NCI Thesaurus ValueDomain)
    Code List
    Assigned Treatment Arm
    CL Item
    Ofatumumab 500 Mg (Ofatumumab 500 mg)
    CL Item
    Ofatumumab 1000 Mg (Ofatumumab 1000 mg)
    Item Group
    Initial Patient Consent For Specimen Use
    SpecimenRelatedGeneticResearchConsentInd-2
    Item
    Patient's initial consent given for specimen use for genetic research relating to the study treatment (model consent question #1 If the patient answered "Yes" to this question, register the patient to 150910 during registration to 50901)
    boolean
    C19157 (NCI Thesaurus ObjectClass)
    C0370003 (UMLS 2011AA ObjectClass)
    C15319 (NCI Thesaurus Property)
    C25648 (NCI Thesaurus Property-2)
    C0439849 (UMLS 2011AA Property)
    C17938 (NCI Thesaurus Property-3)
    C0314603 (UMLS 2011AA Property-2)
    C25460 (NCI Thesaurus Property-4)
    C1511481 (UMLS 2011AA Property-3)
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    BloodSpecimenMalignantNeoplasmRelatedResearchConsentInd-3
    Item
    Patient's Initial Consent given for specimen use for research on the patient's cancer (model consent question #2 If the patient answered "Yes" to this question, register the patient to 150910 during registration to 50901)
    boolean
    C12434 (NCI Thesaurus ObjectClass)
    C0229664 (UMLS 2011AA ObjectClass)
    C19157 (NCI Thesaurus ObjectClass-2)
    C0370003 (UMLS 2011AA ObjectClass-2)
    C15319 (NCI Thesaurus Property)
    C25648 (NCI Thesaurus Property-2)
    C0439849 (UMLS 2011AA Property)
    C9305 (NCI Thesaurus Property-3)
    C0006826 (UMLS 2011AA Property-2)
    C25460 (NCI Thesaurus Property-4)
    C1511481 (UMLS 2011AA Property-3)
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    Eligibility for trial
    Item
    In the opinion of the investigator, is the patient eligible (150910)
    boolean
    C38148 (NCI Thesaurus ValueDomain)
    C1302261 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C25171 (NCI Thesaurus Property)
    Item Group
    Initial Patient Consent For Specimen Use
    PersonSpecimenMalignantNeoplasmResearchConsentInd-2
    Item
    Patient's Initial Consent given for specimen kept for future use in research to learn about, prevent, or treat cancer (model consent question #3)
    boolean
    C25190 (NCI Thesaurus ObjectClass)
    C0027361 (UMLS 2011AA ObjectClass)
    C15319 (NCI Thesaurus Property)
    C9305 (NCI Thesaurus Property-2)
    C0006826 (UMLS 2011AA Property)
    C19157 (NCI Thesaurus Property-3)
    C0370003 (UMLS 2011AA Property-2)
    C25460 (NCI Thesaurus Property-4)
    C1511481 (UMLS 2011AA Property-3)
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    PatientOtherDiseaseorDisorderClinicalStudyConsentInd-2
    Item
    Patient's initial consent given for specimen(s) may be kept for use in research to learn about, prevent, or treat other health problems (for example: diabetes, Alzheimer's disease, or heart disease) (model consent question #4)
    boolean
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C17649 (NCI Thesaurus Property)
    C0205394 (UMLS 2011AA Property)
    C2991 (NCI Thesaurus Property-2)
    C0012634 (UMLS 2011AA Property-2)
    C15206 (NCI Thesaurus Property-3)
    C0008972 (UMLS 2011AA Property-3)
    C25460 (NCI Thesaurus Property-4)
    C1511481 (UMLS 2011AA Property-4)
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    Permission to contact Patient
    Item
    Patient's initial consent given for further contact to participate in research on future studies (model consent question #5)
    boolean
    C16960 (NCI Thesaurus ObjectClass)
    C1522577 (UMLS CUI-1)
    C67527 (NCI Thesaurus Property)
    C0521104 (UMLS CUI-2)
    C25460 (NCI Thesaurus Property-2)
    C16452 (NCI Thesaurus Property-3)
    C38148 (NCI Thesaurus ValueDomain)

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