ID

9023

Descrição

CALGB-31004 OPEN Registration/Randomization Worksheet (SPARE Phase IB) Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=B5A21D41-B9DA-D92A-E040-BB89AD4353CA

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=B5A21D41-B9DA-D92A-E040-BB89AD4353CA

Palavras-chave

  1. 19/09/2012 19/09/2012 -
  2. 09/01/2015 09/01/2015 - Martin Dugas
  3. 09/01/2015 09/01/2015 - Martin Dugas
Transferido a

9 de janeiro de 2015

DOI

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Licença

Creative Commons BY-NC 3.0 Legacy

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    Malignant Mesothelioma Registration - CALGB-31004 OPEN Registration/Randomization Worksheet (SPARE Phase IB) - 3342180v1.0

    A Phase IB/Randomized Phase II Placebo-controlled Study of Linsitinib (OSI-906; NSC #751082) in Combination with Chemotherapy in Previously Treated Malignant Mesothelioma

    Protocol Administration
    Descrição

    Protocol Administration

    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-2
    C25367
    NCI Thesaurus ObjectClass
    C16468
    UMLS 2011AA ObjectClass
    C0009797
    NCI Thesaurus Property
    C25679
    HIPAA Authorization Date (MM DD YYYY)
    Descrição

    PatientSignedDischargeMedicalRecordDate

    Tipo de dados

    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)
    Descrição

    Treatment Begin Date

    Tipo de dados

    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
    Descrição

    Pre-treatment Characteristics

    Performance Status
    Descrição

    ECOG Performance Status

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25664
    UMLS CUI-1
    C1520224
    NCI Thesaurus Property
    C25367
    NCI Thesaurus ValueDomain-2
    C25491
    NCI Thesaurus ObjectClass
    C20641
    Height (cm)
    Descrição

    Patient Height

    Tipo de dados

    float

    Unidades de medida
    • cm
    Alias
    NCI Thesaurus ValueDomain
    C25209
    UMLS CUI-1
    C0489786
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25347
    cm
    Weight (kg)
    Descrição

    Patient Weight

    Tipo de dados

    float

    Unidades de medida
    • Kg
    Alias
    NCI Thesaurus ValueDomain
    C25209
    UMLS CUI-1
    C0005910
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25208
    Kg
    Disease code (mesothelioma)
    Descrição

    MedicalDictionaryforRegulatoryActivitiesTerminologyIdentifierCode

    Tipo de dados

    float

    Alias
    NCI Thesaurus ValueDomain
    C25162
    UMLS 2011AA ValueDomain
    C0805701
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    NCI Metathesaurus ObjectClass
    CL104089
    NCI Thesaurus ValueDomain-2
    C43820
    UMLS 2011AA ValueDomain-2
    C1140263
    Certification Of Eligibility
    Descrição

    Certification Of Eligibility

    In the opinion of the investigator, is the patient eligible
    Descrição

    Eligibility for trial

    Tipo de dados

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS CUI-1
    C1302261
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25171
    Prior Therapy
    Descrição

    Prior Therapy

    Prior Cancer Therapies (Mark all that apply with an X.)
    Descrição

    Prior therapy type

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS CUI-1
    C1514463
    NCI Thesaurus ObjectClass
    C25629
    NCI Thesaurus ObjectClass-2
    C15368
    NCI Thesaurus Property
    C25365
    Number of regimens (Chemotherapy multiple agents systemic)
    Descrição

    PriorMultipleAgentChemotherapyAdministeredCount

    Tipo de dados

    float

    Alias
    NCI Thesaurus ObjectClass
    C15632
    UMLS 2011AA ObjectClass
    C0392920
    NCI Thesaurus ObjectClass-2
    C25629
    UMLS 2011AA ObjectClass-2
    C0332152
    NCI Thesaurus ObjectClass-3
    C17648
    UMLS 2011AA ObjectClass-3
    C0439064
    NCI Thesaurus ObjectClass-4
    C1708
    UMLS 2011AA ObjectClass-4
    C0450442
    NCI Thesaurus Property
    C25382
    UMLS 2011AA Property
    C1521801
    NCI Thesaurus ValueDomain
    C25463
    UMLS 2011AA ValueDomain
    C0750480
    Number of regimens (Chemotherapy non-cytotoxic)
    Descrição

    PriorNon-cytotoxicAgentChemotherapyAdministeredCount

    Tipo de dados

    float

    Alias
    NCI Thesaurus ObjectClass
    C15632
    UMLS 2011AA ObjectClass
    C0392920
    NCI Thesaurus ObjectClass-2
    C25629
    UMLS 2011AA ObjectClass-2
    C0332152
    NCI Thesaurus ObjectClass-3
    C83487
    UMLS 2011AA ObjectClass-3
    C2827065
    NCI Thesaurus Property
    C25382
    UMLS 2011AA Property
    C1521801
    NCI Thesaurus ValueDomain
    C25463
    UMLS 2011AA ValueDomain
    C0750480
    Number of regimens (Chemotherapy - NOS)
    Descrição

    PriorChemotherapyRegimenNumber

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS 2011AA ValueDomain
    C0237753
    NCI Thesaurus ObjectClass
    C15632
    UMLS 2011AA ObjectClass
    C0392920
    NCI Thesaurus ObjectClass-2
    C25629
    UMLS 2011AA ObjectClass-2
    C0332152
    NCI Thesaurus Property
    C15697
    UMLS 2011AA Property
    C0040808
    Number of regimens (Chemotherapy single agent systemic)
    Descrição

    SingleAgentSystemicChemotherapyAdministeredCount

    Tipo de dados

    float

    Alias
    NCI Thesaurus ValueDomain
    C25463
    UMLS 2011AA ValueDomain
    C0750480
    NCI Thesaurus ObjectClass
    C15756
    UMLS 2011AA ObjectClass
    C0854619
    NCI Thesaurus Property
    C25382
    UMLS 2011AA Property
    C1521801

    Similar models

    A Phase IB/Randomized Phase II Placebo-controlled Study of Linsitinib (OSI-906; NSC #751082) in Combination with Chemotherapy in Previously Treated Malignant Mesothelioma

    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    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
    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)
    Patient Height
    Item
    Height (cm)
    float
    C25209 (NCI Thesaurus ValueDomain)
    C0489786 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C25347 (NCI Thesaurus Property)
    Patient Weight
    Item
    Weight (kg)
    float
    C25209 (NCI Thesaurus ValueDomain)
    C0005910 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C25208 (NCI Thesaurus Property)
    MedicalDictionaryforRegulatoryActivitiesTerminologyIdentifierCode
    Item
    Disease code (mesothelioma)
    float
    C25162 (NCI Thesaurus ValueDomain)
    C0805701 (UMLS 2011AA ValueDomain)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    CL104089 (NCI Metathesaurus ObjectClass)
    C43820 (NCI Thesaurus ValueDomain-2)
    C1140263 (UMLS 2011AA ValueDomain-2)
    Item Group
    Certification Of Eligibility
    Eligibility for trial
    Item
    In the opinion of the investigator, is the patient eligible
    boolean
    C38148 (NCI Thesaurus ValueDomain)
    C1302261 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C25171 (NCI Thesaurus Property)
    Item Group
    Prior Therapy
    Item
    Prior Cancer Therapies (Mark all that apply with an X.)
    text
    C25284 (NCI Thesaurus ValueDomain)
    C1514463 (UMLS CUI-1)
    C25629 (NCI Thesaurus ObjectClass)
    C15368 (NCI Thesaurus ObjectClass-2)
    C25365 (NCI Thesaurus Property)
    Code List
    Prior Cancer Therapies (Mark all that apply with an X.)
    CL Item
    No Previous Exposure To Drug (nos) (No prior therapy)
    CL Item
    Agents Administered To Control The Replication And/or Spread Of Viruses (Anti-retroviral therapy)
    CL Item
    Treatment With An Agent That Prevents Or Impairs The Translation Of The Genetic Message For Production Of A Specific Protein (Antisense)
    CL Item
    High Dose Chemotherapy Combined With Transplantation Of Bone Marrow Cells (Bone marrow transplant)
    CL Item
    Systemic Chemotherapy With A Regimen Containing Multiple Agents (Chemotherapy multiple agents systemic)
    CL Item
    Prior Therapy With Agents That Are Not Known To Cause Damage To Cycling Cells (Chemotherapy non-cytotoxic)
    CL Item
    Non-systemic Chemotherapy Treatment Or Chemotherapy Not Described By Chemotherapy Single Agent Systemic Or Multi-agent Systemic (Chemotherapy (NOS))
    CL Item
    Systemic Chemotherapy With A Single Agent Regimen (Chemotherapy single agent systemic)
    CL Item
    Treatment Of Human Disease By Gene Transfer (Gene transfer)
    CL Item
    Image Directed Local Therapy (Image Directed Local Therapy)
    CL Item
    Cancer Therapy Which Incorporates Hormonal Manipulation (Hormonal therapy)
    CL Item
    Drug And/or Immunotherapy (Drug and/or Immunotherapy)
    CL Item
    Anticancer Treatment With A Live, Replication-competent Virus (Oncolytic virotherapy)
    CL Item
    Targeted Ionizing Radiation Therapy Utilizing Radioactive Implants Or Seeds (Radiation therapy)
    CL Item
    Surgical Procedure, Or Operation, With Therapeutic Intent (Surgery)
    CL Item
    Therapy Nos (Therapy (NOS))
    CL Item
    Substance Or Group Of Substances Administered To Induce The Immune System To Recognize And Destroy Tumors Or Microorganisms (Vaccine)
    CL Item
    Hematopoietic Stem Cell Transplantation (Hematopoietic Stem Cell Transplantation)
    PriorMultipleAgentChemotherapyAdministeredCount
    Item
    Number of regimens (Chemotherapy multiple agents systemic)
    float
    C15632 (NCI Thesaurus ObjectClass)
    C0392920 (UMLS 2011AA ObjectClass)
    C25629 (NCI Thesaurus ObjectClass-2)
    C0332152 (UMLS 2011AA ObjectClass-2)
    C17648 (NCI Thesaurus ObjectClass-3)
    C0439064 (UMLS 2011AA ObjectClass-3)
    C1708 (NCI Thesaurus ObjectClass-4)
    C0450442 (UMLS 2011AA ObjectClass-4)
    C25382 (NCI Thesaurus Property)
    C1521801 (UMLS 2011AA Property)
    C25463 (NCI Thesaurus ValueDomain)
    C0750480 (UMLS 2011AA ValueDomain)
    PriorNon-cytotoxicAgentChemotherapyAdministeredCount
    Item
    Number of regimens (Chemotherapy non-cytotoxic)
    float
    C15632 (NCI Thesaurus ObjectClass)
    C0392920 (UMLS 2011AA ObjectClass)
    C25629 (NCI Thesaurus ObjectClass-2)
    C0332152 (UMLS 2011AA ObjectClass-2)
    C83487 (NCI Thesaurus ObjectClass-3)
    C2827065 (UMLS 2011AA ObjectClass-3)
    C25382 (NCI Thesaurus Property)
    C1521801 (UMLS 2011AA Property)
    C25463 (NCI Thesaurus ValueDomain)
    C0750480 (UMLS 2011AA ValueDomain)
    PriorChemotherapyRegimenNumber
    Item
    Number of regimens (Chemotherapy - NOS)
    text
    C25337 (NCI Thesaurus ValueDomain)
    C0237753 (UMLS 2011AA ValueDomain)
    C15632 (NCI Thesaurus ObjectClass)
    C0392920 (UMLS 2011AA ObjectClass)
    C25629 (NCI Thesaurus ObjectClass-2)
    C0332152 (UMLS 2011AA ObjectClass-2)
    C15697 (NCI Thesaurus Property)
    C0040808 (UMLS 2011AA Property)
    SingleAgentSystemicChemotherapyAdministeredCount
    Item
    Number of regimens (Chemotherapy single agent systemic)
    float
    C25463 (NCI Thesaurus ValueDomain)
    C0750480 (UMLS 2011AA ValueDomain)
    C15756 (NCI Thesaurus ObjectClass)
    C0854619 (UMLS 2011AA ObjectClass)
    C25382 (NCI Thesaurus Property)
    C1521801 (UMLS 2011AA Property)

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