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ID

2754

Descrizione

CALGB-81003 OPEN Registration Worksheet (SPARE Phase Ib) Combination Chemotherapy With or Without Ganitumab in Treating Patients With Previously Untreated Metastatic Pancreatic Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=B5545048-A6BC-B965-E040-BB89AD437802

collegamento

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=B5545048-A6BC-B965-E040-BB89AD437802

Keywords

  1. 19/09/12 19/09/12 -
  2. 09/01/15 09/01/15 - Martin Dugas
  3. 09/01/15 09/01/15 - Martin Dugas
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19 settembre 2012

DOI

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Licenza

Creative Commons BY-NC 3.0 Legacy

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    Pancreatic Cancer NCT01473303 Registration - CALGB-81003 OPEN Registration Worksheet (SPARE Phase Ib) - 3340712v1.0

    Phase IB / Randomized Phase II Study of Folfirinox plus AMG-479 or Placebo in Patients with Previously Untreated, Metastatic Pancreatic Adenocarcinoma

    Protocol Administration
    Descrizione

    Protocol Administration

    Date Informed Consent Signed (MM DD YYYY)
    Descrizione

    InformedConsentFormSignedDate

    Tipo di dati

    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
    HIPAA Authorization Date (MM DD YYYY)
    Descrizione

    PatientSignedDischargeMedicalRecordDate

    Tipo di dati

    date

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

    TreatmentProjectedBeginDate

    Tipo di dati

    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
    Pre-treatment Characteristics
    Descrizione

    Pre-treatment Characteristics

    ECOG Performance Status
    Descrizione

    PerformanceStatusAssessmentEasternCooperativeOncologyGroupScale

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C25664
    UMLS 2011AA ValueDomain
    C0349674
    NCI Thesaurus Property
    C25367
    NCI Thesaurus ValueDomain
    C25491
    UMLS 2011AA ValueDomain
    C1512162
    NCI Thesaurus ObjectClass
    C20641
    UMLS 2011AA ObjectClass
    C1518965
    Height (cm)
    Descrizione

    PatientHeightMeasurement

    Tipo di dati

    double

    Unità di misura
    • cm
    Alias
    NCI Thesaurus ValueDomain
    C25209
    UMLS 2011AA ValueDomain
    C0242485
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C25347
    UMLS 2011AA Property
    C0489786
    cm
    Weight (kg)
    Descrizione

    PatientWeightMeasurement

    Tipo di dati

    double

    Unità di misura
    • Kg
    Alias
    NCI Thesaurus ValueDomain
    C25209
    UMLS 2011AA ValueDomain
    C0242485
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C25208
    UMLS 2011AA Property
    C0043100
    Kg
    Disease code (pancreas)
    Descrizione

    MedicalDictionaryforRegulatoryActivitiesTerminologyIdentifierCode

    Tipo di dati

    double

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

    Certification Of Eligibility

    In the opinion of the investigator, is the patient eligible (for CALGB 61103)
    Descrizione

    PatientEligibilityIndicator

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C25171
    UMLS 2011AA Property
    C0013893
    Protocol Design
    Descrizione

    Protocol Design

    ECOG Performance Status
    Descrizione

    PerformanceStatusAssessmentEasternCooperativeOncologyGroupScale

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C25664
    UMLS 2011AA ValueDomain
    C0349674
    NCI Thesaurus Property
    C25367
    NCI Thesaurus ValueDomain
    C25491
    UMLS 2011AA ValueDomain
    C1512162
    NCI Thesaurus ObjectClass
    C20641
    UMLS 2011AA ObjectClass
    C1518965
    Prior Therapy
    Descrizione

    Prior Therapy

    Prior Cancer Therapies (If patient received prior cancer therapy: Mark an X for each therapy received. For chemotherapies, specify number of regimens received. The number of regimens refers to the number of treatment courses, not the number of cycles received for a course of treatment. For example, a patient who received 3 cycles while on Treatment A and 6 cycles while on Treatment B has received 2 treatment regimens - Treatment A and Treatment B.)
    Descrizione

    PriorTherapyAdministeredType

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    NCI Thesaurus ObjectClass
    C25629
    UMLS 2011AA ObjectClass
    C0332152
    NCI Thesaurus ObjectClass
    C15368
    NCI Thesaurus Property
    C25365
    UMLS 2011AA Property
    C0678257
    Number of regimens (Chemotherapy multiple agents systemic)
    Descrizione

    PriorMultipleAgentChemotherapyAdministeredCount

    Tipo di dati

    double

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

    PriorNon-cytotoxicAgentChemotherapyAdministeredCount

    Tipo di dati

    double

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

    PriorChemotherapyRegimenNumber

    Tipo di dati

    text

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

    SingleAgentSystemicChemotherapyAdministeredCount

    Tipo di dati

    double

    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
    Initial Patient Consent For Specimen Use
    Descrizione

    Initial Patient Consent For Specimen Use

    I choose to take part in the Patient-Reported Outcomes Study and agree to complete the questionnaire once per month (consent question #1 - must be Yes for participation in 71102)
    Descrizione

    PatientAncillaryStudyOneEligibilityDeterminationInd-3

    Tipo di dati

    text

    Alias
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C66832
    UMLS 2011AA Property
    C0205447
    NCI Thesaurus Property
    C25171
    UMLS 2011AA Property
    C0013893
    NCI Thesaurus Property
    C16041
    UMLS 2011AA Property
    C1515980
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    In the opinion of the investigator, is the patient eligible (for CALGB 61103)
    Descrizione

    PatientEligibilityIndicator

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C25171
    UMLS 2011AA Property
    C0013893
    Initial Patient Consent For Specimen Use
    Descrizione

    Initial Patient Consent For Specimen Use

    My coded samples and related coded information may be used to learn about, prevent, find or treat my type of cancer. This may also include research on inherited traits (genes passed on in families) (consent question #2 - must be Yes for participation in 151109 and 61103)
    Descrizione

    PersonSpecimenMalignantNeoplasmResearchConsentInd-2

    Tipo di dati

    text

    Alias
    NCI Thesaurus ObjectClass
    C25190
    UMLS 2011AA ObjectClass
    C0027361
    NCI Thesaurus Property
    C15319
    NCI Thesaurus Property
    C9305
    UMLS 2011AA Property
    C0006826
    NCI Thesaurus Property
    C19157
    UMLS 2011AA Property
    C0370003
    NCI Thesaurus Property
    C25460
    UMLS 2011AA Property
    C1511481
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    My coded samples and related coded information may be kept for use in future research to learn about, prevent, find or treat any type of cancer. This may also include research on inherited traits (genes passed on in families) (consent question #3)
    Descrizione

    SpecimenResearchConsentSharedInd-3

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    NCI Thesaurus Property
    C15319
    NCI Thesaurus ObjectClass
    C19157
    UMLS 2011AA ObjectClass
    C0370003
    NCI Thesaurus Property
    C25460
    UMLS 2011AA Property
    C1511481
    In the opinion of the investigator, is the patient eligible (for CALGB 61103)
    Descrizione

    PatientEligibilityIndicator

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C25171
    UMLS 2011AA Property
    C0013893
    My coded samples and related coded information may be kept for use in future research to learn about, prevent, find or treat other health problems (for example: diabetes, Alzheimer's disease, or heart disease). This may also include research on inherited traits (genes passed on in families) (consent question #4)
    Descrizione

    SouthwestOncologyGroupPatientTissueSpecimenConsentInd-2

    Tipo di dati

    text

    Alias
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus ObjectClass
    C25699
    UMLS 2011AA ObjectClass
    C1519429
    NCI Thesaurus Property
    C12801
    UMLS 2011AA Property
    C0040300
    NCI Thesaurus Property
    C19157
    UMLS 2011AA Property
    C0370003
    NCI Thesaurus Property
    C25460
    UMLS 2011AA Property
    C1511481
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    Someone from my hospital or CALGB may contact me in the future to ask me to take part in more research (consent question #5)
    Descrizione

    PatientAdditionalResearchConsentInd-2

    Tipo di dati

    text

    Alias
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C15319
    NCI Thesaurus Property
    C25406
    UMLS 2011AA Property
    C1524062
    NCI Thesaurus Property
    C25460
    UMLS 2011AA Property
    C1511481
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    Certification Of Eligibility
    Descrizione

    Certification Of Eligibility

    In the opinion of the investigator, is the patient eligible (for CALGB 61103)
    Descrizione

    PatientEligibilityIndicator

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C25171
    UMLS 2011AA Property
    C0013893

    Similar models

    Phase IB / Randomized Phase II Study of Folfirinox plus AMG-479 or Placebo in Patients with Previously Untreated, Metastatic Pancreatic Adenocarcinoma

    Name
    genere
    Description | Question | Decode (Coded Value)
    Tipo di dati
    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)
    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)
    C0025102 (UMLS 2011AA Property)
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    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)
    Item Group
    Pre-treatment Characteristics
    Item
    ECOG Performance Status
    text
    C25664 (NCI Thesaurus ValueDomain)
    C0349674 (UMLS 2011AA ValueDomain)
    C25367 (NCI Thesaurus Property)
    C25491 (NCI Thesaurus ValueDomain)
    C1512162 (UMLS 2011AA ValueDomain)
    C20641 (NCI Thesaurus ObjectClass)
    C1518965 (UMLS 2011AA ObjectClass)
    Code List
    ECOG 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)
    PatientHeightMeasurement
    Item
    Height (cm)
    double
    C25209 (NCI Thesaurus ValueDomain)
    C0242485 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25347 (NCI Thesaurus Property)
    C0489786 (UMLS 2011AA Property)
    PatientWeightMeasurement
    Item
    Weight (kg)
    double
    C25209 (NCI Thesaurus ValueDomain)
    C0242485 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25208 (NCI Thesaurus Property)
    C0043100 (UMLS 2011AA Property)
    Item
    Disease code (pancreas)
    double
    C25162 (NCI Thesaurus ValueDomain)
    C0805701 (UMLS 2011AA ValueDomain)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    CL104089 (NCI Metathesaurus ObjectClass)
    C43820 (NCI Thesaurus ValueDomain)
    C1140263 (UMLS 2011AA ValueDomain)
    Code List
    Disease code (pancreas)
    CL Item
    Pancreas (10052747)
    C12393 (NCI Thesaurus)
    C0030274 (UMLS 2011AA)
    Item Group
    Certification Of Eligibility
    Item
    In the opinion of the investigator, is the patient eligible (for CALGB 61103)
    text
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25171 (NCI Thesaurus Property)
    C0013893 (UMLS 2011AA Property)
    Code List
    In the opinion of the investigator, is the patient eligible (for CALGB 61103)
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    Item Group
    Protocol Design
    Item
    ECOG Performance Status
    text
    C25664 (NCI Thesaurus ValueDomain)
    C0349674 (UMLS 2011AA ValueDomain)
    C25367 (NCI Thesaurus Property)
    C25491 (NCI Thesaurus ValueDomain)
    C1512162 (UMLS 2011AA ValueDomain)
    C20641 (NCI Thesaurus ObjectClass)
    C1518965 (UMLS 2011AA ObjectClass)
    Code List
    ECOG 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)
    Item Group
    Prior Therapy
    Item
    Prior Cancer Therapies (If patient received prior cancer therapy: Mark an X for each therapy received. For chemotherapies, specify number of regimens received. The number of regimens refers to the number of treatment courses, not the number of cycles received for a course of treatment. For example, a patient who received 3 cycles while on Treatment A and 6 cycles while on Treatment B has received 2 treatment regimens - Treatment A and Treatment B.)
    text
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    C25629 (NCI Thesaurus ObjectClass)
    C0332152 (UMLS 2011AA ObjectClass)
    C15368 (NCI Thesaurus ObjectClass)
    C25365 (NCI Thesaurus Property)
    C0678257 (UMLS 2011AA Property)
    Code List
    Prior Cancer Therapies (If patient received prior cancer therapy: Mark an X for each therapy received. For chemotherapies, specify number of regimens received. The number of regimens refers to the number of treatment courses, not the number of cycles received for a course of treatment. For example, a patient who received 3 cycles while on Treatment A and 6 cycles while on Treatment B has received 2 treatment regimens - Treatment A and Treatment B.)
    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)
    double
    C15632 (NCI Thesaurus ObjectClass)
    C0392920 (UMLS 2011AA ObjectClass)
    C25629 (NCI Thesaurus ObjectClass)
    C0332152 (UMLS 2011AA ObjectClass)
    C17648 (NCI Thesaurus ObjectClass)
    C0439064 (UMLS 2011AA ObjectClass)
    C1708 (NCI Thesaurus ObjectClass)
    C0450442 (UMLS 2011AA ObjectClass)
    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)
    double
    C15632 (NCI Thesaurus ObjectClass)
    C0392920 (UMLS 2011AA ObjectClass)
    C25629 (NCI Thesaurus ObjectClass)
    C0332152 (UMLS 2011AA ObjectClass)
    C83487 (NCI Thesaurus ObjectClass)
    C2827065 (UMLS 2011AA ObjectClass)
    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)
    C0332152 (UMLS 2011AA ObjectClass)
    C15697 (NCI Thesaurus Property)
    C0040808 (UMLS 2011AA Property)
    SingleAgentSystemicChemotherapyAdministeredCount
    Item
    Number of regimens (Chemotherapy single agent systemic)
    double
    C25463 (NCI Thesaurus ValueDomain)
    C0750480 (UMLS 2011AA ValueDomain)
    C15756 (NCI Thesaurus ObjectClass)
    C0854619 (UMLS 2011AA ObjectClass)
    C25382 (NCI Thesaurus Property)
    C1521801 (UMLS 2011AA Property)
    Item Group
    Initial Patient Consent For Specimen Use
    Item
    I choose to take part in the Patient-Reported Outcomes Study and agree to complete the questionnaire once per month (consent question #1 - must be Yes for participation in 71102)
    text
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C66832 (NCI Thesaurus Property)
    C0205447 (UMLS 2011AA Property)
    C25171 (NCI Thesaurus Property)
    C0013893 (UMLS 2011AA Property)
    C16041 (NCI Thesaurus Property)
    C1515980 (UMLS 2011AA Property)
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    Code List
    I choose to take part in the Patient-Reported Outcomes Study and agree to complete the questionnaire once per month (consent question #1 - must be Yes for participation in 71102)
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    Item
    In the opinion of the investigator, is the patient eligible (for CALGB 61103)
    text
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25171 (NCI Thesaurus Property)
    C0013893 (UMLS 2011AA Property)
    Code List
    In the opinion of the investigator, is the patient eligible (for CALGB 61103)
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    Item
    My coded samples and related coded information may be used to learn about, prevent, find or treat my type of cancer. This may also include research on inherited traits (genes passed on in families) (consent question #2 - must be Yes for participation in 151109 and 61103)
    text
    C25190 (NCI Thesaurus ObjectClass)
    C0027361 (UMLS 2011AA ObjectClass)
    C15319 (NCI Thesaurus Property)
    C9305 (NCI Thesaurus Property)
    C0006826 (UMLS 2011AA Property)
    C19157 (NCI Thesaurus Property)
    C0370003 (UMLS 2011AA Property)
    C25460 (NCI Thesaurus Property)
    C1511481 (UMLS 2011AA Property)
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    Code List
    My coded samples and related coded information may be used to learn about, prevent, find or treat my type of cancer. This may also include research on inherited traits (genes passed on in families) (consent question #2 - must be Yes for participation in 151109 and 61103)
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    Item
    My coded samples and related coded information may be kept for use in future research to learn about, prevent, find or treat any type of cancer. This may also include research on inherited traits (genes passed on in families) (consent question #3)
    text
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    C15319 (NCI Thesaurus Property)
    C19157 (NCI Thesaurus ObjectClass)
    C0370003 (UMLS 2011AA ObjectClass)
    C25460 (NCI Thesaurus Property)
    C1511481 (UMLS 2011AA Property)
    Code List
    My coded samples and related coded information may be kept for use in future research to learn about, prevent, find or treat any type of cancer. This may also include research on inherited traits (genes passed on in families) (consent question #3)
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    Item
    In the opinion of the investigator, is the patient eligible (for CALGB 61103)
    text
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25171 (NCI Thesaurus Property)
    C0013893 (UMLS 2011AA Property)
    Code List
    In the opinion of the investigator, is the patient eligible (for CALGB 61103)
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    Item
    My coded samples and related coded information may be kept for use in future research to learn about, prevent, find or treat other health problems (for example: diabetes, Alzheimer's disease, or heart disease). This may also include research on inherited traits (genes passed on in families) (consent question #4)
    text
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25699 (NCI Thesaurus ObjectClass)
    C1519429 (UMLS 2011AA ObjectClass)
    C12801 (NCI Thesaurus Property)
    C0040300 (UMLS 2011AA Property)
    C19157 (NCI Thesaurus Property)
    C0370003 (UMLS 2011AA Property)
    C25460 (NCI Thesaurus Property)
    C1511481 (UMLS 2011AA Property)
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    Code List
    My coded samples and related coded information may be kept for use in future research to learn about, prevent, find or treat other health problems (for example: diabetes, Alzheimer's disease, or heart disease). This may also include research on inherited traits (genes passed on in families) (consent question #4)
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    Item
    Someone from my hospital or CALGB may contact me in the future to ask me to take part in more research (consent question #5)
    text
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C15319 (NCI Thesaurus Property)
    C25406 (NCI Thesaurus Property)
    C1524062 (UMLS 2011AA Property)
    C25460 (NCI Thesaurus Property)
    C1511481 (UMLS 2011AA Property)
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    Code List
    Someone from my hospital or CALGB may contact me in the future to ask me to take part in more research (consent question #5)
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    Item Group
    Certification Of Eligibility
    Item
    In the opinion of the investigator, is the patient eligible (for CALGB 61103)
    text
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25171 (NCI Thesaurus Property)
    C0013893 (UMLS 2011AA Property)
    Code List
    In the opinion of the investigator, is the patient eligible (for CALGB 61103)
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)

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