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ID

42998

Description

CALGB 80802 Registration Worksheet Form Sorafenib Tosylate With or Without Doxorubicin Hydrochloride in Treating Patients With Locally Advanced or Metastatic Liver Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=73B6D8AE-48AF-7324-E040-BB89AD43648A

Lien

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=73B6D8AE-48AF-7324-E040-BB89AD43648A

Mots-clés

  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
  4. 17/09/2021 17/09/2021 -
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17 septembre 2021

DOI

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Creative Commons BY-NC 3.0 Legacy

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    Liver Cancer NCT01015833 Registration - CALGB 80802 Registration Worksheet Form - 2940585v1.0

    A Randomized Phase III Trial to Evaluate the Potential Utility of a Genomic Prognostic Model to Identify Stage I Non-Small Cell Lung Cancer NSCLC) Patients as Candidates for Adjuvant Chemotherapy

    Header Module
    Description

    Header Module

    Lead Institution
    Description

    LeadInstitutionName

    Type de données

    text

    Alias
    NCI Thesaurus ObjectClass
    C21541
    UMLS 2011AA ObjectClass
    C0018704
    NCI Thesaurus ObjectClass-2
    C25552
    UMLS 2011AA ObjectClass-2
    C1522538
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    NCI Thesaurus ValueDomain
    C25191
    UMLS 2011AA ValueDomain
    C1547383
    NCI Thesaurus ValueDomain-2
    C21541
    UMLS 2011AA ValueDomain-2
    C0018704
    CALGB Patient ID (Assigned)
    Description

    Trial subject ID CALGB

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C2348585
    NCI Thesaurus ObjectClass
    C16960
    UMLS CUI-2
    C1516238
    NCI Thesaurus Property
    C25364
    NCI Thesaurus Property-2
    C25442
    Institution/Affiliate
    Description

    Institution Name

    Type de données

    text

    Alias
    NCI Thesaurus ObjectClass
    C25454
    UMLS CUI-1
    C1301943
    NCI Thesaurus ObjectClass-2
    C21541
    NCI Thesaurus Property
    C25364
    NCI Thesaurus ValueDomain
    C25191
    NCI Thesaurus ValueDomain-2
    C21541
    Participating Group Name
    Description

    Participating Group

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS CUI-1
    C2347449
    NCI Thesaurus ObjectClass
    C25608
    NCI Thesaurus ObjectClass-2
    C17005
    NCI Thesaurus Property
    C25364
    Physician
    Description

    Investigator Name

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS CUI-1
    C2826892
    NCI Thesaurus Property
    C25364
    NCI Thesaurus ObjectClass
    C17089
    NCI Thesaurus ObjectClass-2
    C25644
    Principal Investigator No.
    Description

    NationalCancerInstitutePrincipalInvestigatorIdentifierNumber

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS 2011AA ValueDomain
    C0237753
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    NCI Thesaurus ObjectClass
    C19202
    UMLS 2011AA ObjectClass
    C1513882
    NCI Thesaurus ObjectClass-2
    C19924
    UMLS 2011AA ObjectClass-2
    C1521895
    Protocol Administration
    Description

    Protocol Administration

    IRB Approval Date (MM DD YYYY)
    Description

    IRB Approval Date

    Type de données

    date

    Alias
    NCI Thesaurus ObjectClass
    C25320
    UMLS CUI-1
    C2346500
    NCI Thesaurus Property
    C16741
    NCI Thesaurus Property-2
    C25425
    NCI Thesaurus ValueDomain
    C25164
    NCI Thesaurus ValueDomain-2
    C25367
    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
    Projected Start Date of Treatment (MM DD YYYY)
    Description

    Treatment Begin Date

    Type de données

    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
    HIPAA Authorization Date (MM DD YYYY)
    Description

    PatientSignedDischargeMedicalRecordDate

    Type de données

    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
    Institution contact
    Description

    InstitutionContactPersonName

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS 2011AA ValueDomain
    C1547383
    NCI Thesaurus ObjectClass
    C21541
    UMLS 2011AA ObjectClass
    C0018704
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    NCI Thesaurus ObjectClass-2
    C25461
    UMLS 2011AA ObjectClass-2
    C0337611
    Phone
    Description

    ContactPersonTelephoneNumber

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS 2011AA ValueDomain
    C0237753
    NCI Thesaurus ObjectClass
    C25190
    UMLS 2011AA ObjectClass
    C0027361
    NCI Thesaurus Property
    C25395
    UMLS 2011AA Property
    C0039457
    NCI Thesaurus ObjectClass-2
    C25461
    UMLS 2011AA ObjectClass-2
    C0337611
    Fax
    Description

    ContactPersonFaxNumber

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS 2011AA ValueDomain
    C0237753
    NCI Thesaurus ObjectClass
    C25190
    UMLS 2011AA ObjectClass
    C0027361
    NCI Thesaurus ObjectClass-2
    C25461
    UMLS 2011AA ObjectClass-2
    C0337611
    NCI Thesaurus Property
    C25210
    UMLS 2011AA Property
    C0085205
    Patient Demographics/pre-treatment Characteristics
    Description

    Patient Demographics/pre-treatment Characteristics

    Patient Initials (Last, First Middle)
    Description

    Patient Initials

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS CUI-1
    C2986440
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25536
    Date of Birth (MM DD YYYY)
    Description

    Patient Birth Date

    Type de données

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS CUI-1
    C0421451
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus ValueDomain-2
    C25367
    NCI Thesaurus Property
    C25155
    Patient Social Security Number
    Description

    PatientPersonSocialSecurityNumber

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS 2011AA ValueDomain
    C0237753
    NCI Thesaurus ObjectClass
    C25190
    UMLS 2011AA ObjectClass
    C0027361
    NCI Thesaurus Property
    C25686
    UMLS 2011AA Property
    C1301821
    Patient Hospital No.
    Description

    Medical Record Number

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C1301894
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25261
    NCI Thesaurus Property-2
    C25198
    Gender
    Description

    Gender

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25372
    UMLS CUI-1
    C0079399
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C17357
    Patient Demographics/pre-treatment Characteristics2
    Description

    Patient Demographics/pre-treatment Characteristics2

    Race (Mark all that apply)
    Description

    Racial Group

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25372
    UMLS CUI-1
    C0034510
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C17049
    Ethnicity (Mark one)
    Description

    Ethnic Group

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25372
    UMLS CUI-1
    C0015031
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C16564
    Performance Status (ECOG/Zubrod scale)
    Description

    ECOG Performance Status

    Type de données

    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)
    Description

    Patient Height

    Type de données

    float

    Unités de mesure
    • cm
    Alias
    NCI Thesaurus ValueDomain
    C25209
    UMLS CUI-1
    C0489786
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25347
    cm
    Weight (kg)
    Description

    Patient Weight

    Type de données

    float

    Unités de mesure
    • Kg
    Alias
    NCI Thesaurus ValueDomain
    C25209
    UMLS CUI-1
    C0005910
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25208
    Kg
    BSA (m^2)
    Description

    Body Surface Area

    Type de données

    float

    Unités de mesure
    • m2
    Alias
    NCI Thesaurus ObjectClass
    C25190
    UMLS CUI-1
    C0005902
    NCI Thesaurus ValueDomain
    C25712
    NCI Thesaurus Property
    C25157
    m2
    Method of Payment (USA only Mark one)
    Description

    PatientPaymentType

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C25371
    UMLS 2011AA Property
    C0680264
    Patient Demographics/pre-treatment Characteristics3
    Description

    Patient Demographics/pre-treatment Characteristics3

    Disease
    Description

    DiseaseDescriptionText

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25704
    UMLS 2011AA ValueDomain
    C1527021
    NCI Thesaurus ObjectClass
    C2991
    UMLS 2011AA ObjectClass
    C0012634
    NCI Thesaurus Property
    C25365
    UMLS 2011AA Property
    C0678257
    Patient Zip Code
    Description

    PatientAddressPostalCode

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25162
    UMLS 2011AA ValueDomain
    C0805701
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C25407
    UMLS 2011AA Property
    C1442065
    Country of Residence (If not USA)
    Description

    Country of current residence

    Type de données

    text

    Alias
    NCI Thesaurus ObjectClass
    C16960
    UMLS CUI-1
    C3258975
    NCI Thesaurus ValueDomain
    C25464
    NCI Thesaurus Property
    C25407
    NCI Thesaurus ValueDomain-2
    C42614
    Certification Of Eligibility And Protocol Design
    Description

    Certification Of Eligibility And Protocol Design

    In the opinion of the investigator, is the patient eligible?
    Description

    Eligibility for trial

    Type de données

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS CUI-1
    C1302261
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25171
    Protocol Design
    Description

    Protocol Design

    Hepatitis status
    Description

    HepatitisDescriptionStatus

    Type de données

    text

    Alias
    NCI Thesaurus ObjectClass
    C3095
    UMLS 2011AA ObjectClass
    C0019158
    NCI Thesaurus ValueDomain
    C25688
    UMLS 2011AA ValueDomain
    C0449438
    NCI Thesaurus Property
    C25365
    UMLS 2011AA Property
    C0678257
    Extent of disease
    Description

    DiseaseInvolvementType

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    NCI Thesaurus ObjectClass
    C2991
    UMLS 2011AA ObjectClass
    C0012634
    NCI Thesaurus Property
    C25548
    UMLS 2011AA Property
    C1314939
    Assigned Treatment Arm
    Description

    Protocol Treatment Arm

    Type de données

    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
    Protocol Design
    Description

    Protocol Design

    Did the patient agree to participate in the CT imaging study
    Description

    PersonDiagnosticImagingCurrentClinicalTrialConsentIndicator

    Type de données

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C25190
    UMLS 2011AA ObjectClass
    C0027361
    NCI Thesaurus Property
    C16502
    UMLS 2011AA Property
    C0011923
    NCI Thesaurus Property-2
    C25471
    UMLS 2011AA Property-2
    C0521116
    NCI Thesaurus Property-3
    C15207
    NCI Thesaurus Property-4
    C25460
    UMLS 2011AA Property-3
    C1511481
    NCI Thesaurus ValueDomain
    C25180
    UMLS 2011AA ValueDomain
    C1522602
    Patient's Initial Consent given for specimen use for research on the patient's cancer
    Description

    TissueSpecimenMalignantNeoplasmRelatedResearchConsentInd-3

    Type de données

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C12801
    UMLS 2011AA ObjectClass
    C0040300
    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
    Patient's initial consent given for blood specimen use for genetic research on patient's cancer?
    Description

    BloodSpecimenRelatedGeneticResearchConsentInd-2

    Type de données

    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
    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 kept for future use in research to learn about, prevent, or treat cancer
    Description

    PersonSpecimenMalignantNeoplasmResearchConsentInd-2

    Type de données

    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 use for research unrelated to the patient's cancer?
    Description

    BloodTissueSpecimenOtherDiseasesandDisordersResearchConsentInd-3

    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
    C2991
    UMLS 2011AA Property-2
    C0012634
    NCI Thesaurus Property-4
    C25460
    UMLS 2011AA Property-3
    C1511481
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    Patient's initial consent given for further contact regarding specimen?
    Description

    Permission to contact Patient

    Type de données

    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
    Registration Information
    Description

    Registration Information

    CALGB Patient ID (Assigned)
    Description

    Trial subject ID CALGB

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C2348585
    NCI Thesaurus ObjectClass
    C16960
    UMLS CUI-2
    C1516238
    NCI Thesaurus Property
    C25364
    NCI Thesaurus Property-2
    C25442
    Registration Date (MM DD YYYY)
    Description

    PatientRegistrationDate

    Type de données

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus ValueDomain-2
    C25367
    NCI Thesaurus Property
    C25646
    UMLS 2011AA Property
    C1514821
    Participating Group Patient ID (Assigned)
    Description

    Trial subject ID Participating Group

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C2348585
    NCI Thesaurus ObjectClass
    C16960
    UMLS CUI-2
    C2347449
    NCI Thesaurus Property
    C25608
    NCI Thesaurus Property-2
    C25364
    Registrar's Signature
    Description

    RegisteringPersonIdentifierSignatureName

    Type de données

    text

    Alias
    NCI Thesaurus ObjectClass
    C25190
    UMLS 2011AA ObjectClass
    C0027361
    NCI Thesaurus ObjectClass-2
    C25645
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    NCI Thesaurus ValueDomain
    C25191
    UMLS 2011AA ValueDomain
    C1547383
    NCI Thesaurus ValueDomain-2
    C25678
    UMLS 2011AA ValueDomain-2
    C1519316
    Notes:
    Description

    Notes:

    CRA Name
    Description

    ClinicalResearchAssociateResponsiblePersonName

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS 2011AA ValueDomain
    C1547383
    NCI Thesaurus ObjectClass
    C25657
    UMLS 2011AA ObjectClass
    C1273518
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    NCI Thesaurus ObjectClass-2
    C25465
    UMLS 2011AA ObjectClass-2
    C1516627
    CRA e-mail
    Description

    ClinicalResearchAssociatePersonEmailAddressText

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25704
    UMLS 2011AA ValueDomain
    C1527021
    NCI Thesaurus ObjectClass
    C25190
    UMLS 2011AA ObjectClass
    C0027361
    NCI Thesaurus ObjectClass-2
    C25465
    UMLS 2011AA ObjectClass-2
    C1516627
    NCI Thesaurus Property
    C42775
    UMLS 2011AA Property
    C1705961
    CRA Phone
    Description

    ClinicalResearchAssociatePersonTelephoneNumber

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS 2011AA ValueDomain
    C0237753
    NCI Thesaurus ObjectClass
    C25190
    UMLS 2011AA ObjectClass
    C0027361
    NCI Thesaurus Property
    C25395
    UMLS 2011AA Property
    C0039457
    NCI Thesaurus ObjectClass-2
    C25465
    UMLS 2011AA ObjectClass-2
    C1516627

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    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    Alias
    Item Group
    Header Module
    LeadInstitutionName
    Item
    Lead Institution
    text
    C21541 (NCI Thesaurus ObjectClass)
    C0018704 (UMLS 2011AA ObjectClass)
    C25552 (NCI Thesaurus ObjectClass-2)
    C1522538 (UMLS 2011AA ObjectClass-2)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    C25191 (NCI Thesaurus ValueDomain)
    C1547383 (UMLS 2011AA ValueDomain)
    C21541 (NCI Thesaurus ValueDomain-2)
    C0018704 (UMLS 2011AA ValueDomain-2)
    Trial subject ID CALGB
    Item
    CALGB Patient ID (Assigned)
    text
    C25337 (NCI Thesaurus ValueDomain)
    C2348585 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C1516238 (UMLS CUI-2)
    C25364 (NCI Thesaurus Property)
    C25442 (NCI Thesaurus Property-2)
    Institution Name
    Item
    Institution/Affiliate
    text
    C25454 (NCI Thesaurus ObjectClass)
    C1301943 (UMLS CUI-1)
    C21541 (NCI Thesaurus ObjectClass-2)
    C25364 (NCI Thesaurus Property)
    C25191 (NCI Thesaurus ValueDomain)
    C21541 (NCI Thesaurus ValueDomain-2)
    Participating Group
    Item
    Participating Group Name
    text
    C25191 (NCI Thesaurus ValueDomain)
    C2347449 (UMLS CUI-1)
    C25608 (NCI Thesaurus ObjectClass)
    C17005 (NCI Thesaurus ObjectClass-2)
    C25364 (NCI Thesaurus Property)
    Investigator Name
    Item
    Physician
    text
    C25191 (NCI Thesaurus ValueDomain)
    C2826892 (UMLS CUI-1)
    C25364 (NCI Thesaurus Property)
    C17089 (NCI Thesaurus ObjectClass)
    C25644 (NCI Thesaurus ObjectClass-2)
    NationalCancerInstitutePrincipalInvestigatorIdentifierNumber
    Item
    Principal Investigator No.
    text
    C25337 (NCI Thesaurus ValueDomain)
    C0237753 (UMLS 2011AA ValueDomain)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    C19202 (NCI Thesaurus ObjectClass)
    C1513882 (UMLS 2011AA ObjectClass)
    C19924 (NCI Thesaurus ObjectClass-2)
    C1521895 (UMLS 2011AA ObjectClass-2)
    Item Group
    Protocol Administration
    IRB Approval Date
    Item
    IRB Approval Date (MM DD YYYY)
    date
    C25320 (NCI Thesaurus ObjectClass)
    C2346500 (UMLS CUI-1)
    C16741 (NCI Thesaurus Property)
    C25425 (NCI Thesaurus Property-2)
    C25164 (NCI Thesaurus ValueDomain)
    C25367 (NCI Thesaurus ValueDomain-2)
    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)
    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)
    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)
    InstitutionContactPersonName
    Item
    Institution contact
    text
    C25191 (NCI Thesaurus ValueDomain)
    C1547383 (UMLS 2011AA ValueDomain)
    C21541 (NCI Thesaurus ObjectClass)
    C0018704 (UMLS 2011AA ObjectClass)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    C25461 (NCI Thesaurus ObjectClass-2)
    C0337611 (UMLS 2011AA ObjectClass-2)
    ContactPersonTelephoneNumber
    Item
    Phone
    text
    C25337 (NCI Thesaurus ValueDomain)
    C0237753 (UMLS 2011AA ValueDomain)
    C25190 (NCI Thesaurus ObjectClass)
    C0027361 (UMLS 2011AA ObjectClass)
    C25395 (NCI Thesaurus Property)
    C0039457 (UMLS 2011AA Property)
    C25461 (NCI Thesaurus ObjectClass-2)
    C0337611 (UMLS 2011AA ObjectClass-2)
    ContactPersonFaxNumber
    Item
    Fax
    text
    C25337 (NCI Thesaurus ValueDomain)
    C0237753 (UMLS 2011AA ValueDomain)
    C25190 (NCI Thesaurus ObjectClass)
    C0027361 (UMLS 2011AA ObjectClass)
    C25461 (NCI Thesaurus ObjectClass-2)
    C0337611 (UMLS 2011AA ObjectClass-2)
    C25210 (NCI Thesaurus Property)
    C0085205 (UMLS 2011AA Property)
    Item Group
    Patient Demographics/pre-treatment Characteristics
    Patient Initials
    Item
    Patient Initials (Last, First Middle)
    text
    C25191 (NCI Thesaurus ValueDomain)
    C2986440 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C25536 (NCI Thesaurus Property)
    Patient Birth Date
    Item
    Date of Birth (MM DD YYYY)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0421451 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C25367 (NCI Thesaurus ValueDomain-2)
    C25155 (NCI Thesaurus Property)
    PatientPersonSocialSecurityNumber
    Item
    Patient Social Security Number
    text
    C25337 (NCI Thesaurus ValueDomain)
    C0237753 (UMLS 2011AA ValueDomain)
    C25190 (NCI Thesaurus ObjectClass)
    C0027361 (UMLS 2011AA ObjectClass)
    C25686 (NCI Thesaurus Property)
    C1301821 (UMLS 2011AA Property)
    Medical Record Number
    Item
    Patient Hospital No.
    text
    C25337 (NCI Thesaurus ValueDomain)
    C1301894 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C25261 (NCI Thesaurus Property)
    C25198 (NCI Thesaurus Property-2)
    Item
    Gender
    text
    C25372 (NCI Thesaurus ValueDomain)
    C0079399 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C17357 (NCI Thesaurus Property)
    Code List
    Gender
    CL Item
    Male (MALE)
    C46109 (NCI Thesaurus)
    C1706180 (UMLS 2011AA)
    CL Item
    Female (FEMALE)
    C46110 (NCI Thesaurus)
    C0086287 (UMLS 2011AA)
    Item Group
    Patient Demographics/pre-treatment Characteristics2
    Item
    Race (Mark all that apply)
    text
    C25372 (NCI Thesaurus ValueDomain)
    C0034510 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C17049 (NCI Thesaurus Property)
    Code List
    Race (Mark all that apply)
    CL Item
    A Person Having Origins In Any Of The Original Peoples Of North And South America (including Central America), And Who Maintains Tribal Affiliation Or Community Attachment. (American Indian or Alaska Native)
    C41259 (NCI Thesaurus)
    C1515945 (UMLS 2011AA)
    CL Item
    A Person Having Origins In Any Of The Original Peoples Of The Far East, Southeast Asia, Or The Indian Subcontinent Including, For Example, Cambodia, China, India, Japan, Korea, Malaysia, Pakistan, The Philippine Islands, Thailand, And Vietnam. (Asian)
    C41260 (NCI Thesaurus)
    C0078988 (UMLS 2011AA)
    CL Item
    A Person Having Origins In Any Of The Black Racial Groups Of Africa. Terms Such As "haitian" Or "negro" Can Be Used In Addition To "black Or African American." (Black or African American)
    C16352 (NCI Thesaurus)
    C0085756 (UMLS 2011AA)
    CL Item
    A Person Having Origins In Any Of The Original Peoples Of Hawaii, Guam, Samoa, Or Other Pacific Islands. (Native Hawaiian or other Pacific Islander)
    C41219 (NCI Thesaurus)
    C1513907 (UMLS 2011AA)
    CL Item
    Could Not Be Determined Or Unsure (Unknown)
    C17998 (NCI Thesaurus)
    C0439673 (UMLS 2011AA)
    CL Item
    A Person Having Origins In Any Of The Original Peoples Of Europe, The Middle East, Or North Africa. (White)
    C41261 (NCI Thesaurus)
    C0007457 (UMLS 2011AA)
    Item
    Ethnicity (Mark one)
    text
    C25372 (NCI Thesaurus ValueDomain)
    C0015031 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C16564 (NCI Thesaurus Property)
    Code List
    Ethnicity (Mark one)
    CL Item
    A Person Of Mexican, Puerto Rican, Cuban, Central Or South American Or Other Spanish Culture Or Origin, Regardless Of Race. (Hispanic or Latino)
    C17459 (NCI Thesaurus)
    C0086409 (UMLS 2011AA)
    CL Item
    A Person Not Meeting The Definition For Hispanic Or Latino. (Not Hispanic or Latino)
    C41222 (NCI Thesaurus)
    C1518424 (UMLS 2011AA)
    CL Item
    Could Not Be Determined Or Unsure (Unknown)
    C17998 (NCI Thesaurus)
    C0439673 (UMLS 2011AA)
    Item
    Performance Status (ECOG/Zubrod scale)
    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 (ECOG/Zubrod scale)
    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)
    CL Item
    Ambulatory And Capable Of All Selfcare But Unable To Carry Out Any Work Activities. Up And About More Than 50% Of Waking Hours. (2)
    CL Item
    Capable Of Only Limited Selfcare, Confined To Bed Or Chair More Than 50% Of Waking Hours. (3)
    CL Item
    Completely Disabled. Cannot Carry On Any Selfcare. Totally Confined To Bed Or Chair. (4)
    CL Item
    Dead (5)
    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)
    Body Surface Area
    Item
    BSA (m^2)
    float
    C25190 (NCI Thesaurus ObjectClass)
    C0005902 (UMLS CUI-1)
    C25712 (NCI Thesaurus ValueDomain)
    C25157 (NCI Thesaurus Property)
    Item
    Method of Payment (USA only Mark one)
    text
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25371 (NCI Thesaurus Property)
    C0680264 (UMLS 2011AA Property)
    Code List
    Method of Payment (USA only Mark one)
    CL Item
    Medicaid (Medicaid)
    C0025071 (NCI Metathesaurus)
    CL Item
    Medicaid And Medicare (Medicaid and Medicare)
    CL Item
    Medicare (Medicare)
    C16665 (NCI Thesaurus)
    C0018717 (UMLS 2011AA)
    CL Item
    Medicare And Private Insurance (Medicare and Private Insurance)
    CL Item
    Military Sponsored (including Champus & Tricare) (Military Sponsored (including CHAMPUS & TRICARE))
    CL Item
    No Means Of Payment (no Insurance) (No means of payment (no insurance))
    CL Item
    Other (Other)
    C17649 (NCI Thesaurus)
    C0205394 (UMLS 2011AA)
    CL Item
    Private Insurance (Private Insurance)
    CL Item
    Self Pay (no Insurance) (Self Pay (No Insurance))
    CL Item
    Unknown (Unknown)
    C17998 (NCI Thesaurus)
    C0439673 (UMLS 2011AA)
    CL Item
    Veterans Sponsored (Veterans Sponsored)
    Item Group
    Patient Demographics/pre-treatment Characteristics3
    DiseaseDescriptionText
    Item
    Disease
    text
    C25704 (NCI Thesaurus ValueDomain)
    C1527021 (UMLS 2011AA ValueDomain)
    C2991 (NCI Thesaurus ObjectClass)
    C0012634 (UMLS 2011AA ObjectClass)
    C25365 (NCI Thesaurus Property)
    C0678257 (UMLS 2011AA Property)
    PatientAddressPostalCode
    Item
    Patient Zip Code
    text
    C25162 (NCI Thesaurus ValueDomain)
    C0805701 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25407 (NCI Thesaurus Property)
    C1442065 (UMLS 2011AA Property)
    Country of current residence
    Item
    Country of Residence (If not USA)
    text
    C16960 (NCI Thesaurus ObjectClass)
    C3258975 (UMLS CUI-1)
    C25464 (NCI Thesaurus ValueDomain)
    C25407 (NCI Thesaurus Property)
    C42614 (NCI Thesaurus ValueDomain-2)
    Item Group
    Certification Of Eligibility And Protocol Design
    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
    Protocol Design
    Item
    Hepatitis status
    text
    C3095 (NCI Thesaurus ObjectClass)
    C0019158 (UMLS 2011AA ObjectClass)
    C25688 (NCI Thesaurus ValueDomain)
    C0449438 (UMLS 2011AA ValueDomain)
    C25365 (NCI Thesaurus Property)
    C0678257 (UMLS 2011AA Property)
    Code List
    Hepatitis status
    CL Item
    No Hepatitis (No hepatitis)
    CL Item
    Hepatitis B (Hepatitis B)
    C3097 (NCI Thesaurus)
    C0019163 (UMLS 2011AA)
    CL Item
    Hepatitis C (Hepatitis C)
    C3098 (NCI Thesaurus)
    C0019196 (UMLS 2011AA)
    CL Item
    Hepatitis B And C (Hepatitis B and C)
    Item
    Extent of disease
    text
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    C2991 (NCI Thesaurus ObjectClass)
    C0012634 (UMLS 2011AA ObjectClass)
    C25548 (NCI Thesaurus Property)
    C1314939 (UMLS 2011AA Property)
    Code List
    Extent of disease
    CL Item
    Locally Advanced (Locally advanced)
    CL Item
    Metastatic (Metastatic)
    C14174 (NCI Thesaurus)
    C0036525 (UMLS 2011AA)
    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
    Arm A: Doxorubicin Plus Sorafenib (Arm A: Doxorubicin plus Sorafenib)
    CL Item
    Arm B: Sorafenib (Arm B: Sorafenib)
    Item Group
    Protocol Design
    PersonDiagnosticImagingCurrentClinicalTrialConsentIndicator
    Item
    Did the patient agree to participate in the CT imaging study
    boolean
    C25190 (NCI Thesaurus ObjectClass)
    C0027361 (UMLS 2011AA ObjectClass)
    C16502 (NCI Thesaurus Property)
    C0011923 (UMLS 2011AA Property)
    C25471 (NCI Thesaurus Property-2)
    C0521116 (UMLS 2011AA Property-2)
    C15207 (NCI Thesaurus Property-3)
    C25460 (NCI Thesaurus Property-4)
    C1511481 (UMLS 2011AA Property-3)
    C25180 (NCI Thesaurus ValueDomain)
    C1522602 (UMLS 2011AA ValueDomain)
    TissueSpecimenMalignantNeoplasmRelatedResearchConsentInd-3
    Item
    Patient's Initial Consent given for specimen use for research on the patient's cancer
    boolean
    C12801 (NCI Thesaurus ObjectClass)
    C0040300 (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)
    BloodSpecimenRelatedGeneticResearchConsentInd-2
    Item
    Patient's initial consent given for blood specimen use for genetic research on patient's cancer?
    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)
    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)
    PersonSpecimenMalignantNeoplasmResearchConsentInd-2
    Item
    Patient's Initial Consent given for specimen kept for future use in research to learn about, prevent, or treat cancer
    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)
    BloodTissueSpecimenOtherDiseasesandDisordersResearchConsentInd-3
    Item
    Patient's Initial Consent given for specimen use for research unrelated to the patient's cancer?
    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)
    C2991 (NCI Thesaurus Property-3)
    C0012634 (UMLS 2011AA Property-2)
    C25460 (NCI Thesaurus Property-4)
    C1511481 (UMLS 2011AA Property-3)
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    Permission to contact Patient
    Item
    Patient's initial consent given for further contact regarding specimen?
    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)
    Item Group
    Registration Information
    Trial subject ID CALGB
    Item
    CALGB Patient ID (Assigned)
    text
    C25337 (NCI Thesaurus ValueDomain)
    C2348585 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C1516238 (UMLS CUI-2)
    C25364 (NCI Thesaurus Property)
    C25442 (NCI Thesaurus Property-2)
    PatientRegistrationDate
    Item
    Registration Date (MM DD YYYY)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25367 (NCI Thesaurus ValueDomain-2)
    C25646 (NCI Thesaurus Property)
    C1514821 (UMLS 2011AA Property)
    Trial subject ID Participating Group
    Item
    Participating Group Patient ID (Assigned)
    text
    C25337 (NCI Thesaurus ValueDomain)
    C2348585 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C2347449 (UMLS CUI-2)
    C25608 (NCI Thesaurus Property)
    C25364 (NCI Thesaurus Property-2)
    RegisteringPersonIdentifierSignatureName
    Item
    Registrar's Signature
    text
    C25190 (NCI Thesaurus ObjectClass)
    C0027361 (UMLS 2011AA ObjectClass)
    C25645 (NCI Thesaurus ObjectClass-2)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    C25191 (NCI Thesaurus ValueDomain)
    C1547383 (UMLS 2011AA ValueDomain)
    C25678 (NCI Thesaurus ValueDomain-2)
    C1519316 (UMLS 2011AA ValueDomain-2)
    Item Group
    Notes:
    ClinicalResearchAssociateResponsiblePersonName
    Item
    CRA Name
    text
    C25191 (NCI Thesaurus ValueDomain)
    C1547383 (UMLS 2011AA ValueDomain)
    C25657 (NCI Thesaurus ObjectClass)
    C1273518 (UMLS 2011AA ObjectClass)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    C25465 (NCI Thesaurus ObjectClass-2)
    C1516627 (UMLS 2011AA ObjectClass-2)
    ClinicalResearchAssociatePersonEmailAddressText
    Item
    CRA e-mail
    text
    C25704 (NCI Thesaurus ValueDomain)
    C1527021 (UMLS 2011AA ValueDomain)
    C25190 (NCI Thesaurus ObjectClass)
    C0027361 (UMLS 2011AA ObjectClass)
    C25465 (NCI Thesaurus ObjectClass-2)
    C1516627 (UMLS 2011AA ObjectClass-2)
    C42775 (NCI Thesaurus Property)
    C1705961 (UMLS 2011AA Property)
    ClinicalResearchAssociatePersonTelephoneNumber
    Item
    CRA Phone
    text
    C25337 (NCI Thesaurus ValueDomain)
    C0237753 (UMLS 2011AA ValueDomain)
    C25190 (NCI Thesaurus ObjectClass)
    C0027361 (UMLS 2011AA ObjectClass)
    C25395 (NCI Thesaurus Property)
    C0039457 (UMLS 2011AA Property)
    C25465 (NCI Thesaurus ObjectClass-2)
    C1516627 (UMLS 2011AA ObjectClass-2)

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