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42991

Description

Z6051 - OPEN Enrollment Form Laparoscopic-Assisted Resection or Open Resection in Treating Patients With Stage IIA, Stage IIIA, or Stage IIIB Rectal Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=7AB13387-079D-04A4-E040-BB89AD4319A7

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=7AB13387-079D-04A4-E040-BB89AD4319A7

Keywords

  1. 8/27/12 8/27/12 -
  2. 1/9/15 1/9/15 - Martin Dugas
  3. 1/9/15 1/9/15 - Martin Dugas
  4. 9/17/21 9/17/21 -
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September 17, 2021

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Creative Commons BY-NC 3.0 Legacy

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    Colorectal Cancer NCT00726622 Registration - Z6051 - OPEN Enrollment Form - 2967118v1.0

    (Web site address for OPEN portal: http://open.ctsu.org/open/)

    Header Module
    Description

    Header Module

    Institution CTEP ID
    Description

    TreatingInstitutionTextCode

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25162
    UMLS 2011AA ValueDomain
    C0805701
    NCI Thesaurus ObjectClass
    C25705
    UMLS 2011AA ObjectClass
    C1522326
    NCI Thesaurus ObjectClass-2
    C19992
    UMLS 2011AA ObjectClass-2
    C1516607
    NCI Metathesaurus Property
    CL281747
    Institution Name
    Description

    Institution Name

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS CUI-1
    C1301943
    NCI Thesaurus ObjectClass
    C21541
    NCI Thesaurus ValueDomain-2
    C21541
    NCI Thesaurus Property
    C25364
    Protocol Number
    Description

    Protocol ID ACOSOG

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C3274381
    NCI Thesaurus ObjectClass
    C25320
    UMLS CUI-2
    C1515944
    NCI Thesaurus Property
    C25364
    NCI Thesaurus Property-2
    C19712
    Protocol Title
    Description

    Protocol Title

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS CUI-1
    C2986303
    NCI Thesaurus ObjectClass
    C25320
    NCI Thesaurus Property
    C42774
    Registration Step
    Description

    Registration Number

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C1514821
    NCI Thesaurus ObjectClass
    C25646
    UMLS CUI-2
    C0237753
    NCI Thesaurus Property
    C16154
    NCI Thesaurus ValueDomain-2
    C16154
    Treating Investigator (Add persons associated with this enrollment)
    Description

    TreatingPhysicianOrParticipatingInvestigatorName

    Data type

    text

    Alias
    NCI Thesaurus ObjectClass
    C25608
    UMLS 2011AA ObjectClass
    C0679823
    NCI Thesaurus ObjectClass-2
    C37998
    UMLS 2011AA ObjectClass-2
    C1518602
    NCI Thesaurus ObjectClass-3
    C51883
    UMLS 2011AA ObjectClass-3
    C1710470
    NCI Thesaurus ObjectClass-4
    C25936
    UMLS 2011AA ObjectClass-4
    C0035173
    NCI Thesaurus Property
    C25191
    UMLS 2011AA Property
    C1547383
    NCI Thesaurus ValueDomain
    C25191
    UMLS 2011AA ValueDomain
    C1547383
    Specify Credits
    Description

    Specify Credits

    Participating Group Code (Credit Specify Cooperative Group to receive enrollment credit)
    Description

    ParticipatingGroupIdentifierCode

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25162
    UMLS 2011AA ValueDomain
    C0805701
    NCI Thesaurus ObjectClass
    C25608
    UMLS 2011AA ObjectClass
    C0679823
    NCI Thesaurus ObjectClass-2
    C17005
    UMLS 2011AA ObjectClass-2
    C1257890
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    Other Group Investigator Name (Credit Note: The Credit Investigator must be affiliated with the credited Cooperative Group and will be accountable for the patient and the site's responsibilities during a Cooperative Group Audit)
    Description

    OtherGroupInvestigatorIdentifierName

    Data type

    text

    Alias
    NCI Thesaurus ObjectClass
    C17649
    UMLS 2011AA ObjectClass
    C0205394
    NCI Thesaurus ObjectClass-2
    C25936
    UMLS 2011AA ObjectClass-2
    C0035173
    NCI Thesaurus ObjectClass-3
    C43359
    UMLS 2011AA ObjectClass-3
    C0441833
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    NCI Thesaurus ValueDomain
    C25191
    UMLS 2011AA ValueDomain
    C1547383
    Comments (Enter case notes optional)
    Description

    Research Comments

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25704
    UMLS CUI-1
    C0947611
    NCI Thesaurus ObjectClass
    C15319
    NCI Thesaurus Property
    C25393
    Patient Information
    Description

    Patient Information

    Date of Birth (month day year)
    Description

    PersonBirthDate

    Data type

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ObjectClass
    C25190
    UMLS 2011AA ObjectClass
    C0027361
    NCI Thesaurus Property
    C25155
    UMLS 2011AA Property
    C0005615
    Gender of a Person
    Description

    PersonGenderTextType

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    NCI Thesaurus ObjectClass
    C25190
    UMLS 2011AA ObjectClass
    C0027361
    NCI Thesaurus Property
    C17357
    UMLS 2011AA Property
    C0079399
    Ethnicity
    Description

    EthnicGroupCategoryText

    Data type

    text

    Alias
    NCI Thesaurus Property
    C25372
    UMLS 2011AA Property
    C0683312
    NCI Thesaurus ValueDomain
    C25372
    UMLS 2011AA ValueDomain
    C0683312
    NCI Thesaurus ObjectClass
    C16564
    UMLS 2011AA ObjectClass
    C0015031
    Country of Residence
    Description

    PersonAddressCountryName

    Data type

    text

    Alias
    NCI Thesaurus ObjectClass
    C25190
    UMLS 2011AA ObjectClass
    C0027361
    NCI Thesaurus ValueDomain
    C25464
    UMLS 2011AA ValueDomain
    C0454664
    NCI Thesaurus Property
    C25407
    UMLS 2011AA Property
    C1442065
    NCI Thesaurus ValueDomain-2
    C42614
    UMLS 2011AA ValueDomain-2
    C0027365
    Zip code
    Description

    PersonAddressPostalCode

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25162
    UMLS 2011AA ValueDomain
    C0805701
    NCI Thesaurus ObjectClass
    C25190
    UMLS 2011AA ObjectClass
    C0027361
    NCI Thesaurus Property
    C25407
    UMLS 2011AA Property
    C1442065
    Race
    Description

    Racial Group

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25372
    UMLS CUI-1
    C0034510
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C17049
    Method of Payment
    Description

    PatientPaymentType

    Data type

    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
    General Information
    Description

    General Information

    Pt ID# (Local Patient Identifier)
    Description

    PatientIdentifier

    Data type

    text

    Alias
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    NCI Thesaurus ValueDomain
    C25364
    UMLS 2011AA ValueDomain
    C0600091
    Last (initial)
    Description

    Patient Initials Last

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS CUI-1
    C2986440
    NCI Thesaurus ObjectClass
    C16960
    UMLS CUI-2
    C1517741
    NCI Thesaurus Property
    C25536
    NCI Thesaurus Property-2
    C25551
    First (initial)
    Description

    Patient Initials First

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS CUI-1
    C2986440
    NCI Thesaurus ObjectClass
    C16960
    UMLS CUI-2
    C0205435
    NCI Thesaurus Property
    C25536
    NCI Thesaurus Property-2
    C25509
    Middle (initial optional)
    Description

    PatientMiddleInitialsName

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS 2011AA ValueDomain
    C1547383
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C25536
    UMLS 2011AA Property
    C1555582
    NCI Thesaurus Property-2
    C25569
    UMLS 2011AA Property-2
    C0444598
    E-mail (for Registration Confirmation)
    Description

    ResponsiblePersonE-mailAddressText

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25704
    UMLS 2011AA ValueDomain
    C1527021
    NCI Thesaurus ObjectClass
    C25657
    UMLS 2011AA ObjectClass
    C1273518
    NCI Thesaurus Property
    C42775
    UMLS 2011AA Property
    C1705961
    Date Informed Consent Signed (month day year)
    Description

    InformedConsentFormSignedDate

    Data type

    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
    Was HIPAA Authorization included in Study Informed Consent (mark one)
    Description

    HealthInsurancePortabilityandAccountabilityActAuthorizationIndicator

    Data type

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C25180
    UMLS 2011AA ValueDomain
    C1522602
    NCI Thesaurus ObjectClass
    C62504
    UMLS 2011AA ObjectClass
    C0600593
    NCI Thesaurus Property
    C41192
    UMLS 2011AA Property
    C1524004
    HIPAA authorization date (If no, month day year)
    Description

    HealthInsurancePortabilityandAccountabilityActTissueDonorAuthorizationDate

    Data type

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus Property
    C25168
    UMLS 2011AA Property
    C0040288
    NCI Thesaurus ObjectClass
    C62504
    UMLS 2011AA ObjectClass
    C0600593
    NCI Thesaurus Property-2
    C41192
    UMLS 2011AA Property-2
    C1524004
    Stratification Factors
    Description

    Stratification Factors

    Site of primary tumor
    Description

    RectalCarcinomaLocationAnatomicSite

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C13717
    UMLS 2011AA ValueDomain
    C1515974
    NCI Thesaurus Property
    C25341
    UMLS 2011AA Property
    C0450429
    NCI Thesaurus ObjectClass
    C9382
    UMLS 2011AA ObjectClass
    C0007113
    Planned operative procedure
    Description

    ColorectalSurgicalProcedurePlannedColorectalSurgicalProcedurePerformedType

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    NCI Thesaurus ObjectClass
    C13363
    UMLS 2011AA ObjectClass
    C0555952
    NCI Thesaurus ObjectClass-2
    C15329
    UMLS 2011AA ObjectClass-2
    C0543467
    NCI Thesaurus Property
    C25619
    UMLS 2011AA Property
    C1301732
    Eligibility Criteria
    Description

    Eligibility Criteria

    Histologic diagnosis of adenocarcinoma of the rectum (<= 12cm from the anal verge)
    Description

    RectalCarcinomaAdenocarcinomaHistologyDiagnosisInd-2

    Data type

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C9382
    UMLS 2011AA ObjectClass
    C0007113
    NCI Thesaurus Property
    C16681
    UMLS 2011AA Property
    C0019638
    NCI Thesaurus Property-2
    C2852
    UMLS 2011AA Property-2
    C0001418
    NCI Thesaurus Property-3
    C15220
    UMLS 2011AA Property-3
    C0011900
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    T3N0M0, T1-3N1-2M0 disease as determined by pre-neoadjuvant therapy CT scans and pelvic MRI or transrectal ultrasound. Patients with T4 disease are not eligible
    Description

    RectalCarcinomaStageInd-2

    Data type

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    NCI Thesaurus Property
    C16899
    UMLS 2011AA Property
    C1300072
    NCI Thesaurus ObjectClass
    C9382
    UMLS 2011AA ObjectClass
    C0007113
    Start Date of Neoadjuvant therapy
    Description

    NeoadjuvantTreatmentAdministeredBeginDate

    Data type

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ValueDomain-2
    C25431
    UMLS 2011AA ValueDomain-2
    C0439659
    NCI Thesaurus ObjectClass
    C15665
    UMLS 2011AA ObjectClass
    C0600558
    NCI Thesaurus Property
    C25382
    UMLS 2011AA Property
    C1521801
    Date of CT Scan
    Description

    DiagnosticComputedTomographyPerformedDate

    Data type

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ObjectClass
    C17204
    UMLS 2011AA ObjectClass
    C0040405
    NCI Thesaurus Property
    C38000
    UMLS 2011AA Property
    C0884358
    NCI Thesaurus ObjectClass-2
    C25482
    UMLS 2011AA ObjectClass-2
    C0348026
    Date of MRI/TRUS
    Description

    TransrectalUltrasoundProstateAssessmentDate

    Data type

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus Property
    C20989
    UMLS 2011AA Property
    C0031809
    NCI Thesaurus ObjectClass
    C18315
    UMLS 2011AA ObjectClass
    C0373345
    NCI Thesaurus Property-2
    C12410
    UMLS 2011AA Property-2
    C0033572
    End Date of Neoadjuvant therapy
    Description

    NeoadjuvantTreatmentAdministeredEndDate

    Data type

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ObjectClass
    C15665
    UMLS 2011AA ObjectClass
    C0600558
    NCI Thesaurus Property
    C25382
    UMLS 2011AA Property
    C1521801
    Completion of pre-operative 5FU-based chemotherapy and/or radiation therapy. Capecitabine may be substituted for 5FU.
    Description

    PreoperativeTherapeuticProcedureCompleteInd-2

    Data type

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    NCI Thesaurus Property
    C25250
    UMLS 2011AA Property
    C0205197
    NCI Thesaurus ObjectClass
    C54732
    UMLS 2011AA ObjectClass
    C0445204
    NCI Thesaurus ObjectClass-2
    C49236
    UMLS 2011AA ObjectClass-2
    C0087111
    Age >= 18 years
    Description

    PatientAgeInd-2

    Data type

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C25150
    UMLS 2011AA Property
    C0001779
    ECOG (Zubrod) Performance Status <= 2
    Description

    EasternCooperativeOncologyGroupPerformanceStatusAssessmentInd-2

    Data type

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    NCI Thesaurus Property
    C20989
    UMLS 2011AA Property
    C0031809
    NCI Thesaurus ObjectClass
    C25491
    UMLS 2011AA ObjectClass
    C1512162
    NCI Metathesaurus ObjectClass
    CL092952
    ECOG Performance Status (Zubrod)
    Description

    ECOG Performance Status

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25664
    UMLS CUI-1
    C1520224
    NCI Thesaurus Property
    C25367
    NCI Thesaurus ValueDomain-2
    C25491
    NCI Thesaurus ObjectClass
    C20641
    Body Mass Index <= 34 (NOTE: The same value applies to both male and female patients)
    Description

    BodyMassIndexEvaluationInd-2

    Data type

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    NCI Thesaurus Property
    C25214
    UMLS 2011AA Property
    C0220825
    NCI Thesaurus ObjectClass
    C16358
    UMLS 2011AA ObjectClass
    C1305855
    Weight (kg)
    Description

    Patient Weight

    Data type

    float

    Measurement units
    • Kg
    Alias
    NCI Thesaurus ValueDomain
    C25209
    UMLS CUI-1
    C0005910
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25208
    Kg
    Height (cm)
    Description

    Patient Height

    Data type

    float

    Measurement units
    • cm
    Alias
    NCI Thesaurus ValueDomain
    C25209
    UMLS CUI-1
    C0489786
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25347
    cm
    No evidence of conditions that would preclude use of a laparoscopic approach (e.g., multiple previous major laparotomies, severe adhesions).
    Description

    DiseaseorDisorderLaparoscopyPresentInd-2

    Data type

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    NCI Thesaurus Property
    C25626
    UMLS 2011AA Property
    C0150312
    NCI Thesaurus Property-2
    C16969
    UMLS 2011AA Property-2
    C0031150
    NCI Thesaurus ObjectClass
    C2991
    UMLS 2011AA ObjectClass
    C0012634
    No systemic disease (cardiovascular, renal, hepatic, etc.) that would preclude surgery. No other severe incapacitating disease, i.e., ASA IV (a patient with severe systemic disease that is a constant threat to life) or ASA V (a moribund patient who is not expected to survive without the operation)
    Description

    SevereDisabledDiseasesandDisordersPresentInd-2

    Data type

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C63367
    UMLS 2011AA ObjectClass
    C1880351
    NCI Thesaurus ObjectClass-2
    C2991
    UMLS 2011AA ObjectClass-2
    C0012634
    NCI Thesaurus ObjectClass-3
    C70667
    UMLS 2011AA ObjectClass-3
    C0205082
    NCI Thesaurus Property
    C25626
    UMLS 2011AA Property
    C0150312
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    No concurrent or previous invasive pelvic malignancy (cervical, uterine and rectal) within five years prior to registration.
    Description

    PreviousCancerIdentifiedInd-2

    Data type

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    NCI Thesaurus ObjectClass
    C9305
    UMLS 2011AA ObjectClass
    C0006826
    NCI Thesaurus Property
    C25737
    UMLS 2011AA Property
    C0205396
    No history of psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements.
    Description

    PsychiatricDiseaseHistoryInd-2

    Data type

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    NCI Thesaurus ObjectClass
    C25190
    UMLS 2011AA ObjectClass
    C0027361
    NCI Thesaurus Property
    C2893
    UMLS 2011AA Property
    C0004936
    NCI Thesaurus Property-2
    C18772
    UMLS 2011AA Property-2
    C0262926
    Amendment 4 Approval
    Description

    Amendment 4 Approval

    Amendment 4 (dated August 15, 2011) IRB/REB approved
    Description

    ClinicalStudyProtocolInstitutionalReviewBoardApprovalAmendmentInd-2

    Data type

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C25320
    UMLS 2011AA ObjectClass
    C1507394
    NCI Thesaurus Property
    C16741
    UMLS 2011AA Property
    C0086911
    NCI Thesaurus Property-2
    C41200
    UMLS 2011AA Property-2
    C0680532
    NCI Thesaurus Property-3
    C25425
    UMLS 2011AA Property-3
    C0205540
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    Specimen Collection And Banking Consent
    Description

    Specimen Collection And Banking Consent

    Patient has given permission to keep tissue sample(s) for use in future research to learn about, prevent, or treat cancer.
    Description

    PersonSpecimenMalignantNeoplasmFutureClinicalorResearchActivityConsentInd-2

    Data type

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C25190
    UMLS 2011AA ObjectClass
    C0027361
    NCI Thesaurus Property
    C67527
    UMLS 2011AA Property
    C0016884
    NCI Thesaurus Property-2
    C9305
    UMLS 2011AA Property-2
    C0006826
    NCI Thesaurus Property-3
    C19157
    UMLS 2011AA Property-3
    C0370003
    NCI Thesaurus Property-4
    C25460
    UMLS 2011AA Property-4
    C1511481
    NCI Thesaurus Property-5
    C16203
    UMLS 2011AA Property-5
    C1516654
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    Patient has given permission to keep tissue sample(s) for use in research to learn about, prevent or treat other health problems (for example: diabetes, Alzheimer's disease, or heart disease).
    Description

    PersonSpecimenFutureUnrelatedClinicalorResearchActivityConsentInd-2

    Data type

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C25190
    UMLS 2011AA ObjectClass
    C0027361
    NCI Thesaurus Property
    C67527
    UMLS 2011AA Property
    C0016884
    NCI Thesaurus Property-2
    C25328
    UMLS 2011AA Property-2
    C0445356
    NCI Thesaurus Property-3
    C19157
    UMLS 2011AA Property-3
    C0370003
    NCI Thesaurus Property-4
    C25460
    UMLS 2011AA Property-4
    C1511481
    NCI Thesaurus Property-5
    C16203
    UMLS 2011AA Property-5
    C1516654
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    Patient has given permission to keep tissue sample(s) for use in future genetic research.
    Description

    PersonSpecimenMalignantNeoplasmGeneticFutureClinicalorResearchActivityConsentInd-2

    Data type

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C25190
    UMLS 2011AA ObjectClass
    C0027361
    NCI Thesaurus Property
    C67527
    UMLS 2011AA Property
    C0016884
    NCI Thesaurus Property-2
    C9305
    UMLS 2011AA Property-2
    C0006826
    NCI Thesaurus Property-3
    C17938
    UMLS 2011AA Property-3
    C0314603
    NCI Thesaurus Property-4
    C19157
    UMLS 2011AA Property-4
    C0370003
    NCI Thesaurus Property-5
    C25460
    UMLS 2011AA Property-5
    C1511481
    NCI Thesaurus Property-6
    C16203
    UMLS 2011AA Property-6
    C1516654
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    Randomization
    Description

    Randomization

    Randomization
    Description

    AmericanCollegeofSurgeonsOncologyGroupTreatmentArmRandomizationAmericanCollegeofSurgeonsOncologyGroupTreatmentArmRandomizationType

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    NCI Thesaurus Property
    C25196
    UMLS 2011AA Property
    C0034656
    NCI Thesaurus ObjectClass
    C19712
    UMLS 2011AA ObjectClass
    C1515944
    NCI Thesaurus ObjectClass-2
    C15538
    UMLS 2011AA ObjectClass-2
    C1522541

    Similar models

    (Web site address for OPEN portal: http://open.ctsu.org/open/)

    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Header Module
    TreatingInstitutionTextCode
    Item
    Institution CTEP ID
    text
    C25162 (NCI Thesaurus ValueDomain)
    C0805701 (UMLS 2011AA ValueDomain)
    C25705 (NCI Thesaurus ObjectClass)
    C1522326 (UMLS 2011AA ObjectClass)
    C19992 (NCI Thesaurus ObjectClass-2)
    C1516607 (UMLS 2011AA ObjectClass-2)
    CL281747 (NCI Metathesaurus Property)
    Institution Name
    Item
    Institution Name
    text
    C25191 (NCI Thesaurus ValueDomain)
    C1301943 (UMLS CUI-1)
    C21541 (NCI Thesaurus ObjectClass)
    C21541 (NCI Thesaurus ValueDomain-2)
    C25364 (NCI Thesaurus Property)
    Protocol ID ACOSOG
    Item
    Protocol Number
    text
    C25337 (NCI Thesaurus ValueDomain)
    C3274381 (UMLS CUI-1)
    C25320 (NCI Thesaurus ObjectClass)
    C1515944 (UMLS CUI-2)
    C25364 (NCI Thesaurus Property)
    C19712 (NCI Thesaurus Property-2)
    Protocol Title
    Item
    Protocol Title
    text
    C25191 (NCI Thesaurus ValueDomain)
    C2986303 (UMLS CUI-1)
    C25320 (NCI Thesaurus ObjectClass)
    C42774 (NCI Thesaurus Property)
    Registration Number
    Item
    Registration Step
    text
    C25337 (NCI Thesaurus ValueDomain)
    C1514821 (UMLS CUI-1)
    C25646 (NCI Thesaurus ObjectClass)
    C0237753 (UMLS CUI-2)
    C16154 (NCI Thesaurus Property)
    C16154 (NCI Thesaurus ValueDomain-2)
    TreatingPhysicianOrParticipatingInvestigatorName
    Item
    Treating Investigator (Add persons associated with this enrollment)
    text
    C25608 (NCI Thesaurus ObjectClass)
    C0679823 (UMLS 2011AA ObjectClass)
    C37998 (NCI Thesaurus ObjectClass-2)
    C1518602 (UMLS 2011AA ObjectClass-2)
    C51883 (NCI Thesaurus ObjectClass-3)
    C1710470 (UMLS 2011AA ObjectClass-3)
    C25936 (NCI Thesaurus ObjectClass-4)
    C0035173 (UMLS 2011AA ObjectClass-4)
    C25191 (NCI Thesaurus Property)
    C1547383 (UMLS 2011AA Property)
    C25191 (NCI Thesaurus ValueDomain)
    C1547383 (UMLS 2011AA ValueDomain)
    Item Group
    Specify Credits
    ParticipatingGroupIdentifierCode
    Item
    Participating Group Code (Credit Specify Cooperative Group to receive enrollment credit)
    text
    C25162 (NCI Thesaurus ValueDomain)
    C0805701 (UMLS 2011AA ValueDomain)
    C25608 (NCI Thesaurus ObjectClass)
    C0679823 (UMLS 2011AA ObjectClass)
    C17005 (NCI Thesaurus ObjectClass-2)
    C1257890 (UMLS 2011AA ObjectClass-2)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    OtherGroupInvestigatorIdentifierName
    Item
    Other Group Investigator Name (Credit Note: The Credit Investigator must be affiliated with the credited Cooperative Group and will be accountable for the patient and the site's responsibilities during a Cooperative Group Audit)
    text
    C17649 (NCI Thesaurus ObjectClass)
    C0205394 (UMLS 2011AA ObjectClass)
    C25936 (NCI Thesaurus ObjectClass-2)
    C0035173 (UMLS 2011AA ObjectClass-2)
    C43359 (NCI Thesaurus ObjectClass-3)
    C0441833 (UMLS 2011AA ObjectClass-3)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    C25191 (NCI Thesaurus ValueDomain)
    C1547383 (UMLS 2011AA ValueDomain)
    Research Comments
    Item
    Comments (Enter case notes optional)
    text
    C25704 (NCI Thesaurus ValueDomain)
    C0947611 (UMLS CUI-1)
    C15319 (NCI Thesaurus ObjectClass)
    C25393 (NCI Thesaurus Property)
    Item Group
    Patient Information
    PersonBirthDate
    Item
    Date of Birth (month day year)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C25190 (NCI Thesaurus ObjectClass)
    C0027361 (UMLS 2011AA ObjectClass)
    C25155 (NCI Thesaurus Property)
    C0005615 (UMLS 2011AA Property)
    Item
    Gender of a Person
    text
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    C25190 (NCI Thesaurus ObjectClass)
    C0027361 (UMLS 2011AA ObjectClass)
    C17357 (NCI Thesaurus Property)
    C0079399 (UMLS 2011AA Property)
    Code List
    Gender of a Person
    CL Item
    Female Gender (Female Gender)
    C46110 (NCI Thesaurus)
    C0086287 (UMLS 2011AA)
    CL Item
    Male Gender (Male Gender)
    C46109 (NCI Thesaurus)
    C1706180 (UMLS 2011AA)
    CL Item
    Unknown (Unknown)
    C17998 (NCI Thesaurus)
    C0439673 (UMLS 2011AA)
    Item
    Ethnicity
    text
    C25372 (NCI Thesaurus Property)
    C0683312 (UMLS 2011AA Property)
    C25372 (NCI Thesaurus ValueDomain)
    C0683312 (UMLS 2011AA ValueDomain)
    C16564 (NCI Thesaurus ObjectClass)
    C0015031 (UMLS 2011AA ObjectClass)
    Code List
    Ethnicity
    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
    Not Provided Or Available (Not reported)
    C43234 (NCI Thesaurus)
    C1706613 (UMLS 2011AA)
    PersonAddressCountryName
    Item
    Country of Residence
    text
    C25190 (NCI Thesaurus ObjectClass)
    C0027361 (UMLS 2011AA ObjectClass)
    C25464 (NCI Thesaurus ValueDomain)
    C0454664 (UMLS 2011AA ValueDomain)
    C25407 (NCI Thesaurus Property)
    C1442065 (UMLS 2011AA Property)
    C42614 (NCI Thesaurus ValueDomain-2)
    C0027365 (UMLS 2011AA ValueDomain-2)
    PersonAddressPostalCode
    Item
    Zip code
    text
    C25162 (NCI Thesaurus ValueDomain)
    C0805701 (UMLS 2011AA ValueDomain)
    C25190 (NCI Thesaurus ObjectClass)
    C0027361 (UMLS 2011AA ObjectClass)
    C25407 (NCI Thesaurus Property)
    C1442065 (UMLS 2011AA Property)
    Item
    Race
    text
    C25372 (NCI Thesaurus ValueDomain)
    C0034510 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C17049 (NCI Thesaurus Property)
    Code List
    Race
    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
    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)
    CL Item
    Not Provided Or Available (Not Reported)
    C43234 (NCI Thesaurus)
    C1706613 (UMLS 2011AA)
    CL Item
    Could Not Be Determined Or Unsure (Unknown)
    C17998 (NCI Thesaurus)
    C0439673 (UMLS 2011AA)
    Item
    Method of Payment
    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
    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 Or Veterans Sponsored Nos (Military or Veterans Sponsored, Not Otherwise Specified (NOS))
    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
    Veterans Sponsored (Veterans Sponsored)
    CL Item
    Unknown (Unknown)
    C17998 (NCI Thesaurus)
    C0439673 (UMLS 2011AA)
    Item Group
    General Information
    PatientIdentifier
    Item
    Pt ID# (Local Patient Identifier)
    text
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    C25364 (NCI Thesaurus ValueDomain)
    C0600091 (UMLS 2011AA ValueDomain)
    Patient Initials Last
    Item
    Last (initial)
    text
    C25191 (NCI Thesaurus ValueDomain)
    C2986440 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C1517741 (UMLS CUI-2)
    C25536 (NCI Thesaurus Property)
    C25551 (NCI Thesaurus Property-2)
    Patient Initials First
    Item
    First (initial)
    text
    C25191 (NCI Thesaurus ValueDomain)
    C2986440 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C0205435 (UMLS CUI-2)
    C25536 (NCI Thesaurus Property)
    C25509 (NCI Thesaurus Property-2)
    PatientMiddleInitialsName
    Item
    Middle (initial optional)
    text
    C25191 (NCI Thesaurus ValueDomain)
    C1547383 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25536 (NCI Thesaurus Property)
    C1555582 (UMLS 2011AA Property)
    C25569 (NCI Thesaurus Property-2)
    C0444598 (UMLS 2011AA Property-2)
    ResponsiblePersonE-mailAddressText
    Item
    E-mail (for Registration Confirmation)
    text
    C25704 (NCI Thesaurus ValueDomain)
    C1527021 (UMLS 2011AA ValueDomain)
    C25657 (NCI Thesaurus ObjectClass)
    C1273518 (UMLS 2011AA ObjectClass)
    C42775 (NCI Thesaurus Property)
    C1705961 (UMLS 2011AA Property)
    InformedConsentFormSignedDate
    Item
    Date Informed Consent Signed (month day year)
    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)
    HealthInsurancePortabilityandAccountabilityActAuthorizationIndicator
    Item
    Was HIPAA Authorization included in Study Informed Consent (mark one)
    boolean
    C25180 (NCI Thesaurus ValueDomain)
    C1522602 (UMLS 2011AA ValueDomain)
    C62504 (NCI Thesaurus ObjectClass)
    C0600593 (UMLS 2011AA ObjectClass)
    C41192 (NCI Thesaurus Property)
    C1524004 (UMLS 2011AA Property)
    HealthInsurancePortabilityandAccountabilityActTissueDonorAuthorizationDate
    Item
    HIPAA authorization date (If no, month day year)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C25168 (NCI Thesaurus Property)
    C0040288 (UMLS 2011AA Property)
    C62504 (NCI Thesaurus ObjectClass)
    C0600593 (UMLS 2011AA ObjectClass)
    C41192 (NCI Thesaurus Property-2)
    C1524004 (UMLS 2011AA Property-2)
    Item Group
    Stratification Factors
    Item
    Site of primary tumor
    text
    C13717 (NCI Thesaurus ValueDomain)
    C1515974 (UMLS 2011AA ValueDomain)
    C25341 (NCI Thesaurus Property)
    C0450429 (UMLS 2011AA Property)
    C9382 (NCI Thesaurus ObjectClass)
    C0007113 (UMLS 2011AA ObjectClass)
    Code List
    Site of primary tumor
    CL Item
    Z6051-f1-l1 (High rectum)
    CL Item
    Z6051-f1-l2 (Middle rectum)
    CL Item
    Z6051-f1-l3 (Low rectum)
    Item
    Planned operative procedure
    text
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    C13363 (NCI Thesaurus ObjectClass)
    C0555952 (UMLS 2011AA ObjectClass)
    C15329 (NCI Thesaurus ObjectClass-2)
    C0543467 (UMLS 2011AA ObjectClass-2)
    C25619 (NCI Thesaurus Property)
    C1301732 (UMLS 2011AA Property)
    Code List
    Planned operative procedure
    CL Item
    Z6051-f2-l1 (Low anterior resection)
    CL Item
    Z6051-f2-l2 (Abdominal perineal resection)
    Item Group
    Eligibility Criteria
    RectalCarcinomaAdenocarcinomaHistologyDiagnosisInd-2
    Item
    Histologic diagnosis of adenocarcinoma of the rectum (<= 12cm from the anal verge)
    boolean
    C9382 (NCI Thesaurus ObjectClass)
    C0007113 (UMLS 2011AA ObjectClass)
    C16681 (NCI Thesaurus Property)
    C0019638 (UMLS 2011AA Property)
    C2852 (NCI Thesaurus Property-2)
    C0001418 (UMLS 2011AA Property-2)
    C15220 (NCI Thesaurus Property-3)
    C0011900 (UMLS 2011AA Property-3)
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    RectalCarcinomaStageInd-2
    Item
    T3N0M0, T1-3N1-2M0 disease as determined by pre-neoadjuvant therapy CT scans and pelvic MRI or transrectal ultrasound. Patients with T4 disease are not eligible
    boolean
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    C16899 (NCI Thesaurus Property)
    C1300072 (UMLS 2011AA Property)
    C9382 (NCI Thesaurus ObjectClass)
    C0007113 (UMLS 2011AA ObjectClass)
    NeoadjuvantTreatmentAdministeredBeginDate
    Item
    Start Date of Neoadjuvant therapy
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C25431 (NCI Thesaurus ValueDomain-2)
    C0439659 (UMLS 2011AA ValueDomain-2)
    C15665 (NCI Thesaurus ObjectClass)
    C0600558 (UMLS 2011AA ObjectClass)
    C25382 (NCI Thesaurus Property)
    C1521801 (UMLS 2011AA Property)
    DiagnosticComputedTomographyPerformedDate
    Item
    Date of CT Scan
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C17204 (NCI Thesaurus ObjectClass)
    C0040405 (UMLS 2011AA ObjectClass)
    C38000 (NCI Thesaurus Property)
    C0884358 (UMLS 2011AA Property)
    C25482 (NCI Thesaurus ObjectClass-2)
    C0348026 (UMLS 2011AA ObjectClass-2)
    TransrectalUltrasoundProstateAssessmentDate
    Item
    Date of MRI/TRUS
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C20989 (NCI Thesaurus Property)
    C0031809 (UMLS 2011AA Property)
    C18315 (NCI Thesaurus ObjectClass)
    C0373345 (UMLS 2011AA ObjectClass)
    C12410 (NCI Thesaurus Property-2)
    C0033572 (UMLS 2011AA Property-2)
    NeoadjuvantTreatmentAdministeredEndDate
    Item
    End Date of Neoadjuvant therapy
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C15665 (NCI Thesaurus ObjectClass)
    C0600558 (UMLS 2011AA ObjectClass)
    C25382 (NCI Thesaurus Property)
    C1521801 (UMLS 2011AA Property)
    PreoperativeTherapeuticProcedureCompleteInd-2
    Item
    Completion of pre-operative 5FU-based chemotherapy and/or radiation therapy. Capecitabine may be substituted for 5FU.
    boolean
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    C25250 (NCI Thesaurus Property)
    C0205197 (UMLS 2011AA Property)
    C54732 (NCI Thesaurus ObjectClass)
    C0445204 (UMLS 2011AA ObjectClass)
    C49236 (NCI Thesaurus ObjectClass-2)
    C0087111 (UMLS 2011AA ObjectClass-2)
    PatientAgeInd-2
    Item
    Age >= 18 years
    boolean
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25150 (NCI Thesaurus Property)
    C0001779 (UMLS 2011AA Property)
    EasternCooperativeOncologyGroupPerformanceStatusAssessmentInd-2
    Item
    ECOG (Zubrod) Performance Status <= 2
    boolean
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    C20989 (NCI Thesaurus Property)
    C0031809 (UMLS 2011AA Property)
    C25491 (NCI Thesaurus ObjectClass)
    C1512162 (UMLS 2011AA ObjectClass)
    CL092952 (NCI Metathesaurus ObjectClass)
    Item
    ECOG Performance Status (Zubrod)
    text
    C25664 (NCI Thesaurus ValueDomain)
    C1520224 (UMLS CUI-1)
    C25367 (NCI Thesaurus Property)
    C25491 (NCI Thesaurus ValueDomain-2)
    C20641 (NCI Thesaurus ObjectClass)
    Code List
    ECOG Performance Status (Zubrod)
    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)
    BodyMassIndexEvaluationInd-2
    Item
    Body Mass Index <= 34 (NOTE: The same value applies to both male and female patients)
    boolean
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    C25214 (NCI Thesaurus Property)
    C0220825 (UMLS 2011AA Property)
    C16358 (NCI Thesaurus ObjectClass)
    C1305855 (UMLS 2011AA ObjectClass)
    Patient Weight
    Item
    Weight (kg)
    float
    C25209 (NCI Thesaurus ValueDomain)
    C0005910 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C25208 (NCI Thesaurus Property)
    Patient Height
    Item
    Height (cm)
    float
    C25209 (NCI Thesaurus ValueDomain)
    C0489786 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C25347 (NCI Thesaurus Property)
    DiseaseorDisorderLaparoscopyPresentInd-2
    Item
    No evidence of conditions that would preclude use of a laparoscopic approach (e.g., multiple previous major laparotomies, severe adhesions).
    boolean
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    C25626 (NCI Thesaurus Property)
    C0150312 (UMLS 2011AA Property)
    C16969 (NCI Thesaurus Property-2)
    C0031150 (UMLS 2011AA Property-2)
    C2991 (NCI Thesaurus ObjectClass)
    C0012634 (UMLS 2011AA ObjectClass)
    SevereDisabledDiseasesandDisordersPresentInd-2
    Item
    No systemic disease (cardiovascular, renal, hepatic, etc.) that would preclude surgery. No other severe incapacitating disease, i.e., ASA IV (a patient with severe systemic disease that is a constant threat to life) or ASA V (a moribund patient who is not expected to survive without the operation)
    boolean
    C63367 (NCI Thesaurus ObjectClass)
    C1880351 (UMLS 2011AA ObjectClass)
    C2991 (NCI Thesaurus ObjectClass-2)
    C0012634 (UMLS 2011AA ObjectClass-2)
    C70667 (NCI Thesaurus ObjectClass-3)
    C0205082 (UMLS 2011AA ObjectClass-3)
    C25626 (NCI Thesaurus Property)
    C0150312 (UMLS 2011AA Property)
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    PreviousCancerIdentifiedInd-2
    Item
    No concurrent or previous invasive pelvic malignancy (cervical, uterine and rectal) within five years prior to registration.
    boolean
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    C9305 (NCI Thesaurus ObjectClass)
    C0006826 (UMLS 2011AA ObjectClass)
    C25737 (NCI Thesaurus Property)
    C0205396 (UMLS 2011AA Property)
    PsychiatricDiseaseHistoryInd-2
    Item
    No history of psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements.
    boolean
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    C25190 (NCI Thesaurus ObjectClass)
    C0027361 (UMLS 2011AA ObjectClass)
    C2893 (NCI Thesaurus Property)
    C0004936 (UMLS 2011AA Property)
    C18772 (NCI Thesaurus Property-2)
    C0262926 (UMLS 2011AA Property-2)
    Item Group
    Amendment 4 Approval
    ClinicalStudyProtocolInstitutionalReviewBoardApprovalAmendmentInd-2
    Item
    Amendment 4 (dated August 15, 2011) IRB/REB approved
    boolean
    C25320 (NCI Thesaurus ObjectClass)
    C1507394 (UMLS 2011AA ObjectClass)
    C16741 (NCI Thesaurus Property)
    C0086911 (UMLS 2011AA Property)
    C41200 (NCI Thesaurus Property-2)
    C0680532 (UMLS 2011AA Property-2)
    C25425 (NCI Thesaurus Property-3)
    C0205540 (UMLS 2011AA Property-3)
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    Item Group
    Specimen Collection And Banking Consent
    PersonSpecimenMalignantNeoplasmFutureClinicalorResearchActivityConsentInd-2
    Item
    Patient has given permission to keep tissue sample(s) for use in future research to learn about, prevent, or treat cancer.
    boolean
    C25190 (NCI Thesaurus ObjectClass)
    C0027361 (UMLS 2011AA ObjectClass)
    C67527 (NCI Thesaurus Property)
    C0016884 (UMLS 2011AA Property)
    C9305 (NCI Thesaurus Property-2)
    C0006826 (UMLS 2011AA Property-2)
    C19157 (NCI Thesaurus Property-3)
    C0370003 (UMLS 2011AA Property-3)
    C25460 (NCI Thesaurus Property-4)
    C1511481 (UMLS 2011AA Property-4)
    C16203 (NCI Thesaurus Property-5)
    C1516654 (UMLS 2011AA Property-5)
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    PersonSpecimenFutureUnrelatedClinicalorResearchActivityConsentInd-2
    Item
    Patient has given permission to keep tissue sample(s) for use in research to learn about, prevent or treat other health problems (for example: diabetes, Alzheimer's disease, or heart disease).
    boolean
    C25190 (NCI Thesaurus ObjectClass)
    C0027361 (UMLS 2011AA ObjectClass)
    C67527 (NCI Thesaurus Property)
    C0016884 (UMLS 2011AA Property)
    C25328 (NCI Thesaurus Property-2)
    C0445356 (UMLS 2011AA Property-2)
    C19157 (NCI Thesaurus Property-3)
    C0370003 (UMLS 2011AA Property-3)
    C25460 (NCI Thesaurus Property-4)
    C1511481 (UMLS 2011AA Property-4)
    C16203 (NCI Thesaurus Property-5)
    C1516654 (UMLS 2011AA Property-5)
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    PersonSpecimenMalignantNeoplasmGeneticFutureClinicalorResearchActivityConsentInd-2
    Item
    Patient has given permission to keep tissue sample(s) for use in future genetic research.
    boolean
    C25190 (NCI Thesaurus ObjectClass)
    C0027361 (UMLS 2011AA ObjectClass)
    C67527 (NCI Thesaurus Property)
    C0016884 (UMLS 2011AA Property)
    C9305 (NCI Thesaurus Property-2)
    C0006826 (UMLS 2011AA Property-2)
    C17938 (NCI Thesaurus Property-3)
    C0314603 (UMLS 2011AA Property-3)
    C19157 (NCI Thesaurus Property-4)
    C0370003 (UMLS 2011AA Property-4)
    C25460 (NCI Thesaurus Property-5)
    C1511481 (UMLS 2011AA Property-5)
    C16203 (NCI Thesaurus Property-6)
    C1516654 (UMLS 2011AA Property-6)
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    Item Group
    Randomization
    Item
    Randomization
    text
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    C25196 (NCI Thesaurus Property)
    C0034656 (UMLS 2011AA Property)
    C19712 (NCI Thesaurus ObjectClass)
    C1515944 (UMLS 2011AA ObjectClass)
    C15538 (NCI Thesaurus ObjectClass-2)
    C1522541 (UMLS 2011AA ObjectClass-2)
    Code List
    Randomization
    CL Item
    Open Laparotomy And Rectal Resection (Open laparotomy and rectal resection)
    CL Item
    Laparoscopic-assisted Rectal Resection (Laparoscopic-assisted rectal resection)

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