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ID

11694

Beskrivning

N0874 Pre-Registration (Step 1) Eligibility Checklist Vorinostat, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=7F194A19-97CE-83E0-E040-BB89AD431393

Länk

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=7F194A19-97CE-83E0-E040-BB89AD431393

Nyckelord

Versioner (4)
  1. 2015-07-28 2015-07-28 - Julian Varghese
  2. 2015-07-28 2015-07-28 - Julian Varghese
  3. 2015-12-04 2015-12-04 - Julian Varghese
  4. 2021-09-17 2021-09-17 -
Uppladdad den

28 juli 2015

DOI

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Licens

Creative Commons BY-NC 3.0 Legacy
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    Glioblastoma multiforme N0874

    Engelsk

    Phase I NCCTG Only (Limited to Mayo Rochester, Florida, and Arizona): Prior to discussing protocol entry with the patient, call the NCCTG Registration Office (507/284-4130) for dose level and to insure that a place on the protocol is open to the patient. To register a patient fax (507/284-0885) a completed eligibility checklist to the Registration Office between 8 a.m. and 4:30 p.m. Central time Monday through Friday. Phase II: All site staff (NCCTG and ABTC sites) will use the Oncology Patient Enrollment Network (OPEN) to enroll patients to each step of this study. OPEN can be accessed at https://open.ctsu.org or from the OPEN tab on the CTSU members' side of the website at https://www.ctsu.org

    1 Formulär  
    Header
    Beskrivning

    Header

    Pre-Registration date
    Beskrivning

    PatientPriorRegistrationDate

    Datatyp

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164 (undefined)
    UMLS 2011AA ValueDomain
    C0011008 (Date in time)
    SNOMED
    410671006
    NCI Thesaurus ObjectClass
    C16960 (undefined)
    UMLS 2011AA ObjectClass
    C0030705 (Patients)
    SNOMED
    116154003
    NCI Thesaurus Property
    C25646 (undefined)
    UMLS 2011AA Property
    C1514821 (Registration)
    NCI Thesaurus Property-2
    C25629 (undefined)
    UMLS 2011AA Property-2
    C0332152 (Before)
    SNOMED
    236874000
    NCCTG Patient ID
    Beskrivning

    PatientNorthCentralCancerTreatmentGroupIdentifierNumber

    Datatyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337 (undefined)
    UMLS 2011AA ValueDomain
    C0237753 (Numbers)
    SNOMED
    260299005
    LOINC
    LP6841-3
    NCI Thesaurus ObjectClass
    C16960 (undefined)
    UMLS 2011AA ObjectClass
    C0030705 (Patients)
    SNOMED
    116154003
    NCI Thesaurus Property
    C25364 (undefined)
    UMLS 2011AA Property
    C0600091 (Identifier)
    SNOMED
    118522005
    LOINC
    LP31795-5
    NCI Thesaurus Property-2
    C25581 (undefined)
    UMLS 2011AA Property-2
    C1518419 (North Central Cancer Treatment Group)
    Participating Group Code (participant sponsor)
    Beskrivning

    ParticipatingGroupIdentifierCode

    Datatyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25162 (undefined)
    UMLS 2011AA ValueDomain
    C0805701 (Code)
    NCI Thesaurus ObjectClass
    C25608 (undefined)
    UMLS 2011AA ObjectClass
    C0679823 (Participation)
    NCI Thesaurus ObjectClass-2
    C17005 (undefined)
    UMLS 2011AA ObjectClass-2
    C1257890 (Population Group)
    SNOMED
    389109008
    LOINC
    LA12078-4
    NCI Thesaurus Property
    C25364 (undefined)
    UMLS 2011AA Property
    C0600091 (Identifier)
    SNOMED
    118522005
    LOINC
    LP31795-5
    Institution (treating location)
    Beskrivning

    Institution Name

    Datatyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191 (undefined)
    UMLS CUI-1
    C1301943 (Institution name)
    SNOMED
    398321007
    NCI Thesaurus ObjectClass
    C21541 (undefined)
    NCI Thesaurus ValueDomain-2
    C21541 (undefined)
    NCI Thesaurus Property
    C25364 (undefined)
    Physician of Record
    Beskrivning

    Investigator Name

    Datatyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191 (undefined)
    UMLS CUI-1
    C2826892 (Investigator Name)
    NCI Thesaurus Property
    C25364 (undefined)
    NCI Thesaurus ObjectClass
    C17089 (undefined)
    NCI Thesaurus ObjectClass-2
    C25644 (undefined)
    Patient Medical Record Number
    Beskrivning

    Medical Record Number

    Datatyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337 (undefined)
    UMLS CUI-1
    C1301894 (Medical record number)
    SNOMED
    398225001
    LOINC
    MTHU047637
    NCI Thesaurus ObjectClass
    C16960 (undefined)
    NCI Thesaurus Property
    C25261 (undefined)
    NCI Thesaurus Property-2
    C25198 (undefined)
    Last name
    Beskrivning

    Person Completing Form Last Name

    Datatyp

    text

    Alias
    NCI Thesaurus ObjectClass
    C25190 (undefined)
    UMLS CUI-1
    C1550483 (data entry person)
    NCI Thesaurus ObjectClass-2
    C25657 (undefined)
    UMLS CUI-2
    C1301584 (Last Name)
    SNOMED
    397678008
    NCI Thesaurus Property
    C25364 (undefined)
    NCI Thesaurus Property-2
    C25551 (undefined)
    NCI Thesaurus ValueDomain
    C25191 (undefined)
    First Name
    Beskrivning

    Person Completing Form First Name

    Datatyp

    text

    Alias
    NCI Thesaurus ObjectClass
    C25190 (undefined)
    UMLS CUI-1
    C1550483 (data entry person)
    NCI Thesaurus ObjectClass-2
    C25657 (undefined)
    UMLS CUI-2
    C1443235 (First Name)
    SNOMED
    408677003
    LOINC
    MTHU048693
    NCI Thesaurus Property
    C25364 (undefined)
    NCI Thesaurus Property-2
    C25509 (undefined)
    NCI Thesaurus ValueDomain
    C25191 (undefined)
    Phone
    Beskrivning

    Person Completing Form Phone

    Datatyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337 (undefined)
    UMLS CUI-1
    C1550483 (data entry person)
    NCI Thesaurus ObjectClass
    C25190 (undefined)
    UMLS CUI-2
    C1515258 (Telephone Number)
    SNOMED
    734005006
    LOINC
    LP6871-0
    NCI Thesaurus ObjectClass-2
    C25657 (undefined)
    NCI Thesaurus Property
    C25395 (undefined)
    Fax
    Beskrivning

    ResponsiblePersonFaxNumber

    Datatyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337 (undefined)
    UMLS 2011AA ValueDomain
    C0237753 (Numbers)
    SNOMED
    260299005
    LOINC
    LP6841-3
    NCI Thesaurus ObjectClass
    C25190 (undefined)
    UMLS 2011AA ObjectClass
    C0027361 (Persons)
    SNOMED
    125676002
    NCI Thesaurus ObjectClass-2
    C25657 (undefined)
    UMLS 2011AA ObjectClass-2
    C1273518 (Responsible to (attribute))
    SNOMED
    394851003
    NCI Thesaurus Property
    C25210 (undefined)
    UMLS 2011AA Property
    C0085205 (Telefacsimile)
    E-mail
    Beskrivning

    ResponsiblePersonE-mailAddressText

    Datatyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25704 (undefined)
    UMLS 2011AA ValueDomain
    C1527021 (Text)
    LOINC
    LP6885-0
    NCI Thesaurus ObjectClass
    C25657 (undefined)
    UMLS 2011AA ObjectClass
    C1273518 (Responsible to (attribute))
    SNOMED
    394851003
    NCI Thesaurus Property
    C42775 (undefined)
    UMLS 2011AA Property
    C1705961 (E-mail Address)
    LOINC
    LP91370-4
    Patient Demographics / Pre-treatment Characteristics
    Beskrivning

    Patient Demographics / Pre-treatment Characteristics

    Alias
    UMLS CUI-1
    C1704791 (Demographics Domain)
    Patient Initials
    Beskrivning

    Patient Initials

    Datatyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191 (undefined)
    UMLS CUI-1
    C2986440 (Person Initials)
    NCI Thesaurus ObjectClass
    C16960 (undefined)
    NCI Thesaurus Property
    C25536 (undefined)
    Gender
    Beskrivning

    Gender

    Datatyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25372 (undefined)
    UMLS CUI-1
    C0079399 (Gender)
    SNOMED
    263495000
    LOINC
    LP61312-2
    NCI Thesaurus ObjectClass
    C16960 (undefined)
    NCI Thesaurus Property
    C17357 (undefined)
    Date of Birth
    Beskrivning

    PersonBirthDate

    Datatyp

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164 (undefined)
    UMLS 2011AA ValueDomain
    C0011008 (Date in time)
    SNOMED
    410671006
    NCI Thesaurus ObjectClass
    C25190 (undefined)
    UMLS 2011AA ObjectClass
    C0027361 (Persons)
    SNOMED
    125676002
    NCI Thesaurus Property
    C25155 (undefined)
    UMLS 2011AA Property
    C0005615 (Birth)
    SNOMED
    3950001
    Zip code
    Beskrivning

    PersonAddressPostalCode

    Datatyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25162 (undefined)
    UMLS 2011AA ValueDomain
    C0805701 (Code)
    NCI Thesaurus ObjectClass
    C25190 (undefined)
    UMLS 2011AA ObjectClass
    C0027361 (Persons)
    SNOMED
    125676002
    NCI Thesaurus Property
    C25407 (undefined)
    UMLS 2011AA Property
    C1442065 (Address)
    SNOMED
    397635003
    LOINC
    LP96251-1
    Country of Residence
    Beskrivning

    PersonAddressCountryName

    Datatyp

    text

    Alias
    NCI Thesaurus ObjectClass
    C25190 (undefined)
    UMLS 2011AA ObjectClass
    C0027361 (Persons)
    SNOMED
    125676002
    NCI Thesaurus ValueDomain
    C25464 (undefined)
    UMLS 2011AA ValueDomain
    C0454664 (Country)
    SNOMED
    223369002
    LOINC
    LP120625-1
    NCI Thesaurus Property
    C25407 (undefined)
    UMLS 2011AA Property
    C1442065 (Address)
    SNOMED
    397635003
    LOINC
    LP96251-1
    NCI Thesaurus ValueDomain-2
    C42614 (undefined)
    UMLS 2011AA ValueDomain-2
    C0027365 (Name)
    SNOMED
    703503000
    LOINC
    LP72974-6
    Method of Payment (check oneUSA only)
    Beskrivning

    PatientPaymentType

    Datatyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284 (undefined)
    UMLS 2011AA ValueDomain
    C0332307 (Type - attribute)
    SNOMED
    261664005
    NCI Thesaurus ObjectClass
    C16960 (undefined)
    UMLS 2011AA ObjectClass
    C0030705 (Patients)
    SNOMED
    116154003
    NCI Thesaurus Property
    C25371 (undefined)
    UMLS 2011AA Property
    C0680264 (payment)
    Race
    Beskrivning

    Racial Group

    Datatyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25372 (undefined)
    UMLS CUI-1
    C0034510 (Racial group)
    SNOMED
    415229000
    LOINC
    LP7528-5
    NCI Thesaurus ObjectClass
    C16960 (undefined)
    NCI Thesaurus Property
    C17049 (undefined)
    Ethnicity
    Beskrivning

    Ethnic Group

    Datatyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25372 (undefined)
    UMLS CUI-1
    C0015031 (Ethnic group)
    SNOMED
    398089004
    LOINC
    LP36231-6
    NCI Thesaurus ObjectClass
    C16960 (undefined)
    NCI Thesaurus Property
    C16564 (undefined)
    Unnamed 1
    Beskrivning

    Unnamed 1

    NCCTG Patient ID
    Beskrivning

    PatientNorthCentralCancerTreatmentGroupIdentifierNumber

    Datatyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337 (undefined)
    UMLS 2011AA ValueDomain
    C0237753 (Numbers)
    SNOMED
    260299005
    LOINC
    LP6841-3
    NCI Thesaurus ObjectClass
    C16960 (undefined)
    UMLS 2011AA ObjectClass
    C0030705 (Patients)
    SNOMED
    116154003
    NCI Thesaurus Property
    C25364 (undefined)
    UMLS 2011AA Property
    C0600091 (Identifier)
    SNOMED
    118522005
    LOINC
    LP31795-5
    NCI Thesaurus Property-2
    C25581 (undefined)
    UMLS 2011AA Property-2
    C1518419 (North Central Cancer Treatment Group)
    Intensity modulated radiation therapy
    Beskrivning

    Intensity modulated radiation therapy

    Alias
    UMLS CUI-1
    C1512814 (Radiotherapy, Intensity-Modulated)
    SNOMED
    441799006
    Is your site using IMRT for this study?
    Beskrivning

    IMRT usage

    Datatyp

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38148 (undefined)
    NCI Thesaurus Property
    C16135 (undefined)
    NCI Thesaurus ObjectClass
    C41206 (undefined)
    NCI Thesaurus Property-2
    C25409 (undefined)
    UMLS CUI-1
    C1512814 (Radiotherapy, Intensity-Modulated)
    SNOMED
    441799006
    If yes, is your site certified?
    Beskrivning

    IMRT Certification

    Datatyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C38148 (undefined)
    NCI Thesaurus Property
    C16135 (undefined)
    NCI Thesaurus ObjectClass
    C41206 (undefined)
    NCI Thesaurus Property-2
    C43610 (undefined)
    UMLS CUI-1
    C1512814 (Radiotherapy, Intensity-Modulated)
    SNOMED
    441799006
    UMLS CUI-2
    C0007836 (Certification)
    LOINC
    MTHU051518
    Neurocognitive Testing Certification
    Beskrivning

    Neurocognitive Testing Certification

    Is at least one individual at your site certified for Neurocognitive testing
    Beskrivning

    Person certified for neurocognitive testing

    Datatyp

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C25190 (undefined)
    NCI Thesaurus Property
    C81313 (undefined)
    NCI Thesaurus Property-2
    C41206 (undefined)
    NCI Thesaurus Property-3
    C73925 (undefined)
    NCI Thesaurus ValueDomain
    C38148 (undefined)
    UMLS CUI-1
    C0027361 (Persons)
    SNOMED
    125676002
    UMLS CUI-2
    C0027853 (Neurologic Examination)
    SNOMED
    225398001
    LOINC
    LP133273-5
    UMLS CUI-3
    C1272753 (Institution (social concept))
    SNOMED
    385437003
    UMLS CUI-4
    C2362313 (Credential letter)
    Eligibility Check
    Beskrivning

    Eligibility Check

    Central pathology review submission. This review is mandatory prior to registration to confirm eligibility. It should be initiated as soon after surgery as possible.
    Beskrivning

    PathologySpecimenCentralReviewerSubmissionInd-2

    Datatyp

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C19157 (undefined)
    UMLS 2011AA ObjectClass
    C0370003 (Specimen)
    SNOMED
    123038009
    LOINC
    LP7593-9
    NCI Thesaurus ObjectClass-2
    C18189 (undefined)
    UMLS 2011AA ObjectClass-2
    C0030664 (Pathology)
    SNOMED
    394595002
    NCI Thesaurus Property
    C25694 (undefined)
    UMLS 2011AA Property
    C1515022 (Submission)
    LOINC
    LP91032-0
    NCI Thesaurus Property-2
    C51807 (undefined)
    UMLS 2011AA Property-2
    C1707338 (Central Reviewer)
    NCI Thesaurus ValueDomain
    C38147 (undefined)
    UMLS 2011AA ValueDomain
    C1512698 (Yes or No Response)
    Treatment should begin >=2 weeks and <=5 weeks following surgery
    Beskrivning

    TherapyBeginRequirementInd-2

    Datatyp

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38147 (undefined)
    UMLS 2011AA ValueDomain
    C1512698 (Yes or No Response)
    NCI Thesaurus ObjectClass
    C15368 (undefined)
    NCI Thesaurus Property
    C25431 (undefined)
    UMLS 2011AA Property
    C0439659 (Beginning)
    SNOMED
    255395001
    LOINC
    LP21371-7
    NCI Thesaurus Property-2
    C38015 (undefined)
    Pre-registration Check
    Beskrivning

    Pre-registration Check

    Consent form signed and dated
    Beskrivning

    InformedConsentFormSignedInd-2

    Datatyp

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38147 (undefined)
    UMLS 2011AA ValueDomain
    C1512698 (Yes or No Response)
    NCI Thesaurus ObjectClass
    C16468 (undefined)
    UMLS 2011AA ObjectClass
    C0009797 (Consent Forms)
    NCI Thesaurus Property
    C25679 (undefined)
    Date Informed Consent Signed
    Beskrivning

    InformedConsentFormSignedDate

    Datatyp

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164 (undefined)
    UMLS 2011AA ValueDomain
    C0011008 (Date in time)
    SNOMED
    410671006
    NCI Thesaurus ValueDomain-2
    C25367 (undefined)
    NCI Thesaurus ObjectClass
    C16468 (undefined)
    UMLS 2011AA ObjectClass
    C0009797 (Consent Forms)
    NCI Thesaurus Property
    C25679 (undefined)
    Authorization for use and disclosure of protected health information signed and dated (If not a USA institution check NA)
    Beskrivning

    PatientHealthRecordIndicator

    Datatyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25180 (undefined)
    UMLS 2011AA ValueDomain
    C1522602 (Indicator)
    NCI Thesaurus ObjectClass
    C16960 (undefined)
    UMLS 2011AA ObjectClass
    C0030705 (Patients)
    SNOMED
    116154003
    NCI Thesaurus Property
    C25178 (undefined)
    UMLS 2011AA Property
    C0018684 (Health)
    SNOMED
    263775005
    LOINC
    LA17983-0
    Date of authorization (If a USA institution)
    Beskrivning

    HealthInsurancePortabilityandAccountabilityActTissueDonorAuthorizationDate

    Datatyp

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164 (undefined)
    UMLS 2011AA ValueDomain
    C0011008 (Date in time)
    SNOMED
    410671006
    NCI Thesaurus Property
    C25168 (undefined)
    UMLS 2011AA Property
    C0040288 (Tissue Donors)
    SNOMED
    105468003
    LOINC
    LA27572-9
    NCI Thesaurus ObjectClass
    C62504 (undefined)
    UMLS 2011AA ObjectClass
    C0600593 (Health Insurance Portability and Accountability Act)
    NCI Thesaurus Property-2
    C41192 (undefined)
    UMLS 2011AA Property-2
    C1524004 (Authorization documentation)
    The site has reviewed and understands the process listed in Section 17.0 and must account for sufficient time to complete pre-registration and registration steps
    Beskrivning

    CentralPathologyReviewPriorRandomizationRequirementInd-2

    Datatyp

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C71684 (undefined)
    UMLS 2011AA ObjectClass
    C2347585 (Central Pathology Review)
    NCI Thesaurus Property
    C25196 (undefined)
    UMLS 2011AA Property
    C0034656 (Randomization)
    NCI Thesaurus Property-2
    C25629 (undefined)
    UMLS 2011AA Property-2
    C0332152 (Before)
    SNOMED
    236874000
    NCI Thesaurus Property-3
    C25652 (undefined)
    UMLS 2011AA Property-3
    C1514873 (Requirement)
    NCI Thesaurus ValueDomain
    C38147 (undefined)
    UMLS 2011AA ValueDomain
    C1512698 (Yes or No Response)
    An NCCTG or ABTC approved radiation oncologist has seen the patient and confirms the patient is a suitable candidate for this study
    Beskrivning

    Radiation oncologist confirmed patient eligibility

    Datatyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C38148 (undefined)
    NCI Thesaurus ObjectClass
    C16960 (undefined)
    NCI Thesaurus Property
    C25171 (undefined)
    UMLS CUI-1
    C0030705 (Patients)
    SNOMED
    116154003
    UMLS CUI-2
    C0013893 (Eligibility Determination)
    Tillbaka till toppen

    Similar models

    Phase I NCCTG Only (Limited to Mayo Rochester, Florida, and Arizona): Prior to discussing protocol entry with the patient, call the NCCTG Registration Office (507/284-4130) for dose level and to insure that a place on the protocol is open to the patient. To register a patient fax (507/284-0885) a completed eligibility checklist to the Registration Office between 8 a.m. and 4:30 p.m. Central time Monday through Friday. Phase II: All site staff (NCCTG and ABTC sites) will use the Oncology Patient Enrollment Network (OPEN) to enroll patients to each step of this study. OPEN can be accessed at https://open.ctsu.org or from the OPEN tab on the CTSU members' side of the website at https://www.ctsu.org

    1 Formulär
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    Header
    PatientPriorRegistrationDate
    Item
    Pre-Registration date
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25646 (NCI Thesaurus Property)
    C1514821 (UMLS 2011AA Property)
    C25629 (NCI Thesaurus Property-2)
    C0332152 (UMLS 2011AA Property-2)
    PatientNorthCentralCancerTreatmentGroupIdentifierNumber
    Item
    NCCTG Patient ID
    text
    C25337 (NCI Thesaurus ValueDomain)
    C0237753 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    C25581 (NCI Thesaurus Property-2)
    C1518419 (UMLS 2011AA Property-2)
    ParticipatingGroupIdentifierCode
    Item
    Participating Group Code (participant sponsor)
    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)
    Institution Name
    Item
    Institution (treating location)
    text
    C25191 (NCI Thesaurus ValueDomain)
    C1301943 (UMLS CUI-1)
    C21541 (NCI Thesaurus ObjectClass)
    C21541 (NCI Thesaurus ValueDomain-2)
    C25364 (NCI Thesaurus Property)
    Investigator Name
    Item
    Physician of Record
    text
    C25191 (NCI Thesaurus ValueDomain)
    C2826892 (UMLS CUI-1)
    C25364 (NCI Thesaurus Property)
    C17089 (NCI Thesaurus ObjectClass)
    C25644 (NCI Thesaurus ObjectClass-2)
    Medical Record Number
    Item
    Patient Medical Record Number
    text
    C25337 (NCI Thesaurus ValueDomain)
    C1301894 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C25261 (NCI Thesaurus Property)
    C25198 (NCI Thesaurus Property-2)
    Person Completing Form Last Name
    Item
    Last name
    text
    C25190 (NCI Thesaurus ObjectClass)
    C1550483 (UMLS CUI-1)
    C25657 (NCI Thesaurus ObjectClass-2)
    C1301584 (UMLS CUI-2)
    C25364 (NCI Thesaurus Property)
    C25551 (NCI Thesaurus Property-2)
    C25191 (NCI Thesaurus ValueDomain)
    Person Completing Form First Name
    Item
    First Name
    text
    C25190 (NCI Thesaurus ObjectClass)
    C1550483 (UMLS CUI-1)
    C25657 (NCI Thesaurus ObjectClass-2)
    C1443235 (UMLS CUI-2)
    C25364 (NCI Thesaurus Property)
    C25509 (NCI Thesaurus Property-2)
    C25191 (NCI Thesaurus ValueDomain)
    Person Completing Form Phone
    Item
    Phone
    text
    C25337 (NCI Thesaurus ValueDomain)
    C1550483 (UMLS CUI-1)
    C25190 (NCI Thesaurus ObjectClass)
    C1515258 (UMLS CUI-2)
    C25657 (NCI Thesaurus ObjectClass-2)
    C25395 (NCI Thesaurus Property)
    ResponsiblePersonFaxNumber
    Item
    Fax
    text
    C25337 (NCI Thesaurus ValueDomain)
    C0237753 (UMLS 2011AA ValueDomain)
    C25190 (NCI Thesaurus ObjectClass)
    C0027361 (UMLS 2011AA ObjectClass)
    C25657 (NCI Thesaurus ObjectClass-2)
    C1273518 (UMLS 2011AA ObjectClass-2)
    C25210 (NCI Thesaurus Property)
    C0085205 (UMLS 2011AA Property)
    ResponsiblePersonE-mailAddressText
    Item
    E-mail
    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)
    Item Group
    Patient Demographics / Pre-treatment Characteristics
    C1704791 (UMLS CUI-1)
    Patient Initials
    Item
    Patient Initials
    text
    C25191 (NCI Thesaurus ValueDomain)
    C2986440 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C25536 (NCI Thesaurus Property)
    Item
    Gender
    text
    C25372 (NCI Thesaurus ValueDomain)
    C0079399 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C17357 (NCI Thesaurus Property)
    CL.1
    Code List
    Gender
    CL Item
    Male (MALE)
    C46109 (NCI Thesaurus)
    C1706180 (UMLS 2011AA)
    CL Item
    Female (FEMALE)
    C46110 (NCI Thesaurus)
    C0015780 (UMLS 2011AA)
    CL Item
    Unknown (UNKNOWN)
    C17998 (NCI Thesaurus)
    C0439673 (UMLS 2011AA)
    PersonBirthDate
    Item
    Date of Birth
    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)
    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)
    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)
    Item
    Method of Payment (check oneUSA only)
    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)
    CL.2
    Code List
    Method of Payment (check oneUSA only)
    CL Item
    Private Insurance (Private Insurance)
    CL Item
    Medicare (Medicare)
    C16665 (NCI Thesaurus)
    C0018717 (UMLS 2011AA)
    CL Item
    Medicare And Private Insurance (Medicare and Private Insurance)
    CL Item
    Medicaid (Medicaid)
    C0025071 (NCI Metathesaurus)
    CL Item
    Medicaid And Medicare (Medicaid and Medicare)
    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
    Veterans Sponsored (Veterans Sponsored)
    CL Item
    Self Pay (no Insurance) (Self Pay (No Insurance))
    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
    Unknown (Unknown)
    C17998 (NCI Thesaurus)
    C0439673 (UMLS 2011AA)
    Item
    Race
    text
    C25372 (NCI Thesaurus ValueDomain)
    C0034510 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C17049 (NCI Thesaurus Property)
    CL.3
    Code List
    Race
    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
    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 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 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
    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
    Ethnicity
    text
    C25372 (NCI Thesaurus ValueDomain)
    C0015031 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C16564 (NCI Thesaurus Property)
    CL.4
    Code List
    Ethnicity
    CL Item
    A Person Not Meeting The Definition For Hispanic Or Latino. (NOT HISPANIC OR LATINO)
    C41222 (NCI Thesaurus)
    C1518424 (UMLS 2011AA)
    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
    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 Group
    Unnamed 1
    PatientNorthCentralCancerTreatmentGroupIdentifierNumber
    Item
    NCCTG Patient ID
    text
    C25337 (NCI Thesaurus ValueDomain)
    C0237753 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    C25581 (NCI Thesaurus Property-2)
    C1518419 (UMLS 2011AA Property-2)
    Item Group
    Intensity modulated radiation therapy
    C1512814 (UMLS CUI-1)
    IMRT usage
    Item
    Is your site using IMRT for this study?
    boolean
    C38148 (NCI Thesaurus ValueDomain)
    C16135 (NCI Thesaurus Property)
    C41206 (NCI Thesaurus ObjectClass)
    C25409 (NCI Thesaurus Property-2)
    C1512814 (UMLS CUI-1)
    IMRT Certification
    Item
    If yes, is your site certified?
    text
    C38148 (NCI Thesaurus ValueDomain)
    C16135 (NCI Thesaurus Property)
    C41206 (NCI Thesaurus ObjectClass)
    C43610 (NCI Thesaurus Property-2)
    C1512814 (UMLS CUI-1)
    C0007836 (UMLS CUI-2)
    Item Group
    Neurocognitive Testing Certification
    Person certified for neurocognitive testing
    Item
    Is at least one individual at your site certified for Neurocognitive testing
    boolean
    C25190 (NCI Thesaurus ObjectClass)
    C81313 (NCI Thesaurus Property)
    C41206 (NCI Thesaurus Property-2)
    C73925 (NCI Thesaurus Property-3)
    C38148 (NCI Thesaurus ValueDomain)
    C0027361 (UMLS CUI-1)
    C0027853 (UMLS CUI-2)
    C1272753 (UMLS CUI-3)
    C2362313 (UMLS CUI-4)
    Item Group
    Eligibility Check
    PathologySpecimenCentralReviewerSubmissionInd-2
    Item
    Central pathology review submission. This review is mandatory prior to registration to confirm eligibility. It should be initiated as soon after surgery as possible.
    boolean
    C19157 (NCI Thesaurus ObjectClass)
    C0370003 (UMLS 2011AA ObjectClass)
    C18189 (NCI Thesaurus ObjectClass-2)
    C0030664 (UMLS 2011AA ObjectClass-2)
    C25694 (NCI Thesaurus Property)
    C1515022 (UMLS 2011AA Property)
    C51807 (NCI Thesaurus Property-2)
    C1707338 (UMLS 2011AA Property-2)
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    TherapyBeginRequirementInd-2
    Item
    Treatment should begin >=2 weeks and <=5 weeks following surgery
    boolean
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    C15368 (NCI Thesaurus ObjectClass)
    C25431 (NCI Thesaurus Property)
    C0439659 (UMLS 2011AA Property)
    C38015 (NCI Thesaurus Property-2)
    Item Group
    Pre-registration Check
    InformedConsentFormSignedInd-2
    Item
    Consent form signed and dated
    boolean
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    C16468 (NCI Thesaurus ObjectClass)
    C0009797 (UMLS 2011AA ObjectClass)
    C25679 (NCI Thesaurus Property)
    InformedConsentFormSignedDate
    Item
    Date Informed Consent Signed
    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)
    Item
    Authorization for use and disclosure of protected health information signed and dated (If not a USA institution check NA)
    text
    C25180 (NCI Thesaurus ValueDomain)
    C1522602 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25178 (NCI Thesaurus Property)
    C0018684 (UMLS 2011AA Property)
    CL.11
    Code List
    Authorization for use and disclosure of protected health information signed and dated (If not a USA institution check NA)
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Not Applicable (NA)
    C48660 (NCI Thesaurus)
    C1272460 (UMLS 2011AA)
    C48660 (NCI Thesaurus-3)
    C1272460 (UMLS 2011AA-4)
    HealthInsurancePortabilityandAccountabilityActTissueDonorAuthorizationDate
    Item
    Date of authorization (If a USA institution)
    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)
    CentralPathologyReviewPriorRandomizationRequirementInd-2
    Item
    The site has reviewed and understands the process listed in Section 17.0 and must account for sufficient time to complete pre-registration and registration steps
    boolean
    C71684 (NCI Thesaurus ObjectClass)
    C2347585 (UMLS 2011AA ObjectClass)
    C25196 (NCI Thesaurus Property)
    C0034656 (UMLS 2011AA Property)
    C25629 (NCI Thesaurus Property-2)
    C0332152 (UMLS 2011AA Property-2)
    C25652 (NCI Thesaurus Property-3)
    C1514873 (UMLS 2011AA Property-3)
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    Radiation oncologist confirmed patient eligibility
    Item
    An NCCTG or ABTC approved radiation oncologist has seen the patient and confirms the patient is a suitable candidate for this study
    text
    C38148 (NCI Thesaurus ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C25171 (NCI Thesaurus Property)
    C0030705 (UMLS CUI-1)
    C0013893 (UMLS CUI-2)
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