ID

43120

Beschrijving

N107C Pre-Registration (Step 1) Form and Eligibility Checklist Stereotactic Radiosurgery or Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases That Have Been Removed By Surgery Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A06D80B4-4143-B9BC-E040-BB89AD437EB8

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A06D80B4-4143-B9BC-E040-BB89AD437EB8

Trefwoorden

  1. 18-12-14 18-12-14 - Martin Dugas
  2. 20-09-21 20-09-21 -
Geüploaded op

20 september 2021

DOI

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Licentie

Creative Commons BY-NC 3.0 Legacy

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Cognitive/Functional Effects NCT01372774 Eligibility - N107C Pre-Registration (Step 1) Form and Eligibility Checklist - 3226376v1.0

No Instruction available.

  1. StudyEvent: N107C Pre-Registration (Step 1) Form and Eligibility Checklist
    1. No Instruction available.
Required Characteristics
Beschrijving

Required Characteristics

Four or fewer brain metastases (as defined on the preoperative MRI brain scan) and status post resection of one of the lesions
Beschrijving

BrainMetastasisPresentInd-3

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus ObjectClass
C12439
UMLS 2011AA ObjectClass
C0006104
NCI Thesaurus ObjectClass
C19151
UMLS 2011AA ObjectClass
C0027627
Pathology from the resected brain metastasis must be consistent with a non-central nervous system primary site (NOTE: Patients with or without active disease outside the nervous system are eligible including patients with unknown primaries, as long as the pathology from the brain is consistent with a non-central nervous system primary site.)
Beschrijving

PatientBrainMetastasisClinicalTrialEligibilityCriteriaInd-2

Datatype

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C12439
UMLS 2011AA Property
C0006104
NCI Thesaurus Property
C19151
UMLS 2011AA Property
C0027627
NCI Thesaurus Property
C16112
UMLS 2011AA Property
C1516637
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Any unresected lesions must measure <=3.0 cm in maximal extent on the contrasted preoperative treatment MRI brain scan obtained <=35 days prior to pre-registration (see Magnetic Resonance Imaging Guidelines, Section 11.2). The unresected lesions will be treated with SRS as outlined in the treatment section (Section 7.0) of the protocol. (NOTE: The metastases size restriction does not apply to the resected brain metastasis; with resected brain metastasis only surgical cavity size determines eligibility see 3.114)
Beschrijving

PatientBrainLesionClinicalTrialEligibilityCriteriaInd-2

Datatype

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C3824
UMLS 2011AA Property
C0221198
NCI Thesaurus Property
C12439
UMLS 2011AA Property
C0006104
NCI Thesaurus Property
C16112
UMLS 2011AA Property
C1516637
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Resection cavity must measure <5.0 cm in maximal extent on the postoperative MRI (or CT) brain scan obtained <=35 days prior to pre-registration (NOTE: It is permissible for the resection of a dominant brain metastasis to include a smaller "satellite" metastasis as long as the single resection cavity is less than the maximum size requirements.)
Beschrijving

PatientBrainLesionResectedClinicalTrialEligibilityCriteriaInd-2

Datatype

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C3824
UMLS 2011AA Property
C0221198
NCI Thesaurus Property
C12439
UMLS 2011AA Property
C0006104
NCI Thesaurus Property
C25654
UMLS 2011AA Property
C1521996
NCI Thesaurus Property
C16112
UMLS 2011AA Property
C1516637
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
All standard tumor-staging procedures necessary to define baseline extracranial disease status completed <=42 days prior to pre-registration
Beschrijving

PatientBrainMetastasisStagingClinicalTrialEligibilityCriteriaInd-2

Datatype

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C12439
UMLS 2011AA Property
C0006104
NCI Thesaurus Property
C19151
UMLS 2011AA Property
C0027627
NCI Thesaurus Property
C15608
UMLS 2011AA Property
C0332305
NCI Thesaurus Property
C16112
UMLS 2011AA Property
C1516637
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Ability to be treated with either a gamma knife or a linear accelerator-based radiosurgery system
Beschrijving

RadiationSurgeryLinearAcceleratorGammaKnifeDeviceUnitInd-3

Datatype

text

Alias
NCI Thesaurus ObjectClass
C15696
UMLS 2011AA ObjectClass
C0085203
NCI Thesaurus Property
C28169
UMLS 2011AA Property
C0023730
NCI Thesaurus Property
C15382
UMLS 2011AA Property
C0086330
NCI Thesaurus Property
C50329
UMLS 2011AA Property
C1509845
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Age >= 18 years
Beschrijving

PatientAgeInd-2

Datatype

text

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
Age (=)
Beschrijving

PatientAgeValue

Datatype

double

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25150
UMLS 2011AA Property
C0001779
Willing and able to complete neurocognitive examination without assistance
Beschrijving

NeurologicCognitiveAssessmentCompleteInd-3b

Datatype

text

Alias
NCI Thesaurus ObjectClass
C20989
UMLS 2011AA ObjectClass
C0031809
NCI Thesaurus ObjectClass
C25262
UMLS 2011AA ObjectClass
C0205494
NCI Thesaurus ObjectClass
C37926
UMLS 2011AA ObjectClass
C1516691
NCI Thesaurus Property
C25250
UMLS 2011AA Property
C0205197
NCI Metathesaurus ValueDomain
CL355214
Willing and able to complete QOL by themselves or with assistance (see Section 4.0)
Beschrijving

PatientQuestionnaireCompleteEligibilityDeterminationInd-2

Datatype

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25250
UMLS 2011AA Property
C0205197
NCI Thesaurus Property
C17048
UMLS 2011AA Property
C0034394
NCI Thesaurus Property
C25171
UMLS 2011AA Property
C0013893
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
ECOG performance status (PS) 0, 1, or 2
Beschrijving

EasternCooperativeOncologyGroupPerformanceStatusAssessmentInd-2

Datatype

text

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 (=)
Beschrijving

PerformanceStatusAssessmentEasternCooperativeOncologyGroupScale

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS 2011AA ValueDomain
C0349674
NCI Thesaurus Property
C25367
NCI Thesaurus ValueDomain
C25491
UMLS 2011AA ValueDomain
C1512162
NCI Thesaurus ObjectClass
C20641
UMLS 2011AA ObjectClass
C1518965
SRS facility is Radiological Physics Center (RPC) approved (see Section 6.24)
Beschrijving

RadiationTherapyCredentialStereotacticRadiosurgeryInstitutionInd-3

Datatype

text

Alias
NCI Thesaurus ObjectClass
C15313
UMLS 2011AA ObjectClass
C1522449
NCI Thesaurus Property
C15358
UMLS 2011AA Property
C0085203
NCI Thesaurus Property
C41206
UMLS 2011AA Property
C1272753
NCI Thesaurus Property
C73925
UMLS 2011AA Property
C2362313
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
The Neurocognitive Testing examiner must have credentialing confirming completion of the neurocognitive testing training (see Section 6.25)
Beschrijving

PersonCredentialNeurologicExaminationInstitutionInd-3

Datatype

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C81313
UMLS 2011AA Property
C0027853
NCI Thesaurus Property
C41206
UMLS 2011AA Property
C1272753
NCI Thesaurus Property
C73925
UMLS 2011AA Property
C2362313
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Provide informed written consent
Beschrijving

PatientConsentAbilityInd-2

Datatype

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25460
UMLS 2011AA Property
C1511481
NCI Thesaurus Property
C78209
UMLS 2011AA Property
C0085732
Willing to provide blood and urine samples for correlative research purposes (see Sections 6.0 and 14.0)
Beschrijving

PersonSpecimenUseConsentEligibilityDeterminationIndicator

Datatype

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C19157
UMLS 2011AA Property
C0370003
NCI Thesaurus Property
C25171
UMLS 2011AA Property
C0013893
NCI Thesaurus Property
C25460
UMLS 2011AA Property
C1511481
NCI Thesaurus Property
C25340
UMLS 2011AA Property
C0457083
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
Pre-registration Exclusion Criteria
Beschrijving

Pre-registration Exclusion Criteria

Any of the following: Pregnant women Nursing women Men or women of childbearing potential who are unwilling to employ adequate contraception throughout the study and for men for up to 3 months after completing treatment
Beschrijving

PatientPhysicalExaminationPregnancyBreastFeedingContraindicatedInd-2

Datatype

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ObjectClass
C20989
UMLS 2011AA ObjectClass
C0031809
NCI Thesaurus Property
C25742
UMLS 2011AA Property
C0032961
NCI Thesaurus Property
C37933
UMLS 2011AA Property
C1444657
NCI Thesaurus Property
C25596
UMLS 2011AA Property
C0006147
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Prior cranial RT (radiation therapy)
Beschrijving

PriorCranialRadiationTherapyAdministeredInd-2

Datatype

text

Alias
NCI Thesaurus ObjectClass
C15313
UMLS 2011AA ObjectClass
C1522449
NCI Thesaurus ObjectClass
C25629
UMLS 2011AA ObjectClass
C0332152
NCI Thesaurus ObjectClass
C37936
UMLS 2011AA ObjectClass
C0205096
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Inability to complete an MRI with contrast of the head
Beschrijving

DiagnosticImagingNotPerformedInd-3

Datatype

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C16502
UMLS 2011AA ObjectClass
C0011923
NCI Thesaurus Property
C25594
UMLS 2011AA Property
C1518422
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
Known allergy to gadolinium
Beschrijving

PatientClinicalStudyAgentHypersensitivityPersonalMedicalHistoryInd-2

Datatype

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C3114
UMLS 2011AA Property
C0020517
NCI Thesaurus Property
C1708
UMLS 2011AA Property
C0450442
NCI Thesaurus Property
C15206
UMLS 2011AA Property
C0008972
NCI Thesaurus Property
C18772
UMLS 2011AA Property
C0262926
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Planned cytotoxic chemotherapy during the SRS and WBRT
Beschrijving

PatientInvestigationalClinicalTrialCurrentParticipationExclusionCriteriaInd-2

Datatype

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25608
UMLS 2011AA Property
C0679823
NCI Thesaurus Property
C25471
UMLS 2011AA Property
C0521116
NCI Thesaurus Property
C15207
NCI Thesaurus Property
C28041
UMLS 2011AA Property
C1517586
NCI Thesaurus Property
C25370
UMLS 2011AA Property
C0680251
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Primary germ cell tumor, small cell carcinoma, or lymphoma
Beschrijving

PatientConcurrentSystemicDiseaseorDisorderExclusionCriteriaInd-2

Datatype

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C13310
UMLS 2011AA Property
C0205373
NCI Thesaurus Property
C2991
UMLS 2011AA Property
C0012634
NCI Thesaurus Property
C25456
UMLS 2011AA Property
C0205420
NCI Thesaurus Property
C25370
UMLS 2011AA Property
C0680251
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Widespread definitive leptomeningeal metastasis
Beschrijving

PatientMetastaticMalignantNeoplasmtotheBrainExclusionCriteriaInd-2

Datatype

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C3813
UMLS 2011AA Property
C0220650
NCI Thesaurus Property
C25370
UMLS 2011AA Property
C0680251
A brain metastasis that is located <=5 mm of the optic chiasm or within the brainstem
Beschrijving

PatientCentralNervousSystemDiseaseorDisorderEligibilityDeterminationInd-2

Datatype

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C12438
UMLS 2011AA Property
C3714787
NCI Thesaurus Property
C2991
UMLS 2011AA Property
C0012634
NCI Thesaurus Property
C25171
UMLS 2011AA Property
C0013893
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Pre-registration Check
Beschrijving

Pre-registration Check

Consent form signed and dated
Beschrijving

InformedConsentFormSignedInd-2

Datatype

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16468
UMLS 2011AA ObjectClass
C0009797
NCI Thesaurus Property
C25679
Date Informed Consent Signed (mm/dd/yyyy)
Beschrijving

InformedConsentFormSignedDate

Datatype

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
C25367
NCI Thesaurus ObjectClass
C16468
UMLS 2011AA ObjectClass
C0009797
NCI Thesaurus Property
C25679
Authorization for use and disclosure of protected health information signed and dated (Non-USA institution only check NA)
Beschrijving

PatientHealthRecordIndicator

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25178
UMLS 2011AA Property
C0018684
Date of authorization (mm/dd/yyyy)
Beschrijving

HealthInsurancePortabilityandAccountabilityActTissueDonorAuthorizationDate

Datatype

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
C41192
UMLS 2011AA Property
C1524004
A mandatory correlative research component for blood and urine is part of this study; the patient will be automatically registered onto this component (see Sections 3.119f and 14.0)
Beschrijving

PatientRegisteredInd-2

Datatype

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25644
Pre-registration tests/procedures must be completed <=14 days prior to pre-registration (see Section 4.0)
Beschrijving

PatientPriorRegistrationLaboratoryProcedureVerificationInd-2

Datatype

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25646
UMLS 2011AA Property
C1514821
NCI Thesaurus Property
C25629
UMLS 2011AA Property
C0332152
NCI Thesaurus Property
C25294
UMLS 2011AA Property
C0022885
NCI Thesaurus Property
C45513
UMLS 2011AA Property
C1711411
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Earliest pre-registration test date (mm/dd/yyyy NOTE: The earliest pre-registration test date must be less than or equal to the latest pre-registration test date. The above dates DO NOT include footnote 9 of the test schedule that reads "All standard tumor-staging procedures necessary to define baseline extracranial status as deemed appropriate by the treating oncology physician completed <=42 days prior to pre-registration.")
Beschrijving

PatientPriorRegistrationLaboratoryProcedureEligibilityDeterminationBeginDate

Datatype

date

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25646
UMLS 2011AA Property
C1514821
NCI Thesaurus Property
C25629
UMLS 2011AA Property
C0332152
NCI Thesaurus Property
C25294
UMLS 2011AA Property
C0022885
NCI Thesaurus Property
C25171
UMLS 2011AA Property
C0013893
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
C25431
UMLS 2011AA ValueDomain
C0439659
Latest pre-registration test date (mm/dd/yyyy)
Beschrijving

PatientPriorRegistrationLaboratoryProcedureEligibilityDeterminationEndDate

Datatype

date

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25646
UMLS 2011AA Property
C1514821
NCI Thesaurus Property
C25629
UMLS 2011AA Property
C0332152
NCI Thesaurus Property
C25294
UMLS 2011AA Property
C0022885
NCI Thesaurus Property
C25171
UMLS 2011AA Property
C0013893
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
All required baseline symptoms (see Section 10.3) must be documented and graded
Beschrijving

ClinicalTrialBaselineDiseaseDocumentedChecklistInd-2

Datatype

text

Alias
NCI Thesaurus ObjectClass
C15207
NCI Thesaurus Property
C25213
UMLS 2011AA Property
C1442488
NCI Thesaurus Property
C2991
UMLS 2011AA Property
C0012634
NCI Thesaurus Property
C25356
UMLS 2011AA Property
C1301725
NCI Thesaurus Property
C49073
UMLS 2011AA Property
C1707357
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
A radiation oncologist has seen the patient and confirms the patient is a suitable candidate for this study
Beschrijving

RadiationOncologistConsultationPerformedInd-3

Datatype

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus ObjectClass
C17833
UMLS 2011AA ObjectClass
C1514693
NCI Thesaurus Property
C41188
UMLS 2011AA Property
C0009818
Blood/urine kits available on site
Beschrijving

ClinicalTrialBloodSpecimenCollectionAvailabilityChecklistInd-2

Datatype

text

Alias
NCI Thesaurus ObjectClass
C15207
NCI Thesaurus Property
C12434
UMLS 2011AA Property
C0229664
NCI Thesaurus Property
C25453
UMLS 2011AA Property
C1516698
NCI Thesaurus Property
C19157
UMLS 2011AA Property
C0370003
NCI Thesaurus Property
C25429
UMLS 2011AA Property
C0470187
NCI Thesaurus Property
C49073
UMLS 2011AA Property
C1707357
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Patient Questionnaire Booklet-Quality of Life (QOL) and Patient and Examiner Questionnaire Booklet-Neurocognitive Evaluations are available on site; copies are not acceptable for this submission
Beschrijving

ProtocolQuestionnaireAvailableInd-2

Datatype

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C25320
UMLS 2011AA ObjectClass
C1507394
NCI Thesaurus ObjectClass
C17048
UMLS 2011AA ObjectClass
C0034394
NCI Thesaurus Property
C25429
UMLS 2011AA Property
C0470187
Ran
Beschrijving

Ran

Patient has given permission to store and use his/her blood samples for use in future research to learn about, prevent, or treat cancer
Beschrijving

BloodSpecimenMalignantNeoplasmRelatedResearchConsentIndicator

Datatype

text

Alias
NCI Thesaurus ObjectClass
C12434
UMLS 2011AA ObjectClass
C0229664
NCI Thesaurus ObjectClass
C19157
UMLS 2011AA ObjectClass
C0370003
NCI Thesaurus Property
C15319
NCI Thesaurus Property
C25648
UMLS 2011AA Property
C0439849
NCI Thesaurus Property
C9305
UMLS 2011AA Property
C0006826
NCI Thesaurus Property
C25460
UMLS 2011AA Property
C1511481
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
Patient has given permission to store and use his/her blood samples for use in future research to learn about, prevent, or treat other health problems (for example: diabetes, Alzheimer's disease, or heart disease.)
Beschrijving

BloodSpecimenOtherDiseasesandDisordersResearchConsentInd-3

Datatype

text

Alias
NCI Thesaurus ObjectClass
C12434
UMLS 2011AA ObjectClass
C0229664
NCI Thesaurus ObjectClass
C19157
UMLS 2011AA ObjectClass
C0370003
NCI Thesaurus Property
C17649
UMLS 2011AA Property
C0205394
NCI Thesaurus Property
C15319
NCI Thesaurus Property
C2991
UMLS 2011AA Property
C0012634
NCI Thesaurus Property
C25460
UMLS 2011AA Property
C1511481
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Patient has given permission for NCCTG to give his/her stored blood samples for use in future research to outside researchers
Beschrijving

PatientOptionalConsentInd-2

Datatype

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25603
UMLS 2011AA Property
C1518600
NCI Thesaurus Property
C25460
UMLS 2011AA Property
C1511481
Patient has given permission to store and use his/her urine samples for use in future research to learn about, prevent, or treat cancer
Beschrijving

UrineSpecimenMalignantNeoplasmRelatedResearchConsentInd-3

Datatype

text

Alias
NCI Thesaurus ObjectClass
C13283
UMLS 2011AA ObjectClass
C0042036
NCI Thesaurus ObjectClass
C19157
UMLS 2011AA ObjectClass
C0370003
NCI Thesaurus Property
C15319
NCI Thesaurus Property
C25648
UMLS 2011AA Property
C0439849
NCI Thesaurus Property
C9305
UMLS 2011AA Property
C0006826
NCI Thesaurus Property
C25460
UMLS 2011AA Property
C1511481
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Patient has given permission to store and use his/her urine samples for use in future research to learn about, prevent, or treat other health problems (for example: diabetes, Alzheimer's disease, or heart disease.)
Beschrijving

UrineSpecimenOtherDiseaseorDisorderConsentInd-3

Datatype

text

Alias
NCI Thesaurus ObjectClass
C13283
UMLS 2011AA ObjectClass
C0042036
NCI Thesaurus ObjectClass
C19157
UMLS 2011AA ObjectClass
C0370003
NCI Thesaurus Property
C17649
UMLS 2011AA Property
C0205394
NCI Thesaurus Property
C2991
UMLS 2011AA Property
C0012634
NCI Thesaurus Property
C25460
UMLS 2011AA Property
C1511481
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Patient has given permission for NCCTG to give his/her stored urine samples for use in future research to outside researchers
Beschrijving

PersonSpecimenExternalInvestigatorConsentInd-2

Datatype

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C44280
UMLS 2011AA Property
C0205101
NCI Thesaurus Property
C19157
UMLS 2011AA Property
C0370003
NCI Thesaurus Property
C25936
UMLS 2011AA Property
C0035173
NCI Thesaurus Property
C25460
UMLS 2011AA Property
C1511481
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Patient has given permission to store and use his/her tissue samples for use in future research to learn about, prevent, or treat cancer
Beschrijving

PersonSpecimenMalignantNeoplasmResearchConsentInd-2

Datatype

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C15319
NCI Thesaurus Property
C9305
UMLS 2011AA Property
C0006826
NCI Thesaurus Property
C19157
UMLS 2011AA Property
C0370003
NCI Thesaurus Property
C25460
UMLS 2011AA Property
C1511481
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Patient has given permission to store and use his/her tissue samples for use in future research to learn about, prevent, or treat other health problems (for example: diabetes, Alzheimer's disease, or heart disease.)
Beschrijving

BloodTissueSpecimenOtherDiseasesandDisordersResearchConsentInd-3

Datatype

text

Alias
NCI Thesaurus ObjectClass
C12801
UMLS 2011AA ObjectClass
C0040300
NCI Thesaurus ObjectClass
C12434
UMLS 2011AA ObjectClass
C0229664
NCI Thesaurus ObjectClass
C19157
UMLS 2011AA ObjectClass
C0370003
NCI Thesaurus Property
C17649
UMLS 2011AA Property
C0205394
NCI Thesaurus Property
C15319
NCI Thesaurus Property
C2991
UMLS 2011AA Property
C0012634
NCI Thesaurus Property
C25460
UMLS 2011AA Property
C1511481
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Patient has given permission for NCCTG to give his/her stored tissue samples for use in future research to outside researchers
Beschrijving

TissueSpecimenMalignantNeoplasmRelatedResearchConsentInd-3

Datatype

text

Alias
NCI Thesaurus ObjectClass
C12801
UMLS 2011AA ObjectClass
C0040300
NCI Thesaurus ObjectClass
C19157
UMLS 2011AA ObjectClass
C0370003
NCI Thesaurus Property
C15319
NCI Thesaurus Property
C25648
UMLS 2011AA Property
C0439849
NCI Thesaurus Property
C9305
UMLS 2011AA Property
C0006826
NCI Thesaurus Property
C25460
UMLS 2011AA Property
C1511481
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699

Similar models

No Instruction available.

  1. StudyEvent: N107C Pre-Registration (Step 1) Form and Eligibility Checklist
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item
Four or fewer brain metastases (as defined on the preoperative MRI brain scan) and status post resection of one of the lesions
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C12439 (NCI Thesaurus ObjectClass)
C0006104 (UMLS 2011AA ObjectClass)
C19151 (NCI Thesaurus ObjectClass)
C0027627 (UMLS 2011AA ObjectClass)
Code List
Four or fewer brain metastases (as defined on the preoperative MRI brain scan) and status post resection of one of the lesions
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Pathology from the resected brain metastasis must be consistent with a non-central nervous system primary site (NOTE: Patients with or without active disease outside the nervous system are eligible including patients with unknown primaries, as long as the pathology from the brain is consistent with a non-central nervous system primary site.)
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C12439 (NCI Thesaurus Property)
C0006104 (UMLS 2011AA Property)
C19151 (NCI Thesaurus Property)
C0027627 (UMLS 2011AA Property)
C16112 (NCI Thesaurus Property)
C1516637 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Code List
Pathology from the resected brain metastasis must be consistent with a non-central nervous system primary site (NOTE: Patients with or without active disease outside the nervous system are eligible including patients with unknown primaries, as long as the pathology from the brain is consistent with a non-central nervous system primary site.)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Any unresected lesions must measure <=3.0 cm in maximal extent on the contrasted preoperative treatment MRI brain scan obtained <=35 days prior to pre-registration (see Magnetic Resonance Imaging Guidelines, Section 11.2). The unresected lesions will be treated with SRS as outlined in the treatment section (Section 7.0) of the protocol. (NOTE: The metastases size restriction does not apply to the resected brain metastasis; with resected brain metastasis only surgical cavity size determines eligibility see 3.114)
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C3824 (NCI Thesaurus Property)
C0221198 (UMLS 2011AA Property)
C12439 (NCI Thesaurus Property)
C0006104 (UMLS 2011AA Property)
C16112 (NCI Thesaurus Property)
C1516637 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Code List
Any unresected lesions must measure <=3.0 cm in maximal extent on the contrasted preoperative treatment MRI brain scan obtained <=35 days prior to pre-registration (see Magnetic Resonance Imaging Guidelines, Section 11.2). The unresected lesions will be treated with SRS as outlined in the treatment section (Section 7.0) of the protocol. (NOTE: The metastases size restriction does not apply to the resected brain metastasis; with resected brain metastasis only surgical cavity size determines eligibility see 3.114)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Resection cavity must measure <5.0 cm in maximal extent on the postoperative MRI (or CT) brain scan obtained <=35 days prior to pre-registration (NOTE: It is permissible for the resection of a dominant brain metastasis to include a smaller "satellite" metastasis as long as the single resection cavity is less than the maximum size requirements.)
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C3824 (NCI Thesaurus Property)
C0221198 (UMLS 2011AA Property)
C12439 (NCI Thesaurus Property)
C0006104 (UMLS 2011AA Property)
C25654 (NCI Thesaurus Property)
C1521996 (UMLS 2011AA Property)
C16112 (NCI Thesaurus Property)
C1516637 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Code List
Resection cavity must measure <5.0 cm in maximal extent on the postoperative MRI (or CT) brain scan obtained <=35 days prior to pre-registration (NOTE: It is permissible for the resection of a dominant brain metastasis to include a smaller "satellite" metastasis as long as the single resection cavity is less than the maximum size requirements.)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
All standard tumor-staging procedures necessary to define baseline extracranial disease status completed <=42 days prior to pre-registration
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C12439 (NCI Thesaurus Property)
C0006104 (UMLS 2011AA Property)
C19151 (NCI Thesaurus Property)
C0027627 (UMLS 2011AA Property)
C15608 (NCI Thesaurus Property)
C0332305 (UMLS 2011AA Property)
C16112 (NCI Thesaurus Property)
C1516637 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Code List
All standard tumor-staging procedures necessary to define baseline extracranial disease status completed <=42 days prior to pre-registration
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Ability to be treated with either a gamma knife or a linear accelerator-based radiosurgery system
text
C15696 (NCI Thesaurus ObjectClass)
C0085203 (UMLS 2011AA ObjectClass)
C28169 (NCI Thesaurus Property)
C0023730 (UMLS 2011AA Property)
C15382 (NCI Thesaurus Property)
C0086330 (UMLS 2011AA Property)
C50329 (NCI Thesaurus Property)
C1509845 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
Code List
Ability to be treated with either a gamma knife or a linear accelerator-based radiosurgery system
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Age >= 18 years
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25150 (NCI Thesaurus Property)
C0001779 (UMLS 2011AA Property)
Code List
Age >= 18 years
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
PatientAgeValue
Item
Age (=)
double
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25150 (NCI Thesaurus Property)
C0001779 (UMLS 2011AA Property)
Item
Willing and able to complete neurocognitive examination without assistance
text
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C25262 (NCI Thesaurus ObjectClass)
C0205494 (UMLS 2011AA ObjectClass)
C37926 (NCI Thesaurus ObjectClass)
C1516691 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
CL355214 (NCI Metathesaurus ValueDomain)
Code List
Willing and able to complete neurocognitive examination without assistance
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Willing and able to complete QOL by themselves or with assistance (see Section 4.0)
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C17048 (NCI Thesaurus Property)
C0034394 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Code List
Willing and able to complete QOL by themselves or with assistance (see Section 4.0)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
ECOG performance status (PS) 0, 1, or 2
text
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)
Code List
ECOG performance status (PS) 0, 1, or 2
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
ECOG Performance Status (=)
text
C25664 (NCI Thesaurus ValueDomain)
C0349674 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus Property)
C25491 (NCI Thesaurus ValueDomain)
C1512162 (UMLS 2011AA ValueDomain)
C20641 (NCI Thesaurus ObjectClass)
C1518965 (UMLS 2011AA ObjectClass)
Code List
ECOG Performance Status (=)
CL Item
Fully Active, Able To Carry On All Pre-disease Performance Without Restriction. (0)
CL Item
Restricted In Physically Strenuous Activity But Ambulatory And Able To Carry Out Work Of A Light Or Sedentary Nature, E.g., Light Housework, Office Work. (1)
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)
Item
SRS facility is Radiological Physics Center (RPC) approved (see Section 6.24)
text
C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C15358 (NCI Thesaurus Property)
C0085203 (UMLS 2011AA Property)
C41206 (NCI Thesaurus Property)
C1272753 (UMLS 2011AA Property)
C73925 (NCI Thesaurus Property)
C2362313 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
Code List
SRS facility is Radiological Physics Center (RPC) approved (see Section 6.24)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
The Neurocognitive Testing examiner must have credentialing confirming completion of the neurocognitive testing training (see Section 6.25)
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C81313 (NCI Thesaurus Property)
C0027853 (UMLS 2011AA Property)
C41206 (NCI Thesaurus Property)
C1272753 (UMLS 2011AA Property)
C73925 (NCI Thesaurus Property)
C2362313 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
Code List
The Neurocognitive Testing examiner must have credentialing confirming completion of the neurocognitive testing training (see Section 6.25)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Provide informed written consent
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25460 (NCI Thesaurus Property)
C1511481 (UMLS 2011AA Property)
C78209 (NCI Thesaurus Property)
C0085732 (UMLS 2011AA Property)
Code List
Provide informed written consent
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Willing to provide blood and urine samples for correlative research purposes (see Sections 6.0 and 14.0)
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus Property)
C0370003 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
C25460 (NCI Thesaurus Property)
C1511481 (UMLS 2011AA Property)
C25340 (NCI Thesaurus Property)
C0457083 (UMLS 2011AA Property)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
Code List
Willing to provide blood and urine samples for correlative research purposes (see Sections 6.0 and 14.0)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item Group
Pre-registration Exclusion Criteria
Item
Any of the following: Pregnant women Nursing women Men or women of childbearing potential who are unwilling to employ adequate contraception throughout the study and for men for up to 3 months after completing treatment
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C25742 (NCI Thesaurus Property)
C0032961 (UMLS 2011AA Property)
C37933 (NCI Thesaurus Property)
C1444657 (UMLS 2011AA Property)
C25596 (NCI Thesaurus Property)
C0006147 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Code List
Any of the following: Pregnant women Nursing women Men or women of childbearing potential who are unwilling to employ adequate contraception throughout the study and for men for up to 3 months after completing treatment
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Prior cranial RT (radiation therapy)
text
C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C37936 (NCI Thesaurus ObjectClass)
C0205096 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Code List
Prior cranial RT (radiation therapy)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Inability to complete an MRI with contrast of the head
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C16502 (NCI Thesaurus ObjectClass)
C0011923 (UMLS 2011AA ObjectClass)
C25594 (NCI Thesaurus Property)
C1518422 (UMLS 2011AA Property)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
Code List
Inability to complete an MRI with contrast of the head
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Known allergy to gadolinium
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C3114 (NCI Thesaurus Property)
C0020517 (UMLS 2011AA Property)
C1708 (NCI Thesaurus Property)
C0450442 (UMLS 2011AA Property)
C15206 (NCI Thesaurus Property)
C0008972 (UMLS 2011AA Property)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Code List
Known allergy to gadolinium
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Planned cytotoxic chemotherapy during the SRS and WBRT
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25608 (NCI Thesaurus Property)
C0679823 (UMLS 2011AA Property)
C25471 (NCI Thesaurus Property)
C0521116 (UMLS 2011AA Property)
C15207 (NCI Thesaurus Property)
C28041 (NCI Thesaurus Property)
C1517586 (UMLS 2011AA Property)
C25370 (NCI Thesaurus Property)
C0680251 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Code List
Planned cytotoxic chemotherapy during the SRS and WBRT
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Primary germ cell tumor, small cell carcinoma, or lymphoma
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C13310 (NCI Thesaurus Property)
C0205373 (UMLS 2011AA Property)
C2991 (NCI Thesaurus Property)
C0012634 (UMLS 2011AA Property)
C25456 (NCI Thesaurus Property)
C0205420 (UMLS 2011AA Property)
C25370 (NCI Thesaurus Property)
C0680251 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Code List
Primary germ cell tumor, small cell carcinoma, or lymphoma
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Widespread definitive leptomeningeal metastasis
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C3813 (NCI Thesaurus Property)
C0220650 (UMLS 2011AA Property)
C25370 (NCI Thesaurus Property)
C0680251 (UMLS 2011AA Property)
Code List
Widespread definitive leptomeningeal metastasis
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
A brain metastasis that is located <=5 mm of the optic chiasm or within the brainstem
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C12438 (NCI Thesaurus Property)
C3714787 (UMLS 2011AA Property)
C2991 (NCI Thesaurus Property)
C0012634 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Code List
A brain metastasis that is located <=5 mm of the optic chiasm or within the brainstem
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item Group
Pre-registration Check
Item
Consent form signed and dated
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16468 (NCI Thesaurus ObjectClass)
C0009797 (UMLS 2011AA ObjectClass)
C25679 (NCI Thesaurus Property)
Code List
Consent form signed and dated
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
InformedConsentFormSignedDate
Item
Date Informed Consent Signed (mm/dd/yyyy)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)
C16468 (NCI Thesaurus ObjectClass)
C0009797 (UMLS 2011AA ObjectClass)
C25679 (NCI Thesaurus Property)
Item
Authorization for use and disclosure of protected health information signed and dated (Non-USA institution only 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)
Code List
Authorization for use and disclosure of protected health information signed and dated (Non-USA institution only 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)
C1272460 (UMLS 2011AA)
HealthInsurancePortabilityandAccountabilityActTissueDonorAuthorizationDate
Item
Date of authorization (mm/dd/yyyy)
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)
C1524004 (UMLS 2011AA Property)
Item
A mandatory correlative research component for blood and urine is part of this study; the patient will be automatically registered onto this component (see Sections 3.119f and 14.0)
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25644 (NCI Thesaurus Property)
Code List
A mandatory correlative research component for blood and urine is part of this study; the patient will be automatically registered onto this component (see Sections 3.119f and 14.0)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Pre-registration tests/procedures must be completed <=14 days prior to pre-registration (see Section 4.0)
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25646 (NCI Thesaurus Property)
C1514821 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C45513 (NCI Thesaurus Property)
C1711411 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Code List
Pre-registration tests/procedures must be completed <=14 days prior to pre-registration (see Section 4.0)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
PatientPriorRegistrationLaboratoryProcedureEligibilityDeterminationBeginDate
Item
Earliest pre-registration test date (mm/dd/yyyy NOTE: The earliest pre-registration test date must be less than or equal to the latest pre-registration test date. The above dates DO NOT include footnote 9 of the test schedule that reads "All standard tumor-staging procedures necessary to define baseline extracranial status as deemed appropriate by the treating oncology physician completed <=42 days prior to pre-registration.")
date
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25646 (NCI Thesaurus Property)
C1514821 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain)
C0439659 (UMLS 2011AA ValueDomain)
PatientPriorRegistrationLaboratoryProcedureEligibilityDeterminationEndDate
Item
Latest pre-registration test date (mm/dd/yyyy)
date
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25646 (NCI Thesaurus Property)
C1514821 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
Item
All required baseline symptoms (see Section 10.3) must be documented and graded
text
C15207 (NCI Thesaurus ObjectClass)
C25213 (NCI Thesaurus Property)
C1442488 (UMLS 2011AA Property)
C2991 (NCI Thesaurus Property)
C0012634 (UMLS 2011AA Property)
C25356 (NCI Thesaurus Property)
C1301725 (UMLS 2011AA Property)
C49073 (NCI Thesaurus Property)
C1707357 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Code List
All required baseline symptoms (see Section 10.3) must be documented and graded
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
A radiation oncologist has seen the patient and confirms the patient is a suitable candidate for this study
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C17833 (NCI Thesaurus ObjectClass)
C1514693 (UMLS 2011AA ObjectClass)
C41188 (NCI Thesaurus Property)
C0009818 (UMLS 2011AA Property)
Code List
A radiation oncologist has seen the patient and confirms the patient is a suitable candidate for this study
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Blood/urine kits available on site
text
C15207 (NCI Thesaurus ObjectClass)
C12434 (NCI Thesaurus Property)
C0229664 (UMLS 2011AA Property)
C25453 (NCI Thesaurus Property)
C1516698 (UMLS 2011AA Property)
C19157 (NCI Thesaurus Property)
C0370003 (UMLS 2011AA Property)
C25429 (NCI Thesaurus Property)
C0470187 (UMLS 2011AA Property)
C49073 (NCI Thesaurus Property)
C1707357 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Code List
Blood/urine kits available on site
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Patient Questionnaire Booklet-Quality of Life (QOL) and Patient and Examiner Questionnaire Booklet-Neurocognitive Evaluations are available on site; copies are not acceptable for this submission
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C17048 (NCI Thesaurus ObjectClass)
C0034394 (UMLS 2011AA ObjectClass)
C25429 (NCI Thesaurus Property)
C0470187 (UMLS 2011AA Property)
Code List
Patient Questionnaire Booklet-Quality of Life (QOL) and Patient and Examiner Questionnaire Booklet-Neurocognitive Evaluations are available on site; copies are not acceptable for this submission
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Patient has given permission to store and use his/her blood samples for use in future research to learn about, prevent, or treat cancer
text
C12434 (NCI Thesaurus ObjectClass)
C0229664 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
C15319 (NCI Thesaurus Property)
C25648 (NCI Thesaurus Property)
C0439849 (UMLS 2011AA Property)
C9305 (NCI Thesaurus Property)
C0006826 (UMLS 2011AA Property)
C25460 (NCI Thesaurus Property)
C1511481 (UMLS 2011AA Property)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
Code List
Patient has given permission to store and use his/her blood samples for use in future research to learn about, prevent, or treat cancer
CL Item
Yes: C49488 (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No: C49487 (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Patient has given permission to store and use his/her blood samples for use in future research to learn about, prevent, or treat other health problems (for example: diabetes, Alzheimer's disease, or heart disease.)
text
C12434 (NCI Thesaurus ObjectClass)
C0229664 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C15319 (NCI Thesaurus Property)
C2991 (NCI Thesaurus Property)
C0012634 (UMLS 2011AA Property)
C25460 (NCI Thesaurus Property)
C1511481 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
Code List
Patient has given permission to store and use his/her blood samples for use in future research to learn about, prevent, or treat other health problems (for example: diabetes, Alzheimer's disease, or heart disease.)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Patient has given permission for NCCTG to give his/her stored blood samples for use in future research to outside researchers
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25603 (NCI Thesaurus Property)
C1518600 (UMLS 2011AA Property)
C25460 (NCI Thesaurus Property)
C1511481 (UMLS 2011AA Property)
Code List
Patient has given permission for NCCTG to give his/her stored blood samples for use in future research to outside researchers
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Patient has given permission to store and use his/her urine samples for use in future research to learn about, prevent, or treat cancer
text
C13283 (NCI Thesaurus ObjectClass)
C0042036 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
C15319 (NCI Thesaurus Property)
C25648 (NCI Thesaurus Property)
C0439849 (UMLS 2011AA Property)
C9305 (NCI Thesaurus Property)
C0006826 (UMLS 2011AA Property)
C25460 (NCI Thesaurus Property)
C1511481 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
Code List
Patient has given permission to store and use his/her urine samples for use in future research to learn about, prevent, or treat cancer
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Patient has given permission to store and use his/her urine samples for use in future research to learn about, prevent, or treat other health problems (for example: diabetes, Alzheimer's disease, or heart disease.)
text
C13283 (NCI Thesaurus ObjectClass)
C0042036 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C2991 (NCI Thesaurus Property)
C0012634 (UMLS 2011AA Property)
C25460 (NCI Thesaurus Property)
C1511481 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
Code List
Patient has given permission to store and use his/her urine samples for use in future research to learn about, prevent, or treat other health problems (for example: diabetes, Alzheimer's disease, or heart disease.)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Patient has given permission for NCCTG to give his/her stored urine samples for use in future research to outside researchers
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C44280 (NCI Thesaurus Property)
C0205101 (UMLS 2011AA Property)
C19157 (NCI Thesaurus Property)
C0370003 (UMLS 2011AA Property)
C25936 (NCI Thesaurus Property)
C0035173 (UMLS 2011AA Property)
C25460 (NCI Thesaurus Property)
C1511481 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Code List
Patient has given permission for NCCTG to give his/her stored urine samples for use in future research to outside researchers
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Patient has given permission to store and use his/her tissue samples for use in future research to learn about, prevent, or treat cancer
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C15319 (NCI Thesaurus Property)
C9305 (NCI Thesaurus Property)
C0006826 (UMLS 2011AA Property)
C19157 (NCI Thesaurus Property)
C0370003 (UMLS 2011AA Property)
C25460 (NCI Thesaurus Property)
C1511481 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Code List
Patient has given permission to store and use his/her tissue samples for use in future research to learn about, prevent, or treat cancer
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Patient has given permission to store and use his/her tissue samples for use in future research to learn about, prevent, or treat other health problems (for example: diabetes, Alzheimer's disease, or heart disease.)
text
C12801 (NCI Thesaurus ObjectClass)
C0040300 (UMLS 2011AA ObjectClass)
C12434 (NCI Thesaurus ObjectClass)
C0229664 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C15319 (NCI Thesaurus Property)
C2991 (NCI Thesaurus Property)
C0012634 (UMLS 2011AA Property)
C25460 (NCI Thesaurus Property)
C1511481 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
Code List
Patient has given permission to store and use his/her tissue samples for use in future research to learn about, prevent, or treat other health problems (for example: diabetes, Alzheimer's disease, or heart disease.)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Patient has given permission for NCCTG to give his/her stored tissue samples for use in future research to outside researchers
text
C12801 (NCI Thesaurus ObjectClass)
C0040300 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
C15319 (NCI Thesaurus Property)
C25648 (NCI Thesaurus Property)
C0439849 (UMLS 2011AA Property)
C9305 (NCI Thesaurus Property)
C0006826 (UMLS 2011AA Property)
C25460 (NCI Thesaurus Property)
C1511481 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
Code List
Patient has given permission for NCCTG to give his/her stored tissue samples for use in future research to outside researchers
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

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