ID

2681

Beskrivning

N1085 Eligibility Checklist Everolimus, Rituximab, and Combination Chemotherapy in Treating Patients With Newly Diagnosed Untreated Diffuse Large B-Cell Lymphoma Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=9EAFF494-0322-469D-E040-BB89AD43599E

Länk

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=9EAFF494-0322-469D-E040-BB89AD43599E

Nyckelord

Versioner (3)
  1. 2012-09-19 2012-09-19 -
  2. 2015-08-04 2015-08-04 - Martin Dugas
  3. 2021-09-20 2021-09-20 -
Uppladdad den

19 september 2012

DOI

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Licens

Creative Commons BY-NC 3.0 Legacy
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Lymphoma NCT01334502 Eligibility - N1085 Eligibility Checklist - 3204476v1.0

Engelsk

No Instruction available.

1 Formulär  
  1. StudyEvent: N1085 Eligibility Checklist
    1. No Instruction available.
Required Characteristics
Beskrivning

Required Characteristics

Age >= 18 years
Beskrivning

PatientAgeInd-2

Datatyp

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
Beskrivning

PatientAgeValue

Datatyp

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
Untreated, histological diagnosis of CD20-positive diffuse large B cell lymphoma
Beskrivning

DiffuseLargeB-CellLymphomaClassificationInd-2

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C8851
UMLS 2011AA ObjectClass
C0079744
NCI Thesaurus Property
C25161
UMLS 2011AA Property
C0008902
Stage II, III, or IV (Ann Arbor Staging: see Appendix II)
Beskrivning

TumorHistologicallyConfirmedInd-2

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus Property
C25458
UMLS 2011AA Property
C0750484
ECOG performance status (PS) 0, 1, or 2
Beskrivning

EasternCooperativeOncologyGroupPerformanceStatusAssessmentInd-2

Datatyp

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
Beskrivning

PerformanceStatusAssessmentEasternCooperativeOncologyGroupScale

Datatyp

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
The following laboratory values obtained <= 14 days prior to registration
Beskrivning

PatientPriorRegistrationLaboratoryProcedureEligibilityDeterminationInd-2

Datatyp

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
C25171
UMLS 2011AA Property
C0013893
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Earliest laboratory test date (NOTE: These dates pertain to the following labs only)
Beskrivning

LaboratoryProcedureEvaluationPerformedFirstDate

Datatyp

date

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C25214
UMLS 2011AA Property
C0220825
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
C25509
UMLS 2011AA ValueDomain
C1279901
Latest laboratory test date (NOTE: These dates pertain to the following labs only)
Beskrivning

LaboratoryProcedureEvaluationPerformedMostRecentDate

Datatyp

date

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C25214
UMLS 2011AA Property
C0220825
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
C25577
UMLS 2011AA ValueDomain
C1513491
Absolute neutrophil count (ANC) >=1,500/mm^3
Beskrivning

LaboratoryProcedureNeutrophilResultInd-2

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C12533
UMLS 2011AA Property
C0027950
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
ANC
Beskrivning

LaboratoryProcedureAbsoluteNeutrophilCountResultUnspecifiedValue

Datatyp

double

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C63321
UMLS 2011AA Property
C0948762
NCI Thesaurus ValueDomain
C38046
UMLS 2011AA ValueDomain
C0205370
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
Peripheral platelet count (PLT) >=100,000/mm^3
Beskrivning

LaboratoryProcedurePost-OperativeElevatedPlateletResultInd-2

Datatyp

text

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C25493
UMLS 2011AA Property
C0205250
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C12520
UMLS 2011AA Property
C0005821
NCI Thesaurus Property
C25623
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Peripheral Platelet Count
Beskrivning

LaboratoryProcedurePlateletResultUnspecifiedValue

Datatyp

double

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C12520
UMLS 2011AA Property
C0005821
NCI Thesaurus ValueDomain
C38046
UMLS 2011AA ValueDomain
C0205370
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
Hemoglobin >9.0 g/dL
Beskrivning

HematologyHemoglobinAssessmentInd-2

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus ObjectClass
C16673
UMLS 2011AA ObjectClass
C0018943
Hgb
Beskrivning

LaboratoryProcedureHemoglobinResultUnspecifiedValue

Datatyp

double

Alias
NCI Thesaurus Property
C16676
UMLS 2011AA Property
C0019046
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
Total bilirubin <=1.5 x ULN, or if total bilirubin is >1.5 ULN, the direct bilirubin must be normal
Beskrivning

LaboratoryProcedureWithinClinicalStudyProtocolUpperLimitofNormalTotalBilirubinMeasurementInd-2

Datatyp

text

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C25320
UMLS 2011AA Property
C1507394
NCI Thesaurus Property
C38037
UMLS 2011AA Property
C0201913
NCI Thesaurus Property
C25282
UMLS 2011AA Property
C0332285
NCI Thesaurus Property
C25706
UMLS 2011AA Property
C1519815
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Is total bilirubin >1.5 x ULN (this question may be answered yes or no)
Beskrivning

LaboratoryProcedureTotalBilirubinResultInd-2

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C38037
UMLS 2011AA Property
C0201913
Direct Bilirubin (If yes,)
Beskrivning

LaboratoryProcedureDirectBilirubinMeasurementResultUnspecifiedValue

Datatyp

double

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C64481
UMLS 2011AA Property
C0201916
NCI Thesaurus ValueDomain
C38046
UMLS 2011AA ValueDomain
C0205370
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
Direct Bilirubin ULN
Beskrivning

LaboratoryProcedureDirectBilirubinMeasurementResultUpperLimitNormalValue

Datatyp

double

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C64481
UMLS 2011AA Property
C0201916
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain
C25706
UMLS 2011AA ValueDomain
C1519815
Total Bilirubin (If no, <=1.5 x ULN)
Beskrivning

LaboratoryProcedureTotalBilirubinResultUnspecifiedValue

Datatyp

double

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C38037
UMLS 2011AA Property
C0201913
NCI Thesaurus ValueDomain
C38046
UMLS 2011AA ValueDomain
C0205370
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
Total Bilirubin ULN
Beskrivning

LaboratoryProcedureTotalBilirubinResultUpperLimitNormalValue

Datatyp

double

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C38037
UMLS 2011AA Property
C0201913
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain
C25706
UMLS 2011AA ValueDomain
C1519815
Alkaline phosphatase <=3 x ULN, unless evidence of direct liver involvement by lymphoma, then <=5 x ULN
Beskrivning

LaboratoryProcedureAlkalinePhosphataseEligibilityDeterminationInd-2

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C25171
UMLS 2011AA Property
C0013893
NCI Thesaurus Property
C16276
UMLS 2011AA Property
C0002059
Is there liver involvement (This question can be answered yes or no)
Beskrivning

LiverInvolvedInd-3

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C12392
UMLS 2011AA ObjectClass
C0023884
NCI Thesaurus Property
C25547
Is there liver involvement (This question can be answered yes or no)
Beskrivning

LiverInvolvedInd-3

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C12392
UMLS 2011AA ObjectClass
C0023884
NCI Thesaurus Property
C25547
Alkaline Phosphatase (If yes, <=5 x ULN If no, <=3 x ULN)
Beskrivning

LaboratoryProcedureAlkalinePhosphataseResultValue

Datatyp

double

Alias
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus Property
C16276
UMLS 2011AA Property
C0002059
Alkaline Phosphatase ULN
Beskrivning

LaboratoryProcedureAlkalinePhosphataseResultUpperLimitNormalValue

Datatyp

double

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C16276
UMLS 2011AA Property
C0002059
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain
C25706
UMLS 2011AA ValueDomain
C1519815
SGOT (AST) <=3 x ULN, unless evidence of direct liver involvement by lymphoma, then <=5 x ULN
Beskrivning

SerumAspartateAminotransferaseMeasurementHepaticWithinProtocolUpperLimitofNormalLabInd-2

Datatyp

text

Alias
NCI Thesaurus ObjectClass
C13308
UMLS 2011AA ObjectClass
C0205054
NCI Thesaurus ObjectClass
C61018
UMLS 2011AA ObjectClass
C1883009
NCI Thesaurus Property
C25320
UMLS 2011AA Property
C1507394
NCI Thesaurus Property
C37984
UMLS 2011AA Property
C0022877
NCI Thesaurus Property
C25282
UMLS 2011AA Property
C0332285
NCI Thesaurus Property
C25706
UMLS 2011AA Property
C1519815
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
SGOT (AST) (If Yes, <=5 x ULN If No, <=3 x ULN)
Beskrivning

LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseResultUnspecifiedValue

Datatyp

double

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C25202
UMLS 2011AA Property
C0242192
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus ValueDomain
C38046
UMLS 2011AA ValueDomain
C0205370
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
SGOT (AST) ULN
Beskrivning

LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseResultUnspecifiedUpperLimitofNormalValue

Datatyp

double

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C25202
UMLS 2011AA Property
C0242192
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain
C25706
UMLS 2011AA ValueDomain
C1519815
Creatinine <= ULN (mg/dL)
Beskrivning

LaboratoryProcedureCreatinineResultInd-2

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C399
UMLS 2011AA Property
C0010294
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
Creatinine
Beskrivning

LaboratoryProcedureCreatinineResultUnspecifiedValue

Datatyp

double

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C399
UMLS 2011AA Property
C0010294
NCI Thesaurus ValueDomain
C38046
UMLS 2011AA ValueDomain
C0205370
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
Creatinine ULN
Beskrivning

LaboratoryProcedureCreatinineResultUpperLimitNormalValue

Datatyp

double

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C399
UMLS 2011AA Property
C0010294
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain
C25706
UMLS 2011AA ValueDomain
C1519815
Negative serum or urine pregnancy test done <=14 days prior to registration, for women of childbearing potential only. If not a woman of childbearing potential or male (check NA)
Beskrivning

PatientNegativePregnancyTestIndicator

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25247
UMLS 2011AA Property
C0205160
NCI Metathesaurus Property
C0032976
Negative pregnancy test date (If a woman of childbearing potential)
Beskrivning

PatientNegativePregnancyTestDate

Datatyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25247
UMLS 2011AA Property
C0205160
NCI Metathesaurus Property
C0032976
Provide informed written consent
Beskrivning

PatientConsentAbilityInd-2

Datatyp

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
Willingness to return to NCCTG enrolling institution for follow-up
Beskrivning

PatientTherapeuticProcedureFollow-upEligibilityDeterminationInd-2

Datatyp

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C16033
UMLS 2011AA Property
C1522577
NCI Thesaurus Property
C49236
UMLS 2011AA Property
C0087111
NCI Thesaurus Property
C25171
UMLS 2011AA Property
C0013893
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Willing to provide mandatory blood samples for correlative research purposes (see Sections 6.241, 14.0)
Beskrivning

PersonSpecimenUseConsentEligibilityDeterminationIndicator

Datatyp

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
Willingness to abstain from eating grapefruit or drinking grapefruit juice for the duration of the study
Beskrivning

PatientGrapefruitAvoidanceClinicalTrialEligibilityCriteriaInd-2

Datatyp

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C16112
UMLS 2011AA Property
C1516637
NCI Thesaurus Property
C71974
UMLS 2011AA Property
C0995150
NCI Thesaurus Property
C54264
UMLS 2011AA Property
C0870186
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Willingness to take everolimus orally, once daily at the same time every day either consistently with food or consistently without food
Beskrivning

PatientEverolimusClinicalTrialEligibilityCriteriaInd-2

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C16112
UMLS 2011AA Property
C1516637
NCI Thesaurus Property
C48387
UMLS 2011AA Property
C0541315
Measurable or assessable disease defined as at least one of the following: A lymph node or tumor mass that is >=2.0 cm in at least one dimension by CT portion of PET/CT, CT or MRI. Diffuse infiltration of an organ such as the stomach, bone marrow, peripheral blood, liver, lungs or bowel by lymphoma without a discrete mass would constitute assessable, but not measurable, disease
Beskrivning

PersonMalignantNeoplasmMeasurableDiseasePresentClinicalTrialEligibilityCriteriaIndicator

Datatyp

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus Property
C9305
UMLS 2011AA Property
C0006826
NCI Thesaurus Property
C8507
UMLS 2011AA Property
C1513041
NCI Thesaurus Property
C16112
UMLS 2011AA Property
C1516637
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
If diabetic and taking insulin or oral anti-diabetic therapy, must have HbA1c <=8%, or a fasting serum glucose <=110% ULN (Note: The combination of everolimus with five days of concurrent prednisone at 100 mg/m^2 may cause significant hyperglycemia)
Beskrivning

PersonDiabetesMellitusTherapeuticProcedurePersonalMedicalHistoryInd-2

Datatyp

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C2985
UMLS 2011AA Property
C0011849
NCI Thesaurus Property
C49236
UMLS 2011AA Property
C0087111
NCI Thesaurus Property
C18772
UMLS 2011AA Property
C0262926
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
If HIV positive, CD4 count must be >=400
Beskrivning

LaboratoryProcedureCD4-PositiveT-LymphocyteOutcomeIndicator

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C12537
UMLS 2011AA Property
C0039215
Exclusion Criteria - All Responses In Section Below Must Be "no."
Beskrivning

Exclusion Criteria - All Responses In Section Below Must Be "no."

Because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown, any of the following are excluded: Pregnant women Nursing women Men or women of childbearing potential who are unwilling to employ adequate contraception throughout the study and for 8 weeks after the last dose of study drug, by both sexes (Note: Women of childbearing potential must have a negative pregnancy test <=14 days prior to registration)
Beskrivning

PatientContraceptionEligibilityDeterminationInd-2

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C37932
UMLS 2011AA Property
C0700589
NCI Thesaurus Property
C25171
UMLS 2011AA Property
C0013893
Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
Beskrivning

PatientConcurrentSystemicDiseaseorDisorderExclusionCriteriaInd-2

Datatyp

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
Immunocompromised patients (other than that related to the use of corticosteroids) including patients known to be HIV positive with a CD4 count of <400
Beskrivning

PatientImmunocompromisedExclusionCriteriaind-2

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25370
UMLS 2011AA Property
C0680251
NCI Thesaurus Property
C14139
UMLS 2011AA Property
C0085393
Uncontrolled intercurrent illness including, but not limited to: ongoing or active infection symptomatic congestive heart failure unstable angina pectoris cardiac arrhythmia severely impaired lung function uncontrolled diabetes as defined by fasting serum glucose >1.5 x ULN (Note: Optimal glycemic control should be achieved before starting trial therapy.) psychiatric illness/social situations that would limit compliance with study requirements liver disease such as cirrhosis or severe hepatic impairment chronic active hepatitis chronic persistent hepatitis or history of hepatitis B or C
Beskrivning

PatientUncontrolledConcurrentDiseaseorDisorderExclusionCriteriaInd-2

Datatyp

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C2991
UMLS 2011AA Property
C0012634
NCI Thesaurus Property
C25456
UMLS 2011AA Property
C0205420
NCI Thesaurus Property
C48932
UMLS 2011AA Property
C0205318
NCI Thesaurus Property
C25370
UMLS 2011AA Property
C0680251
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
Beskrivning

PatientInvestigationalClinicalTrialCurrentParticipationExclusionCriteriaInd-2

Datatyp

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
Active other malignancy, excepting non-melanotic skin cancer or carcinoma-in-situ of the cervix. If there is a history of prior malignancy, they must not be receiving other specific treatment (other than hormonal therapy) for their cancer
Beskrivning

PatientNeoplasmPersonalMedicalHistoryInd-2

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C3262
UMLS 2011AA Property
C0027651
NCI Thesaurus Property
C18772
UMLS 2011AA Property
C0262926
CNS Lymphoma or cerebrospinal fluid involvement with malignant lymphoma cells
Beskrivning

LymphomaCentralNervousSystemCerebrospinalFluidInvolvementInd-2

Datatyp

text

Alias
NCI Thesaurus ObjectClass
C3208
UMLS 2011AA ObjectClass
C0024299
NCI Thesaurus Property
C12438
UMLS 2011AA Property
C0927232
NCI Thesaurus Property
C12692
UMLS 2011AA Property
C0007806
NCI Thesaurus Property
C25548
UMLS 2011AA Property
C1314939
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Planned immunization with attenuated live vaccines <=7 days prior to registration or during study period (Note: Close contact with those who have received attenuated live vaccines should be avoided during treatment with everolimus. Examples of live vaccines include intranasal influenza, measles, mumps, rubella, oral polio, BCG, yellow fever, varicella and TY21a typhoid vaccines)
Beskrivning

AttenuatedLiveVirusVaccineImmunizationPlanInd-2

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C25619
UMLS 2011AA Property
C1301732
NCI Thesaurus ObjectClass
C1920
UMLS 2011AA ObjectClass
C1516086
NCI Thesaurus ObjectClass
C15258
UMLS 2011AA ObjectClass
C0020971
Positive hepatitis B antigen (HBsAg) or hepatitis C serology (HCV) tests (Note: Hepatitis B surface antigen Hbs Ag and antibody to Hepatitis B core anti-HBc; Hepatitis C antibody. All patients must be screened prior to registration. Those patients who have evidence of chronic or acute infection with either hepatitis B or C may not be treated on this protocol)
Beskrivning

HepaticInfectionPersonalMedicalHistoryInd-3

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C13308
UMLS 2011AA ObjectClass
C0205054
NCI Metathesaurus ObjectClass
C0021311
NCI Thesaurus Property
C18772
UMLS 2011AA Property
C0262926
Currently on enzyme inducing anti-convulsants or other strong inducers (efavirenz, nevirapine, barbiturates, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, pioglitazone) or strong inhibitors of CYP3A4 (indinavir, nelfinavir, ritonavir, clarithromycin, itraconazole, voriconazole, ketoconazole, nefazodone, saquinavir, telithromycin). (See http://medicine.iupui.edu/clinpharm/ddis/table.asp for an up-to-date list of strong inducers and inhibitors of CYP3A4.)
Beskrivning

AnticonvulsantMedicationReceivedInd-2

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C459
UMLS 2011AA ObjectClass
C0013227
NCI Thesaurus Property
C25639
UMLS 2011AA Property
C1514756
Pre-registration Check
Beskrivning

Pre-registration Check

A mandatory translational research component is part of this study, patients will automatically be registered to the translational research component of this study at the time of registration. (see Sections 3.19a, 14.0, 17.11, 17.2)
Beskrivning

PatientRegisteredInd-2

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25644
Consent form signed and dated
Beskrivning

InformedConsentFormSignedInd-2

Datatyp

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
Beskrivning

InformedConsentFormSignedDate

Datatyp

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 (U.S.A. institutions only If not a USA institution check NA)
Beskrivning

PatientHealthRecordIndicator

Datatyp

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 (If a USA institution)
Beskrivning

HealthInsurancePortabilityandAccountabilityActTissueDonorAuthorizationDate

Datatyp

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
Treatment cannot begin prior to registration and must begin <=14 days after registration
Beskrivning

ClinicalTrialTherapeuticProcedurePostRegistrationChecklistInd-2

Datatyp

text

Alias
NCI Thesaurus ObjectClass
C15207
NCI Thesaurus Property
C25646
UMLS 2011AA Property
C1514821
NCI Thesaurus Property
C38008
UMLS 2011AA Property
C0687676
NCI Thesaurus Property
C49236
UMLS 2011AA Property
C0087111
NCI Thesaurus Property
C49073
UMLS 2011AA Property
C1707357
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Pretreatment tests/procedures must be completed <= 14 days prior to registration (see Section 4.0)
Beskrivning

PatientPriorRegistrationLaboratoryProcedureVerificationInd-2

Datatyp

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 pretreatment test/procedure date (NOTE: The earliest pretreatment test date must be less than or equal to the earliest laboratory test date and the latest pretreatment test date must be greater than or equal to the latest laboratory test date)
Beskrivning

PatientPriorRegistrationLaboratoryProcedureEligibilityDeterminationBeginDate

Datatyp

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 pretreatment test/procedure date
Beskrivning

PatientPriorRegistrationLaboratoryProcedureEligibilityDeterminationEndDate

Datatyp

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
Beskrivning

ClinicalTrialBaselineDiseaseDocumentedChecklistInd-2

Datatyp

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
Tumor measurement/Evaluation of indicator lesion must be completed <=28 days prior to registration (Exceptions to the above dates)
Beskrivning

PatientPriorRegistrationLaboratoryProcedureMalignantNeoplasmEligibilityDeterminationInd-2

Datatyp

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25646
UMLS 2011AA Property
C1514821
NCI Thesaurus Property
C9305
UMLS 2011AA Property
C0006826
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
C38147
UMLS 2011AA ValueDomain
C1512698
Exception test date
Beskrivning

PatientPriorRegistrationLaboratoryProcedureMalignantNeoplasmEligibilityDeterminationDate

Datatyp

date

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25646
UMLS 2011AA Property
C1514821
NCI Thesaurus Property
C9305
UMLS 2011AA Property
C0006826
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
Bone marrow aspirate and biopsy must be completed <=42 days prior to registration (Exceptions to the above dates)
Beskrivning

PatientPriorRegistrationLaboratoryProcedureBoneMarrowEligibilityDeterminationInd-2

Datatyp

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25646
UMLS 2011AA Property
C1514821
NCI Thesaurus Property
C12431
UMLS 2011AA Property
C0005953
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
C38147
UMLS 2011AA ValueDomain
C1512698
Exception test date
Beskrivning

PatientPriorRegistrationLaboratoryProcedureBoneMarrowEligibilityDeterminationDate

Datatyp

date

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25646
UMLS 2011AA Property
C1514821
NCI Thesaurus Property
C12431
UMLS 2011AA Property
C0005953
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
Treatment on this protocol must commence at an NCCTG institution under the supervision of an NCCTG member physician
Beskrivning

ManagementNorthCentralCancerTreatmentGroupTherapyInd-2

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C25581
UMLS 2011AA ObjectClass
C1518419
NCI Thesaurus Property
C15368
NCI Thesaurus ObjectClass
C61372
UMLS 2011AA ObjectClass
C1273870
Blood draw kit is available on site
Beskrivning

ClinicalTrialBloodSpecimenCollectionAvailabilityChecklistInd-2

Datatyp

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
Ran
Beskrivning

Ran

Patient has given permission to give his/her blood sample for research testing (An optional correlative research component is part of this study, there will be an option to select if the patient is to be registered onto this component Section 17.11, 17.2.)
Beskrivning

PatientBloodSpecimenConsentInd-2

Datatyp

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C12434
UMLS 2011AA Property
C0229664
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 give his/her tissue sample for research testing (An optional correlative research component is part of this study, there will be an option to select if the patient is to be registered onto this component Section 17.11, 17.2.)
Beskrivning

PatientCorrelativeStudyTissueSpecimenConsentInd-2

Datatyp

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C12801
UMLS 2011AA Property
C0040300
NCI Thesaurus Property
C19157
UMLS 2011AA Property
C0370003
NCI Thesaurus Property
C25460
UMLS 2011AA Property
C1511481
NCI Thesaurus Property
C16100
UMLS 2011AA Property
C1511524
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Patient has given permission to store and use his/her sample(s) for use in future research to learn about, prevent, or treat cancer (At the time of registration/randomization, the following will also be recorded)
Beskrivning

PersonSpecimenMalignantNeoplasmFutureClinicalorResearchActivityConsentInd-2

Datatyp

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C67527
UMLS 2011AA Property
C0016884
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 Property
C16203
UMLS 2011AA Property
C1516654
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Patient has given permission to store and use his/her sample(s) for use in future research to learn about, prevent, or treat other health problems (for example: diabetes, Alzheimer's disease, or heart disease)
Beskrivning

BloodTissueSpecimenOtherDiseasesandDisordersResearchConsentInd-3

Datatyp

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 NCCTG permission to give sample(s) to outside researchers
Beskrivning

PersonSpecimenExternalInvestigatorConsentInd-2

Datatyp

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 agreed to be enrolled on N0392 (NOTE: N0392 must be open at site and offered to patient. At time of registration, willingness to participate will be recorded.)
Beskrivning

PatientNorthCentralCancerTreatmentGroupEnrollmentInd-2

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25581
UMLS 2011AA Property
C1518419
NCI Thesaurus Property
C37948
UMLS 2011AA Property
C1516879
Grouping Factor
Beskrivning

Grouping Factor

Cohort
Beskrivning

PhaseGroupingFactorType

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C25257
UMLS 2011AA ObjectClass
C0205390
NCI Thesaurus Property
C61039
UMLS 2011AA Property
C1881010
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1 Formulär
  1. StudyEvent: N1085 Eligibility Checklist
    1. No Instruction available.
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
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)
CL.1
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
Untreated, histological diagnosis of CD20-positive diffuse large B cell lymphoma
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C8851 (NCI Thesaurus ObjectClass)
C0079744 (UMLS 2011AA ObjectClass)
C25161 (NCI Thesaurus Property)
C0008902 (UMLS 2011AA Property)
CL.2
Code List
Untreated, histological diagnosis of CD20-positive diffuse large B cell lymphoma
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Stage II, III, or IV (Ann Arbor Staging: see Appendix II)
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25458 (NCI Thesaurus Property)
C0750484 (UMLS 2011AA Property)
CL.3
Code List
Stage II, III, or IV (Ann Arbor Staging: see Appendix II)
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)
CL.4
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)
CL.5
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
The following laboratory values obtained <= 14 days prior to registration
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)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.6
Code List
The following laboratory values obtained <= 14 days prior to registration
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
LaboratoryProcedureEvaluationPerformedFirstDate
Item
Earliest laboratory test date (NOTE: These dates pertain to the following labs only)
date
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25214 (NCI Thesaurus Property)
C0220825 (UMLS 2011AA Property)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25509 (NCI Thesaurus ValueDomain)
C1279901 (UMLS 2011AA ValueDomain)
LaboratoryProcedureEvaluationPerformedMostRecentDate
Item
Latest laboratory test date (NOTE: These dates pertain to the following labs only)
date
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25214 (NCI Thesaurus Property)
C0220825 (UMLS 2011AA Property)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25577 (NCI Thesaurus ValueDomain)
C1513491 (UMLS 2011AA ValueDomain)
Item
Absolute neutrophil count (ANC) >=1,500/mm^3
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C12533 (NCI Thesaurus Property)
C0027950 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
CL.7
Code List
Absolute neutrophil count (ANC) >=1,500/mm^3
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
LaboratoryProcedureAbsoluteNeutrophilCountResultUnspecifiedValue
Item
ANC
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C63321 (NCI Thesaurus Property)
C0948762 (UMLS 2011AA Property)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
Item
Peripheral platelet count (PLT) >=100,000/mm^3
text
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25493 (NCI Thesaurus Property)
C0205250 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C12520 (NCI Thesaurus Property)
C0005821 (UMLS 2011AA Property)
C25623 (NCI Thesaurus Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.8
Code List
Peripheral platelet count (PLT) >=100,000/mm^3
CL Item
Yes (yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
LaboratoryProcedurePlateletResultUnspecifiedValue
Item
Peripheral Platelet Count
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C12520 (NCI Thesaurus Property)
C0005821 (UMLS 2011AA Property)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
Item
Hemoglobin >9.0 g/dL
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C16673 (NCI Thesaurus ObjectClass)
C0018943 (UMLS 2011AA ObjectClass)
CL.9
Code List
Hemoglobin >9.0 g/dL
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
LaboratoryProcedureHemoglobinResultUnspecifiedValue
Item
Hgb
double
C16676 (NCI Thesaurus Property)
C0019046 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
Item
Total bilirubin <=1.5 x ULN, or if total bilirubin is >1.5 ULN, the direct bilirubin must be normal
text
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25320 (NCI Thesaurus Property)
C1507394 (UMLS 2011AA Property)
C38037 (NCI Thesaurus Property)
C0201913 (UMLS 2011AA Property)
C25282 (NCI Thesaurus Property)
C0332285 (UMLS 2011AA Property)
C25706 (NCI Thesaurus Property)
C1519815 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.10
Code List
Total bilirubin <=1.5 x ULN, or if total bilirubin is >1.5 ULN, the direct bilirubin must be normal
CL Item
Yes (yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Is total bilirubin >1.5 x ULN (this question may be answered yes or no)
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C38037 (NCI Thesaurus Property)
C0201913 (UMLS 2011AA Property)
CL.11
Code List
Is total bilirubin >1.5 x ULN (this question may be answered yes or no)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
LaboratoryProcedureDirectBilirubinMeasurementResultUnspecifiedValue
Item
Direct Bilirubin (If yes,)
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C64481 (NCI Thesaurus Property)
C0201916 (UMLS 2011AA Property)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
LaboratoryProcedureDirectBilirubinMeasurementResultUpperLimitNormalValue
Item
Direct Bilirubin ULN
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C64481 (NCI Thesaurus Property)
C0201916 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain)
C1519815 (UMLS 2011AA ValueDomain)
LaboratoryProcedureTotalBilirubinResultUnspecifiedValue
Item
Total Bilirubin (If no, <=1.5 x ULN)
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C38037 (NCI Thesaurus Property)
C0201913 (UMLS 2011AA Property)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
LaboratoryProcedureTotalBilirubinResultUpperLimitNormalValue
Item
Total Bilirubin ULN
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C38037 (NCI Thesaurus Property)
C0201913 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain)
C1519815 (UMLS 2011AA ValueDomain)
Item
Alkaline phosphatase <=3 x ULN, unless evidence of direct liver involvement by lymphoma, then <=5 x ULN
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
C16276 (NCI Thesaurus Property)
C0002059 (UMLS 2011AA Property)
CL.12
Code List
Alkaline phosphatase <=3 x ULN, unless evidence of direct liver involvement by lymphoma, then <=5 x ULN
CL Item
Yes (yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Is there liver involvement (This question can be answered yes or no)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C12392 (NCI Thesaurus ObjectClass)
C0023884 (UMLS 2011AA ObjectClass)
C25547 (NCI Thesaurus Property)
CL.15
Code List
Is there liver involvement (This question can be answered yes or no)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Is there liver involvement (This question can be answered yes or no)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C12392 (NCI Thesaurus ObjectClass)
C0023884 (UMLS 2011AA ObjectClass)
C25547 (NCI Thesaurus Property)
CL.15
Code List
Is there liver involvement (This question can be answered yes or no)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
LaboratoryProcedureAlkalinePhosphataseResultValue
Item
Alkaline Phosphatase (If yes, <=5 x ULN If no, <=3 x ULN)
double
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C16276 (NCI Thesaurus Property)
C0002059 (UMLS 2011AA Property)
LaboratoryProcedureAlkalinePhosphataseResultUpperLimitNormalValue
Item
Alkaline Phosphatase ULN
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C16276 (NCI Thesaurus Property)
C0002059 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain)
C1519815 (UMLS 2011AA ValueDomain)
Item
SGOT (AST) <=3 x ULN, unless evidence of direct liver involvement by lymphoma, then <=5 x ULN
text
C13308 (NCI Thesaurus ObjectClass)
C0205054 (UMLS 2011AA ObjectClass)
C61018 (NCI Thesaurus ObjectClass)
C1883009 (UMLS 2011AA ObjectClass)
C25320 (NCI Thesaurus Property)
C1507394 (UMLS 2011AA Property)
C37984 (NCI Thesaurus Property)
C0022877 (UMLS 2011AA Property)
C25282 (NCI Thesaurus Property)
C0332285 (UMLS 2011AA Property)
C25706 (NCI Thesaurus Property)
C1519815 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.14
Code List
SGOT (AST) <=3 x ULN, unless evidence of direct liver involvement by lymphoma, then <=5 x ULN
CL Item
Yes (yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseResultUnspecifiedValue
Item
SGOT (AST) (If Yes, <=5 x ULN If No, <=3 x ULN)
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25202 (NCI Thesaurus Property)
C0242192 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseResultUnspecifiedUpperLimitofNormalValue
Item
SGOT (AST) ULN
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25202 (NCI Thesaurus Property)
C0242192 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain)
C1519815 (UMLS 2011AA ValueDomain)
Item
Creatinine <= ULN (mg/dL)
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C399 (NCI Thesaurus Property)
C0010294 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
CL.16
Code List
Creatinine <= ULN (mg/dL)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
LaboratoryProcedureCreatinineResultUnspecifiedValue
Item
Creatinine
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C399 (NCI Thesaurus Property)
C0010294 (UMLS 2011AA Property)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
LaboratoryProcedureCreatinineResultUpperLimitNormalValue
Item
Creatinine ULN
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C399 (NCI Thesaurus Property)
C0010294 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain)
C1519815 (UMLS 2011AA ValueDomain)
Item
Negative serum or urine pregnancy test done <=14 days prior to registration, for women of childbearing potential only. If not a woman of childbearing potential or male (check NA)
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25247 (NCI Thesaurus Property)
C0205160 (UMLS 2011AA Property)
C0032976 (NCI Metathesaurus Property)
CL.17
Code List
Negative serum or urine pregnancy test done <=14 days prior to registration, for women of childbearing potential only. If not a woman of childbearing potential or male (check NA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
N/a (N/A)
PatientNegativePregnancyTestDate
Item
Negative pregnancy test date (If a woman of childbearing potential)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25247 (NCI Thesaurus Property)
C0205160 (UMLS 2011AA Property)
C0032976 (NCI Metathesaurus Property)
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)
CL.18
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
Willingness to return to NCCTG enrolling institution for follow-up
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C16033 (NCI Thesaurus Property)
C1522577 (UMLS 2011AA Property)
C49236 (NCI Thesaurus Property)
C0087111 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.19
Code List
Willingness to return to NCCTG enrolling institution for follow-up
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Willing to provide mandatory blood samples for correlative research purposes (see Sections 6.241, 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)
CL.20
Code List
Willing to provide mandatory blood samples for correlative research purposes (see Sections 6.241, 14.0)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Willingness to abstain from eating grapefruit or drinking grapefruit juice for the duration of the study
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C16112 (NCI Thesaurus Property)
C1516637 (UMLS 2011AA Property)
C71974 (NCI Thesaurus Property)
C0995150 (UMLS 2011AA Property)
C54264 (NCI Thesaurus Property)
C0870186 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.21
Code List
Willingness to abstain from eating grapefruit or drinking grapefruit juice for the duration of the study
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Willingness to take everolimus orally, once daily at the same time every day either consistently with food or consistently without food
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C16112 (NCI Thesaurus Property)
C1516637 (UMLS 2011AA Property)
C48387 (NCI Thesaurus Property)
C0541315 (UMLS 2011AA Property)
CL.22
Code List
Willingness to take everolimus orally, once daily at the same time every day either consistently with food or consistently without food
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Measurable or assessable disease defined as at least one of the following: A lymph node or tumor mass that is >=2.0 cm in at least one dimension by CT portion of PET/CT, CT or MRI. Diffuse infiltration of an organ such as the stomach, bone marrow, peripheral blood, liver, lungs or bowel by lymphoma without a discrete mass would constitute assessable, but not measurable, disease
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C9305 (NCI Thesaurus Property)
C0006826 (UMLS 2011AA Property)
C8507 (NCI Thesaurus Property)
C1513041 (UMLS 2011AA Property)
C16112 (NCI Thesaurus Property)
C1516637 (UMLS 2011AA Property)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
CL.23
Code List
Measurable or assessable disease defined as at least one of the following: A lymph node or tumor mass that is >=2.0 cm in at least one dimension by CT portion of PET/CT, CT or MRI. Diffuse infiltration of an organ such as the stomach, bone marrow, peripheral blood, liver, lungs or bowel by lymphoma without a discrete mass would constitute assessable, but not measurable, disease
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
If diabetic and taking insulin or oral anti-diabetic therapy, must have HbA1c <=8%, or a fasting serum glucose <=110% ULN (Note: The combination of everolimus with five days of concurrent prednisone at 100 mg/m^2 may cause significant hyperglycemia)
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C2985 (NCI Thesaurus Property)
C0011849 (UMLS 2011AA Property)
C49236 (NCI Thesaurus Property)
C0087111 (UMLS 2011AA Property)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.24
Code List
If diabetic and taking insulin or oral anti-diabetic therapy, must have HbA1c <=8%, or a fasting serum glucose <=110% ULN (Note: The combination of everolimus with five days of concurrent prednisone at 100 mg/m^2 may cause significant hyperglycemia)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
If HIV positive, CD4 count must be >=400
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C12537 (NCI Thesaurus Property)
C0039215 (UMLS 2011AA Property)
CL.25
Code List
If HIV positive, CD4 count must be >=400
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item Group
Exclusion Criteria - All Responses In Section Below Must Be "no."
Item
Because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown, any of the following are excluded: Pregnant women Nursing women Men or women of childbearing potential who are unwilling to employ adequate contraception throughout the study and for 8 weeks after the last dose of study drug, by both sexes (Note: Women of childbearing potential must have a negative pregnancy test <=14 days prior to registration)
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C37932 (NCI Thesaurus Property)
C0700589 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
CL.26
Code List
Because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown, any of the following are excluded: Pregnant women Nursing women Men or women of childbearing potential who are unwilling to employ adequate contraception throughout the study and for 8 weeks after the last dose of study drug, by both sexes (Note: Women of childbearing potential must have a negative pregnancy test <=14 days prior to registration)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
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)
CL.27
Code List
Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Immunocompromised patients (other than that related to the use of corticosteroids) including patients known to be HIV positive with a CD4 count of <400
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25370 (NCI Thesaurus Property)
C0680251 (UMLS 2011AA Property)
C14139 (NCI Thesaurus Property)
C0085393 (UMLS 2011AA Property)
CL.28
Code List
Immunocompromised patients (other than that related to the use of corticosteroids) including patients known to be HIV positive with a CD4 count of <400
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Uncontrolled intercurrent illness including, but not limited to: ongoing or active infection symptomatic congestive heart failure unstable angina pectoris cardiac arrhythmia severely impaired lung function uncontrolled diabetes as defined by fasting serum glucose >1.5 x ULN (Note: Optimal glycemic control should be achieved before starting trial therapy.) psychiatric illness/social situations that would limit compliance with study requirements liver disease such as cirrhosis or severe hepatic impairment chronic active hepatitis chronic persistent hepatitis or history of hepatitis B or C
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C2991 (NCI Thesaurus Property)
C0012634 (UMLS 2011AA Property)
C25456 (NCI Thesaurus Property)
C0205420 (UMLS 2011AA Property)
C48932 (NCI Thesaurus Property)
C0205318 (UMLS 2011AA Property)
C25370 (NCI Thesaurus Property)
C0680251 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.29
Code List
Uncontrolled intercurrent illness including, but not limited to: ongoing or active infection symptomatic congestive heart failure unstable angina pectoris cardiac arrhythmia severely impaired lung function uncontrolled diabetes as defined by fasting serum glucose >1.5 x ULN (Note: Optimal glycemic control should be achieved before starting trial therapy.) psychiatric illness/social situations that would limit compliance with study requirements liver disease such as cirrhosis or severe hepatic impairment chronic active hepatitis chronic persistent hepatitis or history of hepatitis B or C
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
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)
CL.30
Code List
Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Active other malignancy, excepting non-melanotic skin cancer or carcinoma-in-situ of the cervix. If there is a history of prior malignancy, they must not be receiving other specific treatment (other than hormonal therapy) for their cancer
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C3262 (NCI Thesaurus Property)
C0027651 (UMLS 2011AA Property)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)
CL.31
Code List
Active other malignancy, excepting non-melanotic skin cancer or carcinoma-in-situ of the cervix. If there is a history of prior malignancy, they must not be receiving other specific treatment (other than hormonal therapy) for their cancer
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
CNS Lymphoma or cerebrospinal fluid involvement with malignant lymphoma cells
text
C3208 (NCI Thesaurus ObjectClass)
C0024299 (UMLS 2011AA ObjectClass)
C12438 (NCI Thesaurus Property)
C0927232 (UMLS 2011AA Property)
C12692 (NCI Thesaurus Property)
C0007806 (UMLS 2011AA Property)
C25548 (NCI Thesaurus Property)
C1314939 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.32
Code List
CNS Lymphoma or cerebrospinal fluid involvement with malignant lymphoma cells
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Planned immunization with attenuated live vaccines <=7 days prior to registration or during study period (Note: Close contact with those who have received attenuated live vaccines should be avoided during treatment with everolimus. Examples of live vaccines include intranasal influenza, measles, mumps, rubella, oral polio, BCG, yellow fever, varicella and TY21a typhoid vaccines)
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25619 (NCI Thesaurus Property)
C1301732 (UMLS 2011AA Property)
C1920 (NCI Thesaurus ObjectClass)
C1516086 (UMLS 2011AA ObjectClass)
C15258 (NCI Thesaurus ObjectClass)
C0020971 (UMLS 2011AA ObjectClass)
CL.33
Code List
Planned immunization with attenuated live vaccines <=7 days prior to registration or during study period (Note: Close contact with those who have received attenuated live vaccines should be avoided during treatment with everolimus. Examples of live vaccines include intranasal influenza, measles, mumps, rubella, oral polio, BCG, yellow fever, varicella and TY21a typhoid vaccines)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Positive hepatitis B antigen (HBsAg) or hepatitis C serology (HCV) tests (Note: Hepatitis B surface antigen Hbs Ag and antibody to Hepatitis B core anti-HBc; Hepatitis C antibody. All patients must be screened prior to registration. Those patients who have evidence of chronic or acute infection with either hepatitis B or C may not be treated on this protocol)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C13308 (NCI Thesaurus ObjectClass)
C0205054 (UMLS 2011AA ObjectClass)
C0021311 (NCI Metathesaurus ObjectClass)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)
CL.34
Code List
Positive hepatitis B antigen (HBsAg) or hepatitis C serology (HCV) tests (Note: Hepatitis B surface antigen Hbs Ag and antibody to Hepatitis B core anti-HBc; Hepatitis C antibody. All patients must be screened prior to registration. Those patients who have evidence of chronic or acute infection with either hepatitis B or C may not be treated on this protocol)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Currently on enzyme inducing anti-convulsants or other strong inducers (efavirenz, nevirapine, barbiturates, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, pioglitazone) or strong inhibitors of CYP3A4 (indinavir, nelfinavir, ritonavir, clarithromycin, itraconazole, voriconazole, ketoconazole, nefazodone, saquinavir, telithromycin). (See http://medicine.iupui.edu/clinpharm/ddis/table.asp for an up-to-date list of strong inducers and inhibitors of CYP3A4.)
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C459 (NCI Thesaurus ObjectClass)
C0013227 (UMLS 2011AA ObjectClass)
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
CL.35
Code List
Currently on enzyme inducing anti-convulsants or other strong inducers (efavirenz, nevirapine, barbiturates, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, pioglitazone) or strong inhibitors of CYP3A4 (indinavir, nelfinavir, ritonavir, clarithromycin, itraconazole, voriconazole, ketoconazole, nefazodone, saquinavir, telithromycin). (See http://medicine.iupui.edu/clinpharm/ddis/table.asp for an up-to-date list of strong inducers and inhibitors of CYP3A4.)
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
A mandatory translational research component is part of this study, patients will automatically be registered to the translational research component of this study at the time of registration. (see Sections 3.19a, 14.0, 17.11, 17.2)
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25644 (NCI Thesaurus Property)
CL.36
Code List
A mandatory translational research component is part of this study, patients will automatically be registered to the translational research component of this study at the time of registration. (see Sections 3.19a, 14.0, 17.11, 17.2)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
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)
CL.37
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
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 (U.S.A. institutions only 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.38
Code List
Authorization for use and disclosure of protected health information signed and dated (U.S.A. institutions only 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)
C1272460 (UMLS 2011AA)
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)
C1524004 (UMLS 2011AA Property)
Item
Treatment cannot begin prior to registration and must begin <=14 days after registration
text
C15207 (NCI Thesaurus ObjectClass)
C25646 (NCI Thesaurus Property)
C1514821 (UMLS 2011AA Property)
C38008 (NCI Thesaurus Property)
C0687676 (UMLS 2011AA Property)
C49236 (NCI Thesaurus Property)
C0087111 (UMLS 2011AA Property)
C49073 (NCI Thesaurus Property)
C1707357 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.39
Code List
Treatment cannot begin prior to registration and must begin <=14 days after registration
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Pretreatment tests/procedures must be completed <= 14 days prior to 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)
CL.40
Code List
Pretreatment tests/procedures must be completed <= 14 days prior to 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 pretreatment test/procedure date (NOTE: The earliest pretreatment test date must be less than or equal to the earliest laboratory test date and the latest pretreatment test date must be greater than or equal to the latest laboratory test date)
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 pretreatment test/procedure date
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)
CL.41
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
Tumor measurement/Evaluation of indicator lesion must be completed <=28 days prior to registration (Exceptions to the above dates)
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25646 (NCI Thesaurus Property)
C1514821 (UMLS 2011AA Property)
C9305 (NCI Thesaurus Property)
C0006826 (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)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.42
Code List
Tumor measurement/Evaluation of indicator lesion must be completed <=28 days prior to registration (Exceptions to the above dates)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
PatientPriorRegistrationLaboratoryProcedureMalignantNeoplasmEligibilityDeterminationDate
Item
Exception test date
date
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25646 (NCI Thesaurus Property)
C1514821 (UMLS 2011AA Property)
C9305 (NCI Thesaurus Property)
C0006826 (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
Bone marrow aspirate and biopsy must be completed <=42 days prior to registration (Exceptions to the above dates)
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25646 (NCI Thesaurus Property)
C1514821 (UMLS 2011AA Property)
C12431 (NCI Thesaurus Property)
C0005953 (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)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.43
Code List
Bone marrow aspirate and biopsy must be completed <=42 days prior to registration (Exceptions to the above dates)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
PatientPriorRegistrationLaboratoryProcedureBoneMarrowEligibilityDeterminationDate
Item
Exception test date
date
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25646 (NCI Thesaurus Property)
C1514821 (UMLS 2011AA Property)
C12431 (NCI Thesaurus Property)
C0005953 (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
Treatment on this protocol must commence at an NCCTG institution under the supervision of an NCCTG member physician
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25581 (NCI Thesaurus ObjectClass)
C1518419 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus Property)
C61372 (NCI Thesaurus ObjectClass)
C1273870 (UMLS 2011AA ObjectClass)
CL.44
Code List
Treatment on this protocol must commence at an NCCTG institution under the supervision of an NCCTG member physician
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Blood draw kit is 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)
CL.45
Code List
Blood draw kit is 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 has given permission to give his/her blood sample for research testing (An optional correlative research component is part of this study, there will be an option to select if the patient is to be registered onto this component Section 17.11, 17.2.)
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C12434 (NCI Thesaurus Property)
C0229664 (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)
CL.46
Code List
Patient has given permission to give his/her blood sample for research testing (An optional correlative research component is part of this study, there will be an option to select if the patient is to be registered onto this component Section 17.11, 17.2.)
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 give his/her tissue sample for research testing (An optional correlative research component is part of this study, there will be an option to select if the patient is to be registered onto this component Section 17.11, 17.2.)
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C12801 (NCI Thesaurus Property)
C0040300 (UMLS 2011AA Property)
C19157 (NCI Thesaurus Property)
C0370003 (UMLS 2011AA Property)
C25460 (NCI Thesaurus Property)
C1511481 (UMLS 2011AA Property)
C16100 (NCI Thesaurus Property)
C1511524 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.47
Code List
Patient has given permission to give his/her tissue sample for research testing (An optional correlative research component is part of this study, there will be an option to select if the patient is to be registered onto this component Section 17.11, 17.2.)
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 sample(s) for use in future research to learn about, prevent, or treat cancer (At the time of registration/randomization, the following will also be recorded)
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C67527 (NCI Thesaurus Property)
C0016884 (UMLS 2011AA 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)
C16203 (NCI Thesaurus Property)
C1516654 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.48
Code List
Patient has given permission to store and use his/her sample(s) for use in future research to learn about, prevent, or treat cancer (At the time of registration/randomization, the following will also be recorded)
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 sample(s) 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)
CL.49
Code List
Patient has given permission to store and use his/her sample(s) 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 NCCTG permission to give sample(s) 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)
CL.50
Code List
Patient has given NCCTG permission to give sample(s) 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 agreed to be enrolled on N0392 (NOTE: N0392 must be open at site and offered to patient. At time of registration, willingness to participate will be recorded.)
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25581 (NCI Thesaurus Property)
C1518419 (UMLS 2011AA Property)
C37948 (NCI Thesaurus Property)
C1516879 (UMLS 2011AA Property)
CL.51
Code List
Patient has agreed to be enrolled on N0392 (NOTE: N0392 must be open at site and offered to patient. At time of registration, willingness to participate will be recorded.)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item Group
Grouping Factor
Item
Cohort
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25257 (NCI Thesaurus ObjectClass)
C0205390 (UMLS 2011AA ObjectClass)
C61039 (NCI Thesaurus Property)
C1881010 (UMLS 2011AA Property)
CL.52
Code List
Cohort
CL Item
Phase I (Phase I)
CL Item
Feasibility (Feasibility)
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