ID

43238

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

20 september 2021

DOI

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Licens

Creative Commons BY-NC 3.0 Legacy
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Eligibility B-Cell Lymphoma N1085 NCT01334502

Engelsk

No Instruction available.

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

Required Characteristics

18 Years and older
Beskrivning

18 Years and older

Datatyp

boolean

Alias
NCI Thesaurus ValueDomain
C38147
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25150
UMLS CUI [1]
C0001779
Age
Beskrivning

Age

Datatyp

integer

Måttenheter
  • years
Alias
NCI Thesaurus ValueDomain
C25337
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25150
UMLS CUI [1]
C0001779
years
Untreated, histological diagnosis of CD20-positive diffuse large B cell lymphoma
Beskrivning

DiffuseLargeB-CellLymphomaClassificationInd-2

Datatyp

boolean

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

boolean

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

boolean

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

PerformanceStatusAssessmentEasternCooperativeOncologyGroupScale

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS 2011AA ValueDomain
C0349674
NCI Thesaurus Property
C25367
NCI Thesaurus ValueDomain-2
C25491
UMLS 2011AA ValueDomain-2
C1512162
NCI Thesaurus ObjectClass
C20641
UMLS 2011AA ObjectClass
C1518965
The following laboratory values obtained <= 14 days prior to registration
Beskrivning

PatientPriorRegistrationLaboratoryProcedureEligibilityDeterminationInd-2

Datatyp

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25646
UMLS 2011AA Property
C1514821
NCI Thesaurus Property-2
C25629
UMLS 2011AA Property-2
C0332152
NCI Thesaurus Property-3
C25294
UMLS 2011AA Property-3
C0022885
NCI Thesaurus Property-4
C25171
UMLS 2011AA Property-4
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-2
C38000
UMLS 2011AA Property-2
C0884358
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25509
UMLS 2011AA ValueDomain-2
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-2
C38000
UMLS 2011AA Property-2
C0884358
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25577
UMLS 2011AA ValueDomain-2
C1513491
Absolute neutrophil count (ANC) >=1500/mm3
Beskrivning

LaboratoryProcedureNeutrophilResultInd-2

Datatyp

boolean

Alias
NCI Thesaurus ValueDomain
C38147
NCI Thesaurus Property
C12533
NCI Thesaurus Property-2
C20200
NCI Thesaurus ObjectClass
C25294
UMLS CUI [1]
C0948762
ANC
Beskrivning

ANC

Datatyp

float

Måttenheter
  • 1000/ul
Alias
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus Property
C20200
NCI Thesaurus Property-2
C63321
NCI Thesaurus ValueDomain
C38046
NCI Thesaurus ValueDomain-2
C25712
UMLS CUI [1]
C0200633
1000/ul
Peripheral platelet count (PLT) >=100,000/mm^3
Beskrivning

LaboratoryProcedurePost-OperativeElevatedPlateletResultInd-2

Datatyp

boolean

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C25493
UMLS 2011AA Property
C0205250
NCI Thesaurus Property-2
C20200
UMLS 2011AA Property-2
C1274040
NCI Thesaurus Property-3
C12520
UMLS 2011AA Property-3
C0005821
NCI Thesaurus Property-4
C25623
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Peripheral Platelet Count
Beskrivning

Peripheral Platelet Count

Datatyp

float

Måttenheter
  • 1000/uL
Alias
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus Property
C20200
NCI Thesaurus Property-2
C12520
NCI Thesaurus ValueDomain
C38046
NCI Thesaurus ValueDomain-2
C25712
UMLS CUI [1]
C0005821
1000/uL
Hemoglobin >9.0 g/dL
Beskrivning

HematologyHemoglobinAssessmentInd-2

Datatyp

boolean

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
Hemoglobin
Beskrivning

Hemoglobin

Datatyp

float

Måttenheter
  • g/dL
Alias
NCI Thesaurus Property
C16676
NCI Thesaurus Property-2
C20200
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus ValueDomain
C25712
UMLS CUI [1]
C0019046
g/dL
Total bilirubin <=1.5 x ULN, or if total bilirubin is >1.5 ULN, the direct bilirubin must be normal
Beskrivning

LaboratoryProcedureWithinClinicalStudyProtocolUpperLimitofNormalTotalBilirubinMeasurementInd-2

Datatyp

boolean

Alias
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus Property
C25320
NCI Thesaurus Property-2
C38037
NCI Thesaurus Property-3
C25282
NCI Thesaurus Property-4
C25706
NCI Thesaurus ValueDomain
C38147
UMLS CUI [1,1]
C0201913
UMLS CUI [1,2]
C1519815
Is total bilirubin >1.5 x ULN (this question may be answered yes or no)
Beskrivning

LaboratoryProcedureTotalBilirubinResultInd-2

Datatyp

boolean

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-2
C38037
UMLS 2011AA Property-2
C0201913
Direct Bilirubin
Beskrivning

Direct Bilirubin

Datatyp

float

Måttenheter
  • mg/dL
Alias
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus Property
C20200
NCI Thesaurus Property-2
C64481
NCI Thesaurus ValueDomain
C38046
NCI Thesaurus ValueDomain-2
C25712
UMLS CUI [1]
C0201916
mg/dL
Direct Bilirubin ULN
Beskrivning

Direct Bilirubin ULN

Datatyp

float

Måttenheter
  • mg/dL
Alias
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus Property
C20200
NCI Thesaurus Property-2
C64481
NCI Thesaurus ValueDomain
C25712
NCI Thesaurus ValueDomain-2
C25706
UMLS CUI [1,1]
C0201916
UMLS CUI [1,2]
C1519815
mg/dL
Total Bilirubin
Beskrivning

Total Bilirubin

Datatyp

float

Måttenheter
  • mg/dL
Alias
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus Property
C20200
NCI Thesaurus Property-2
C38037
NCI Thesaurus ValueDomain
C38046
NCI Thesaurus ValueDomain-2
C25712
UMLS CUI [1]
C0201913
mg/dL
Total bilirubin ULN
Beskrivning

Total bilirubin ULN

Datatyp

float

Måttenheter
  • mg/dL
Alias
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus Property
C20200
NCI Thesaurus Property-2
C38037
NCI Thesaurus ValueDomain
C25712
NCI Thesaurus ValueDomain-2
C25706
UMLS CUI [1,1]
C0201913
UMLS CUI [1,2]
C1519815
mg/dL
Alkaline phosphatase <=3 x ULN, unless evidence of direct liver involvement by lymphoma, then <=5 x ULN
Beskrivning

LaboratoryProcedureAlkalinePhosphataseEligibilityDeterminationInd-2

Datatyp

boolean

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-2
C16276
UMLS 2011AA Property-2
C0002059
Is there liver involvement (This question can be answered yes or no)
Beskrivning

LiverInvolvedInd-3

Datatyp

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C12392
UMLS 2011AA ObjectClass
C0023884
NCI Thesaurus Property
C25547
Alkaline Phosphatase
Beskrivning

Alkaline Phosphatase

Datatyp

float

Måttenheter
  • U/L
Alias
NCI Thesaurus Property
C20200
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus ValueDomain
C25712
NCI Thesaurus Property-2
C16276
UMLS CUI [1]
C0201850
U/L
Alkaline Phosphatase ULN
Beskrivning

Alkaline Phosphatase ULN

Datatyp

float

Måttenheter
  • U/L
Alias
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus Property
C20200
NCI Thesaurus Property-2
C16276
NCI Thesaurus ValueDomain
C25712
NCI Thesaurus ValueDomain-2
C25706
UMLS CUI [1,1]
C0151420
UMLS CUI [1,2]
C1519815
U/L
SGOT (AST) <=3 x ULN, unless evidence of direct liver involvement by lymphoma, then <=5 x ULN
Beskrivning

SerumAspartateAminotransferaseMeasurementHepaticWithinProtocolUpperLimitofNormalLabInd-2

Datatyp

boolean

Alias
NCI Thesaurus ObjectClass
C13308
NCI Thesaurus ObjectClass-2
C61018
NCI Thesaurus Property
C25320
NCI Thesaurus Property-2
C37984
NCI Thesaurus Property-3
C25282
NCI Thesaurus Property-4
C25706
NCI Thesaurus ValueDomain
C38147
UMLS CUI [1,1]
C0201899
UMLS CUI [1,2]
C1519815
AST (SGOT)
Beskrivning

AST (SGOT)

Datatyp

float

Måttenheter
  • U/L
Alias
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus Property
C25202
NCI Thesaurus Property-2
C20200
NCI Thesaurus ValueDomain
C38046
NCI Thesaurus ValueDomain-2
C25712
UMLS CUI [1]
C0201899
U/L
AST (SGOT) ULN
Beskrivning

AST (SGOT) ULN

Datatyp

float

Måttenheter
  • U/L
Alias
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus Property
C25202
NCI Thesaurus Property-2
C20200
NCI Thesaurus ValueDomain
C25712
NCI Thesaurus ValueDomain-2
C25706
UMLS CUI [1,1]
C0242192
UMLS CUI [1,2]
C1519815
U/L
Creatinine <= ULN (mg/dL)
Beskrivning

LaboratoryProcedureCreatinineResultInd-2

Datatyp

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C399
UMLS 2011AA Property-2
C0010294
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
Serum creatinine
Beskrivning

Serum creatinine

Datatyp

float

Måttenheter
  • mg/dL
Alias
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus Property
C20200
NCI Thesaurus Property-2
C399
NCI Thesaurus ValueDomain
C38046
NCI Thesaurus ValueDomain-2
C25712
UMLS CUI [1]
C0201976
mg/dL
Creatinine ULN
Beskrivning

Creatinine ULN

Datatyp

float

Måttenheter
  • mg/dL
Alias
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus Property
C20200
NCI Thesaurus Property-2
C399
NCI Thesaurus ValueDomain
C25712
NCI Thesaurus ValueDomain-2
C25706
UMLS CUI [1,1]
C0201976
UMLS CUI [1,2]
C1519815
mg/dL
Negative pregnancy test done <=7 days prior to registration, for women of childbearing potential only. (If not a woman of childbearing potential check NA)
Beskrivning

Negative pregnancy test done <=7 days prior to registration, for women of childbearing potential only. (If not a woman of childbearing potential check NA)

Datatyp

boolean

Alias
NCI Thesaurus ValueDomain
C25180
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25247
NCI Metathesaurus Property
C0032976
UMLS CUI [1]
C0232973
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

boolean

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-2
C78209
UMLS 2011AA Property-2
C0085732
Willingness to return to NCCTG enrolling institution for follow-up
Beskrivning

PatientTherapeuticProcedureFollow-upEligibilityDeterminationInd-2

Datatyp

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C16033
UMLS 2011AA Property
C1522577
NCI Thesaurus Property-2
C49236
UMLS 2011AA Property-2
C0087111
NCI Thesaurus Property-3
C25171
UMLS 2011AA Property-3
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

boolean

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C19157
UMLS 2011AA Property
C0370003
NCI Thesaurus Property-2
C25171
UMLS 2011AA Property-2
C0013893
NCI Thesaurus Property-3
C25460
UMLS 2011AA Property-3
C1511481
NCI Thesaurus Property-4
C25340
UMLS 2011AA Property-4
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

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C16112
UMLS 2011AA Property
C1516637
NCI Thesaurus Property-2
C71974
UMLS 2011AA Property-2
C0995150
NCI Thesaurus Property-3
C54264
UMLS 2011AA Property-3
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

boolean

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-2
C48387
UMLS 2011AA Property-2
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

boolean

Alias
NCI Thesaurus ObjectClass
C25190
NCI Thesaurus Property
C25626
NCI Thesaurus Property-2
C9305
NCI Thesaurus Property-3
C8507
NCI Thesaurus Property-4
C16112
NCI Thesaurus ValueDomain
C25180
UMLS CUI [1]
C1513041
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

boolean

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C2985
UMLS 2011AA Property
C0011849
NCI Thesaurus Property-2
C49236
UMLS 2011AA Property-2
C0087111
NCI Thesaurus Property-3
C18772
UMLS 2011AA Property-3
C0262926
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
If HIV positive, CD4 count must be >=400
Beskrivning

LaboratoryProcedureCD4-PositiveT-LymphocyteOutcomeIndicator

Datatyp

boolean

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-2
C12537
UMLS 2011AA Property-2
C0039215
Exclusion Criteria - All Responses In Section Below Must Be "no."
Beskrivning

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

Alias
UMLS CUI-1
C0680251
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

boolean

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-2
C25171
UMLS 2011AA Property-2
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

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C13310
UMLS 2011AA Property
C0205373
NCI Thesaurus Property-2
C2991
UMLS 2011AA Property-2
C0012634
NCI Thesaurus Property-3
C25456
UMLS 2011AA Property-3
C0205420
NCI Thesaurus Property-4
C25370
UMLS 2011AA Property-4
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

boolean

Alias
NCI Thesaurus ValueDomain
C38147
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25370
NCI Thesaurus Property-2
C14139
UMLS CUI [1]
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

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C2991
UMLS 2011AA Property
C0012634
NCI Thesaurus Property-2
C25456
UMLS 2011AA Property-2
C0205420
NCI Thesaurus Property-3
C48932
UMLS 2011AA Property-3
C0205318
NCI Thesaurus Property-4
C25370
UMLS 2011AA Property-4
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

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25608
UMLS 2011AA Property
C0679823
NCI Thesaurus Property-2
C25471
UMLS 2011AA Property-2
C0521116
NCI Thesaurus Property-3
C15207
NCI Thesaurus Property-4
C28041
UMLS 2011AA Property-3
C1517586
NCI Thesaurus Property-5
C25370
UMLS 2011AA Property-4
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

boolean

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-2
C18772
UMLS 2011AA Property-2
C0262926
CNS Lymphoma or cerebrospinal fluid involvement with malignant lymphoma cells
Beskrivning

LymphomaCentralNervousSystemCerebrospinalFluidInvolvementInd-2

Datatyp

boolean

Alias
NCI Thesaurus ObjectClass
C3208
UMLS 2011AA ObjectClass
C0024299
NCI Thesaurus Property
C12438
UMLS 2011AA Property
C3714787
NCI Thesaurus Property-2
C12692
UMLS 2011AA Property-2
C0007806
NCI Thesaurus Property-3
C25548
UMLS 2011AA Property-3
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

boolean

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-2
C15258
UMLS 2011AA ObjectClass-2
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

boolean

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

boolean

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

boolean

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

boolean

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-2
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-2
C41192
UMLS 2011AA Property-2
C1524004
Treatment cannot begin prior to registration and must begin <=14 days after registration
Beskrivning

ClinicalTrialTherapeuticProcedurePostRegistrationChecklistInd-2

Datatyp

boolean

Alias
NCI Thesaurus ObjectClass
C15207
NCI Thesaurus Property
C25646
UMLS 2011AA Property
C1514821
NCI Thesaurus Property-2
C38008
UMLS 2011AA Property-2
C0687676
NCI Thesaurus Property-3
C49236
UMLS 2011AA Property-3
C0087111
NCI Thesaurus Property-4
C49073
UMLS 2011AA Property-4
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

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25646
UMLS 2011AA Property
C1514821
NCI Thesaurus Property-2
C25629
UMLS 2011AA Property-2
C0332152
NCI Thesaurus Property-3
C25294
UMLS 2011AA Property-3
C0022885
NCI Thesaurus Property-4
C45513
UMLS 2011AA Property-4
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-2
C25629
UMLS 2011AA Property-2
C0332152
NCI Thesaurus Property-3
C25294
UMLS 2011AA Property-3
C0022885
NCI Thesaurus Property-4
C25171
UMLS 2011AA Property-4
C0013893
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25431
UMLS 2011AA ValueDomain-2
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-2
C25629
UMLS 2011AA Property-2
C0332152
NCI Thesaurus Property-3
C25294
UMLS 2011AA Property-3
C0022885
NCI Thesaurus Property-4
C25171
UMLS 2011AA Property-4
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

boolean

Alias
NCI Thesaurus ObjectClass
C15207
NCI Thesaurus Property
C25213
UMLS 2011AA Property
C1442488
NCI Thesaurus Property-2
C2991
UMLS 2011AA Property-2
C0012634
NCI Thesaurus Property-3
C25356
UMLS 2011AA Property-3
C1301725
NCI Thesaurus Property-4
C49073
UMLS 2011AA Property-4
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

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25646
UMLS 2011AA Property
C1514821
NCI Thesaurus Property-2
C9305
UMLS 2011AA Property-2
C0006826
NCI Thesaurus Property-3
C25629
UMLS 2011AA Property-3
C0332152
NCI Thesaurus Property-4
C25294
UMLS 2011AA Property-4
C0022885
NCI Thesaurus Property-5
C25171
UMLS 2011AA Property-5
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-2
C9305
UMLS 2011AA Property-2
C0006826
NCI Thesaurus Property-3
C25629
UMLS 2011AA Property-3
C0332152
NCI Thesaurus Property-4
C25294
UMLS 2011AA Property-4
C0022885
NCI Thesaurus Property-5
C25171
UMLS 2011AA Property-5
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

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25646
UMLS 2011AA Property
C1514821
NCI Thesaurus Property-2
C12431
UMLS 2011AA Property-2
C0005953
NCI Thesaurus Property-3
C25629
UMLS 2011AA Property-3
C0332152
NCI Thesaurus Property-4
C25294
UMLS 2011AA Property-4
C0022885
NCI Thesaurus Property-5
C25171
UMLS 2011AA Property-5
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-2
C12431
UMLS 2011AA Property-2
C0005953
NCI Thesaurus Property-3
C25629
UMLS 2011AA Property-3
C0332152
NCI Thesaurus Property-4
C25294
UMLS 2011AA Property-4
C0022885
NCI Thesaurus Property-5
C25171
UMLS 2011AA Property-5
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

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C25581
UMLS 2011AA ObjectClass
C1518419
NCI Thesaurus Property
C15368
NCI Thesaurus ObjectClass-2
C61372
UMLS 2011AA ObjectClass-2
C1273870
Blood draw kit is available on site
Beskrivning

ClinicalTrialBloodSpecimenCollectionAvailabilityChecklistInd-2

Datatyp

boolean

Alias
NCI Thesaurus ObjectClass
C15207
NCI Thesaurus Property
C12434
UMLS 2011AA Property
C0229664
NCI Thesaurus Property-2
C25453
UMLS 2011AA Property-2
C1516698
NCI Thesaurus Property-3
C19157
UMLS 2011AA Property-3
C0370003
NCI Thesaurus Property-4
C25429
UMLS 2011AA Property-4
C0470187
NCI Thesaurus Property-5
C49073
UMLS 2011AA Property-5
C1707357
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Registration Check
Beskrivning

Registration Check

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

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C12434
UMLS 2011AA Property
C0229664
NCI Thesaurus Property-2
C19157
UMLS 2011AA Property-2
C0370003
NCI Thesaurus Property-3
C25460
UMLS 2011AA Property-3
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

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C12801
UMLS 2011AA Property
C0040300
NCI Thesaurus Property-2
C19157
UMLS 2011AA Property-2
C0370003
NCI Thesaurus Property-3
C25460
UMLS 2011AA Property-3
C1511481
NCI Thesaurus Property-4
C16100
UMLS 2011AA Property-4
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

boolean

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C67527
UMLS 2011AA Property
C0016884
NCI Thesaurus Property-2
C9305
UMLS 2011AA Property-2
C0006826
NCI Thesaurus Property-3
C19157
UMLS 2011AA Property-3
C0370003
NCI Thesaurus Property-4
C25460
UMLS 2011AA Property-4
C1511481
NCI Thesaurus Property-5
C16203
UMLS 2011AA Property-5
C1516654
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Patient has given permission to 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

boolean

Alias
NCI Thesaurus ObjectClass
C12801
UMLS 2011AA ObjectClass
C0040300
NCI Thesaurus ObjectClass-2
C12434
UMLS 2011AA ObjectClass-2
C0229664
NCI Thesaurus ObjectClass-3
C19157
UMLS 2011AA ObjectClass-3
C0370003
NCI Thesaurus Property
C17649
UMLS 2011AA Property
C0205394
NCI Thesaurus Property-2
C15319
NCI Thesaurus Property-3
C2991
UMLS 2011AA Property-2
C0012634
NCI Thesaurus Property-4
C25460
UMLS 2011AA Property-3
C1511481
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Patient has given NCCTG permission to give sample(s) to outside researchers
Beskrivning

PersonSpecimenExternalInvestigatorConsentInd-2

Datatyp

boolean

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C44280
UMLS 2011AA Property
C0205101
NCI Thesaurus Property-2
C19157
UMLS 2011AA Property-2
C0370003
NCI Thesaurus Property-3
C25936
UMLS 2011AA Property-3
C0035173
NCI Thesaurus Property-4
C25460
UMLS 2011AA Property-4
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

boolean

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-2
C37948
UMLS 2011AA Property-2
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. StudyEvent: N1085 Eligibility Checklist
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Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Age
Item
18 Years and older
boolean
C38147 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C25150 (NCI Thesaurus Property)
C0001779 (UMLS CUI [1])
Age
Item
Age
integer
C25337 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C25150 (NCI Thesaurus Property)
C0001779 (UMLS CUI [1])
DiffuseLargeB-CellLymphomaClassificationInd-2
Item
Untreated, histological diagnosis of CD20-positive diffuse large B cell lymphoma
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C8851 (NCI Thesaurus ObjectClass)
C0079744 (UMLS 2011AA ObjectClass)
C25161 (NCI Thesaurus Property)
C0008902 (UMLS 2011AA Property)
TumorHistologicallyConfirmedInd-2
Item
Stage II, III, or IV (Ann Arbor Staging: see Appendix II)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25458 (NCI Thesaurus Property)
C0750484 (UMLS 2011AA Property)
EasternCooperativeOncologyGroupPerformanceStatusAssessmentInd-2
Item
ECOG performance status (PS) 0, 1, or 2
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C25491 (NCI Thesaurus ObjectClass)
C1512162 (UMLS 2011AA ObjectClass)
CL092952 (NCI Metathesaurus ObjectClass)
Item
ECOG Performance Status
text
C25664 (NCI Thesaurus ValueDomain)
C0349674 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus Property)
C25491 (NCI Thesaurus ValueDomain-2)
C1512162 (UMLS 2011AA ValueDomain-2)
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)
PatientPriorRegistrationLaboratoryProcedureEligibilityDeterminationInd-2
Item
The following laboratory values obtained <= 14 days prior to registration
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25646 (NCI Thesaurus Property)
C1514821 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property-2)
C0332152 (UMLS 2011AA Property-2)
C25294 (NCI Thesaurus Property-3)
C0022885 (UMLS 2011AA Property-3)
C25171 (NCI Thesaurus Property-4)
C0013893 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
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-2)
C0884358 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25509 (NCI Thesaurus ValueDomain-2)
C1279901 (UMLS 2011AA ValueDomain-2)
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-2)
C0884358 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25577 (NCI Thesaurus ValueDomain-2)
C1513491 (UMLS 2011AA ValueDomain-2)
ANC above 1500/mm3
Item
Absolute neutrophil count (ANC) >=1500/mm3
boolean
C38147 (NCI Thesaurus ValueDomain)
C12533 (NCI Thesaurus Property)
C20200 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
C0948762 (UMLS CUI [1])
Neutrophil count
Item
ANC
float
C25294 (NCI Thesaurus ObjectClass)
C20200 (NCI Thesaurus Property)
C63321 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C0200633 (UMLS CUI [1])
LaboratoryProcedurePost-OperativeElevatedPlateletResultInd-2
Item
Peripheral platelet count (PLT) >=100,000/mm^3
boolean
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25493 (NCI Thesaurus Property)
C0205250 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C12520 (NCI Thesaurus Property-3)
C0005821 (UMLS 2011AA Property-3)
C25623 (NCI Thesaurus Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Platelets
Item
Peripheral Platelet Count
float
C25294 (NCI Thesaurus ObjectClass)
C20200 (NCI Thesaurus Property)
C12520 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C0005821 (UMLS CUI [1])
HematologyHemoglobinAssessmentInd-2
Item
Hemoglobin >9.0 g/dL
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C16673 (NCI Thesaurus ObjectClass)
C0018943 (UMLS 2011AA ObjectClass)
Hemoglobin
Item
Hemoglobin
float
C16676 (NCI Thesaurus Property)
C20200 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C0019046 (UMLS CUI [1])
Total bilirubin below 1.5xULN
Item
Total bilirubin <=1.5 x ULN, or if total bilirubin is >1.5 ULN, the direct bilirubin must be normal
boolean
C25294 (NCI Thesaurus ObjectClass)
C25320 (NCI Thesaurus Property)
C38037 (NCI Thesaurus Property-2)
C25282 (NCI Thesaurus Property-3)
C25706 (NCI Thesaurus Property-4)
C38147 (NCI Thesaurus ValueDomain)
C0201913 (UMLS CUI [1,1])
C1519815 (UMLS CUI [1,2])
LaboratoryProcedureTotalBilirubinResultInd-2
Item
Is total bilirubin >1.5 x ULN (this question may be answered yes or no)
boolean
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-2)
C0201913 (UMLS 2011AA Property-2)
Direct Bilirubin
Item
Direct Bilirubin
float
C25294 (NCI Thesaurus ObjectClass)
C20200 (NCI Thesaurus Property)
C64481 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C0201916 (UMLS CUI [1])
Direct Bilirubin ULN
Item
Direct Bilirubin ULN
float
C25294 (NCI Thesaurus ObjectClass)
C20200 (NCI Thesaurus Property)
C64481 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C0201916 (UMLS CUI [1,1])
C1519815 (UMLS CUI [1,2])
Bilirubin, total
Item
Total Bilirubin
float
C25294 (NCI Thesaurus ObjectClass)
C20200 (NCI Thesaurus Property)
C38037 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C0201913 (UMLS CUI [1])
Bilirubin, total ULN
Item
Total bilirubin ULN
float
C25294 (NCI Thesaurus ObjectClass)
C20200 (NCI Thesaurus Property)
C38037 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C0201913 (UMLS CUI [1,1])
C1519815 (UMLS CUI [1,2])
LaboratoryProcedureAlkalinePhosphataseEligibilityDeterminationInd-2
Item
Alkaline phosphatase <=3 x ULN, unless evidence of direct liver involvement by lymphoma, then <=5 x ULN
boolean
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-2)
C0002059 (UMLS 2011AA Property-2)
LiverInvolvedInd-3
Item
Is there liver involvement (This question can be answered yes or no)
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C12392 (NCI Thesaurus ObjectClass)
C0023884 (UMLS 2011AA ObjectClass)
C25547 (NCI Thesaurus Property)
Alkaline Phosphatase
Item
Alkaline Phosphatase
float
C20200 (NCI Thesaurus Property)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C16276 (NCI Thesaurus Property-2)
C0201850 (UMLS CUI [1])
Alkaline Phosphatase ULN
Item
Alkaline Phosphatase ULN
float
C25294 (NCI Thesaurus ObjectClass)
C20200 (NCI Thesaurus Property)
C16276 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C0151420 (UMLS CUI [1,1])
C1519815 (UMLS CUI [1,2])
AST below 3xULN
Item
SGOT (AST) <=3 x ULN, unless evidence of direct liver involvement by lymphoma, then <=5 x ULN
boolean
C13308 (NCI Thesaurus ObjectClass)
C61018 (NCI Thesaurus ObjectClass-2)
C25320 (NCI Thesaurus Property)
C37984 (NCI Thesaurus Property-2)
C25282 (NCI Thesaurus Property-3)
C25706 (NCI Thesaurus Property-4)
C38147 (NCI Thesaurus ValueDomain)
C0201899 (UMLS CUI [1,1])
C1519815 (UMLS CUI [1,2])
AST
Item
AST (SGOT)
float
C25294 (NCI Thesaurus ObjectClass)
C25202 (NCI Thesaurus Property)
C20200 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C0201899 (UMLS CUI [1])
AST ULN
Item
AST (SGOT) ULN
float
C25294 (NCI Thesaurus ObjectClass)
C25202 (NCI Thesaurus Property)
C20200 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C0242192 (UMLS CUI [1,1])
C1519815 (UMLS CUI [1,2])
LaboratoryProcedureCreatinineResultInd-2
Item
Creatinine <= ULN (mg/dL)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C399 (NCI Thesaurus Property-2)
C0010294 (UMLS 2011AA Property-2)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
Creatinine, Serum
Item
Serum creatinine
float
C25294 (NCI Thesaurus ObjectClass)
C20200 (NCI Thesaurus Property)
C399 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C0201976 (UMLS CUI [1])
Creatinine, Serum ULN
Item
Creatinine ULN
float
C25294 (NCI Thesaurus ObjectClass)
C20200 (NCI Thesaurus Property)
C399 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C0201976 (UMLS CUI [1,1])
C1519815 (UMLS CUI [1,2])
Not pregnant
Item
Negative pregnancy test done <=7 days prior to registration, for women of childbearing potential only. (If not a woman of childbearing potential check NA)
boolean
C25180 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C25247 (NCI Thesaurus Property)
C0032976 (NCI Metathesaurus Property)
C0232973 (UMLS CUI [1])
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)
PatientConsentAbilityInd-2
Item
Provide informed written consent
boolean
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-2)
C0085732 (UMLS 2011AA Property-2)
PatientTherapeuticProcedureFollow-upEligibilityDeterminationInd-2
Item
Willingness to return to NCCTG enrolling institution for follow-up
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C16033 (NCI Thesaurus Property)
C1522577 (UMLS 2011AA Property)
C49236 (NCI Thesaurus Property-2)
C0087111 (UMLS 2011AA Property-2)
C25171 (NCI Thesaurus Property-3)
C0013893 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PersonSpecimenUseConsentEligibilityDeterminationIndicator
Item
Willing to provide mandatory blood samples for correlative research purposes (see Sections 6.241, 14.0)
boolean
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus Property)
C0370003 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property-2)
C0013893 (UMLS 2011AA Property-2)
C25460 (NCI Thesaurus Property-3)
C1511481 (UMLS 2011AA Property-3)
C25340 (NCI Thesaurus Property-4)
C0457083 (UMLS 2011AA Property-4)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
PatientGrapefruitAvoidanceClinicalTrialEligibilityCriteriaInd-2
Item
Willingness to abstain from eating grapefruit or drinking grapefruit juice for the duration of the study
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C16112 (NCI Thesaurus Property)
C1516637 (UMLS 2011AA Property)
C71974 (NCI Thesaurus Property-2)
C0995150 (UMLS 2011AA Property-2)
C54264 (NCI Thesaurus Property-3)
C0870186 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PatientEverolimusClinicalTrialEligibilityCriteriaInd-2
Item
Willingness to take everolimus orally, once daily at the same time every day either consistently with food or consistently without food
boolean
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-2)
C0541315 (UMLS 2011AA Property-2)
Measurable disease
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
boolean
C25190 (NCI Thesaurus ObjectClass)
C25626 (NCI Thesaurus Property)
C9305 (NCI Thesaurus Property-2)
C8507 (NCI Thesaurus Property-3)
C16112 (NCI Thesaurus Property-4)
C25180 (NCI Thesaurus ValueDomain)
C1513041 (UMLS CUI [1])
PersonDiabetesMellitusTherapeuticProcedurePersonalMedicalHistoryInd-2
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)
boolean
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C2985 (NCI Thesaurus Property)
C0011849 (UMLS 2011AA Property)
C49236 (NCI Thesaurus Property-2)
C0087111 (UMLS 2011AA Property-2)
C18772 (NCI Thesaurus Property-3)
C0262926 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
LaboratoryProcedureCD4-PositiveT-LymphocyteOutcomeIndicator
Item
If HIV positive, CD4 count must be >=400
boolean
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-2)
C0039215 (UMLS 2011AA Property-2)
Item Group
Exclusion Criteria - All Responses In Section Below Must Be "no."
C0680251 (UMLS CUI-1)
PatientContraceptionEligibilityDeterminationInd-2
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)
boolean
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-2)
C0013893 (UMLS 2011AA Property-2)
PatientConcurrentSystemicDiseaseorDisorderExclusionCriteriaInd-2
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
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C13310 (NCI Thesaurus Property)
C0205373 (UMLS 2011AA Property)
C2991 (NCI Thesaurus Property-2)
C0012634 (UMLS 2011AA Property-2)
C25456 (NCI Thesaurus Property-3)
C0205420 (UMLS 2011AA Property-3)
C25370 (NCI Thesaurus Property-4)
C0680251 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Immunocompromised patient
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
boolean
C38147 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C25370 (NCI Thesaurus Property)
C14139 (NCI Thesaurus Property-2)
C0085393 (UMLS CUI [1])
PatientUncontrolledConcurrentDiseaseorDisorderExclusionCriteriaInd-2
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
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C2991 (NCI Thesaurus Property)
C0012634 (UMLS 2011AA Property)
C25456 (NCI Thesaurus Property-2)
C0205420 (UMLS 2011AA Property-2)
C48932 (NCI Thesaurus Property-3)
C0205318 (UMLS 2011AA Property-3)
C25370 (NCI Thesaurus Property-4)
C0680251 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PatientInvestigationalClinicalTrialCurrentParticipationExclusionCriteriaInd-2
Item
Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25608 (NCI Thesaurus Property)
C0679823 (UMLS 2011AA Property)
C25471 (NCI Thesaurus Property-2)
C0521116 (UMLS 2011AA Property-2)
C15207 (NCI Thesaurus Property-3)
C28041 (NCI Thesaurus Property-4)
C1517586 (UMLS 2011AA Property-3)
C25370 (NCI Thesaurus Property-5)
C0680251 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PatientNeoplasmPersonalMedicalHistoryInd-2
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
boolean
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-2)
C0262926 (UMLS 2011AA Property-2)
LymphomaCentralNervousSystemCerebrospinalFluidInvolvementInd-2
Item
CNS Lymphoma or cerebrospinal fluid involvement with malignant lymphoma cells
boolean
C3208 (NCI Thesaurus ObjectClass)
C0024299 (UMLS 2011AA ObjectClass)
C12438 (NCI Thesaurus Property)
C3714787 (UMLS 2011AA Property)
C12692 (NCI Thesaurus Property-2)
C0007806 (UMLS 2011AA Property-2)
C25548 (NCI Thesaurus Property-3)
C1314939 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
AttenuatedLiveVirusVaccineImmunizationPlanInd-2
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)
boolean
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-2)
C0020971 (UMLS 2011AA ObjectClass-2)
HepaticInfectionPersonalMedicalHistoryInd-3
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)
boolean
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)
AnticonvulsantMedicationReceivedInd-2
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.)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C459 (NCI Thesaurus ObjectClass)
C0013227 (UMLS 2011AA ObjectClass)
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
Item Group
Pre-registration Check
PatientRegisteredInd-2
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)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25644 (NCI Thesaurus Property)
InformedConsentFormSignedInd-2
Item
Consent form signed and dated
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16468 (NCI Thesaurus ObjectClass)
C0009797 (UMLS 2011AA ObjectClass)
C25679 (NCI Thesaurus Property)
InformedConsentFormSignedDate
Item
Date Informed Consent Signed
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
C16468 (NCI Thesaurus ObjectClass)
C0009797 (UMLS 2011AA ObjectClass)
C25679 (NCI Thesaurus Property)
Item
Authorization for use and disclosure of protected health information signed and dated (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-3)
C1272460 (UMLS 2011AA-4)
HealthInsurancePortabilityandAccountabilityActTissueDonorAuthorizationDate
Item
Date of authorization (If a USA institution)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25168 (NCI Thesaurus Property)
C0040288 (UMLS 2011AA Property)
C62504 (NCI Thesaurus ObjectClass)
C0600593 (UMLS 2011AA ObjectClass)
C41192 (NCI Thesaurus Property-2)
C1524004 (UMLS 2011AA Property-2)
ClinicalTrialTherapeuticProcedurePostRegistrationChecklistInd-2
Item
Treatment cannot begin prior to registration and must begin <=14 days after registration
boolean
C15207 (NCI Thesaurus ObjectClass)
C25646 (NCI Thesaurus Property)
C1514821 (UMLS 2011AA Property)
C38008 (NCI Thesaurus Property-2)
C0687676 (UMLS 2011AA Property-2)
C49236 (NCI Thesaurus Property-3)
C0087111 (UMLS 2011AA Property-3)
C49073 (NCI Thesaurus Property-4)
C1707357 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PatientPriorRegistrationLaboratoryProcedureVerificationInd-2
Item
Pretreatment tests/procedures must be completed <= 14 days prior to registration (see Section 4.0)
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25646 (NCI Thesaurus Property)
C1514821 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property-2)
C0332152 (UMLS 2011AA Property-2)
C25294 (NCI Thesaurus Property-3)
C0022885 (UMLS 2011AA Property-3)
C45513 (NCI Thesaurus Property-4)
C1711411 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
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-2)
C0332152 (UMLS 2011AA Property-2)
C25294 (NCI Thesaurus Property-3)
C0022885 (UMLS 2011AA Property-3)
C25171 (NCI Thesaurus Property-4)
C0013893 (UMLS 2011AA Property-4)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)
C0439659 (UMLS 2011AA ValueDomain-2)
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-2)
C0332152 (UMLS 2011AA Property-2)
C25294 (NCI Thesaurus Property-3)
C0022885 (UMLS 2011AA Property-3)
C25171 (NCI Thesaurus Property-4)
C0013893 (UMLS 2011AA Property-4)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
ClinicalTrialBaselineDiseaseDocumentedChecklistInd-2
Item
All required baseline symptoms (see Section 10.3) must be documented and graded
boolean
C15207 (NCI Thesaurus ObjectClass)
C25213 (NCI Thesaurus Property)
C1442488 (UMLS 2011AA Property)
C2991 (NCI Thesaurus Property-2)
C0012634 (UMLS 2011AA Property-2)
C25356 (NCI Thesaurus Property-3)
C1301725 (UMLS 2011AA Property-3)
C49073 (NCI Thesaurus Property-4)
C1707357 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PatientPriorRegistrationLaboratoryProcedureMalignantNeoplasmEligibilityDeterminationInd-2
Item
Tumor measurement/Evaluation of indicator lesion must be completed <=28 days prior to registration (Exceptions to the above dates)
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25646 (NCI Thesaurus Property)
C1514821 (UMLS 2011AA Property)
C9305 (NCI Thesaurus Property-2)
C0006826 (UMLS 2011AA Property-2)
C25629 (NCI Thesaurus Property-3)
C0332152 (UMLS 2011AA Property-3)
C25294 (NCI Thesaurus Property-4)
C0022885 (UMLS 2011AA Property-4)
C25171 (NCI Thesaurus Property-5)
C0013893 (UMLS 2011AA Property-5)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
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-2)
C0006826 (UMLS 2011AA Property-2)
C25629 (NCI Thesaurus Property-3)
C0332152 (UMLS 2011AA Property-3)
C25294 (NCI Thesaurus Property-4)
C0022885 (UMLS 2011AA Property-4)
C25171 (NCI Thesaurus Property-5)
C0013893 (UMLS 2011AA Property-5)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
PatientPriorRegistrationLaboratoryProcedureBoneMarrowEligibilityDeterminationInd-2
Item
Bone marrow aspirate and biopsy must be completed <=42 days prior to registration (Exceptions to the above dates)
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25646 (NCI Thesaurus Property)
C1514821 (UMLS 2011AA Property)
C12431 (NCI Thesaurus Property-2)
C0005953 (UMLS 2011AA Property-2)
C25629 (NCI Thesaurus Property-3)
C0332152 (UMLS 2011AA Property-3)
C25294 (NCI Thesaurus Property-4)
C0022885 (UMLS 2011AA Property-4)
C25171 (NCI Thesaurus Property-5)
C0013893 (UMLS 2011AA Property-5)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
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-2)
C0005953 (UMLS 2011AA Property-2)
C25629 (NCI Thesaurus Property-3)
C0332152 (UMLS 2011AA Property-3)
C25294 (NCI Thesaurus Property-4)
C0022885 (UMLS 2011AA Property-4)
C25171 (NCI Thesaurus Property-5)
C0013893 (UMLS 2011AA Property-5)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
ManagementNorthCentralCancerTreatmentGroupTherapyInd-2
Item
Treatment on this protocol must commence at an NCCTG institution under the supervision of an NCCTG member physician
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25581 (NCI Thesaurus ObjectClass)
C1518419 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus Property)
C61372 (NCI Thesaurus ObjectClass-2)
C1273870 (UMLS 2011AA ObjectClass-2)
ClinicalTrialBloodSpecimenCollectionAvailabilityChecklistInd-2
Item
Blood draw kit is available on site
boolean
C15207 (NCI Thesaurus ObjectClass)
C12434 (NCI Thesaurus Property)
C0229664 (UMLS 2011AA Property)
C25453 (NCI Thesaurus Property-2)
C1516698 (UMLS 2011AA Property-2)
C19157 (NCI Thesaurus Property-3)
C0370003 (UMLS 2011AA Property-3)
C25429 (NCI Thesaurus Property-4)
C0470187 (UMLS 2011AA Property-4)
C49073 (NCI Thesaurus Property-5)
C1707357 (UMLS 2011AA Property-5)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Item Group
Registration Check
PatientBloodSpecimenConsentInd-2
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.)
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C12434 (NCI Thesaurus Property)
C0229664 (UMLS 2011AA Property)
C19157 (NCI Thesaurus Property-2)
C0370003 (UMLS 2011AA Property-2)
C25460 (NCI Thesaurus Property-3)
C1511481 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PatientCorrelativeStudyTissueSpecimenConsentInd-2
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.)
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C12801 (NCI Thesaurus Property)
C0040300 (UMLS 2011AA Property)
C19157 (NCI Thesaurus Property-2)
C0370003 (UMLS 2011AA Property-2)
C25460 (NCI Thesaurus Property-3)
C1511481 (UMLS 2011AA Property-3)
C16100 (NCI Thesaurus Property-4)
C1511524 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PersonSpecimenMalignantNeoplasmFutureClinicalorResearchActivityConsentInd-2
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)
boolean
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C67527 (NCI Thesaurus Property)
C0016884 (UMLS 2011AA Property)
C9305 (NCI Thesaurus Property-2)
C0006826 (UMLS 2011AA Property-2)
C19157 (NCI Thesaurus Property-3)
C0370003 (UMLS 2011AA Property-3)
C25460 (NCI Thesaurus Property-4)
C1511481 (UMLS 2011AA Property-4)
C16203 (NCI Thesaurus Property-5)
C1516654 (UMLS 2011AA Property-5)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
BloodTissueSpecimenOtherDiseasesandDisordersResearchConsentInd-3
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)
boolean
C12801 (NCI Thesaurus ObjectClass)
C0040300 (UMLS 2011AA ObjectClass)
C12434 (NCI Thesaurus ObjectClass-2)
C0229664 (UMLS 2011AA ObjectClass-2)
C19157 (NCI Thesaurus ObjectClass-3)
C0370003 (UMLS 2011AA ObjectClass-3)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C15319 (NCI Thesaurus Property-2)
C2991 (NCI Thesaurus Property-3)
C0012634 (UMLS 2011AA Property-2)
C25460 (NCI Thesaurus Property-4)
C1511481 (UMLS 2011AA Property-3)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
PersonSpecimenExternalInvestigatorConsentInd-2
Item
Patient has given NCCTG permission to give sample(s) to outside researchers
boolean
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C44280 (NCI Thesaurus Property)
C0205101 (UMLS 2011AA Property)
C19157 (NCI Thesaurus Property-2)
C0370003 (UMLS 2011AA Property-2)
C25936 (NCI Thesaurus Property-3)
C0035173 (UMLS 2011AA Property-3)
C25460 (NCI Thesaurus Property-4)
C1511481 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PatientNorthCentralCancerTreatmentGroupEnrollmentInd-2
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.)
boolean
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-2)
C1516879 (UMLS 2011AA Property-2)
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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