ID

11807

Description

N1087 Eligibility Checklist MK2206, Bendamustine Hydrochloride, and Rituximab in Treating Patients With Relapsed Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A26273FE-467D-4C3E-E040-BB89AD436F0B

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A26273FE-467D-4C3E-E040-BB89AD436F0B

Keywords

Versions (2)
  1. 9/19/12 9/19/12 -
  2. 8/4/15 8/4/15 - Martin Dugas
Uploaded on

August 4, 2015

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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Eligibility CLL N1087 NCT01369849

English

No Instruction available.

1 forms  
  1. StudyEvent: N1087 Eligibility Checklist
    1. No Instruction available.
Required Characteristics
Description

Required Characteristics

18 Years and older
Description

18 Years and older

Data type

boolean

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

Age

Data type

integer

Measurement units
  • years
Alias
NCI Thesaurus ValueDomain
C25337
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25150
UMLS CUI [1]
C0001779
years
Diagnosis of CLL according to the NCI criteria (Cheson, Bennett et al. 1996) (Hallek 2008) or SLL according to the WHO criteria (Harris, 1999). This includes previous documentation of: - Biopsy-proven small lymphocytic lymphoma (Harris, 1999) or - Diagnosis of CLL according to NCI working group criteria (Cheson, 1996 and Hallek 2008) as evidenced by all of the following: - Peripheral blood B cell count of >5 x 109/L consisting of small to moderate size lymphocytes - Immunophenotyping consistent with CLL defined as: o The predominant population of lymphocytes share both B-cell antigens [CD19, CD20 (typically dim expression), or CD23] as well as CD5 in the absence of other pan-T-cell markers (CD3, CD2, etc.) o Clonality as evidenced by kappa or lambda; light chain expression (typically dim immunoglobulin expression) or other genetic method (e.g. IGHV analysis) NOTE: Splenomegaly, hepatomegaly, or lymphadenopathy are not required for the diagnosis of CLL. - Before diagnosing CLL or SLL, mantle cell lymphoma must be excluded by demonstrating a negative FISH analysis for t(11;14)(IgH/CCND1) on peripheral blood or tissue biopsy or negative immunohistochemical stains for cyclin D1 on involved tissue biopsy
Description

ChronicLymphocyticLeukemiaTherapyClinicalTrialEligibilityCriteriaInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass-2
C3163
UMLS 2011AA ObjectClass
C0023434
NCI Thesaurus Property
C16112
UMLS 2011AA Property
C1516637
Demonstrated progression after one or two prior lines of CLL therapy (Note: Rituximab monotherapy does not count as a prior line of therapy)
Description

ChronicLymphocyticLeukemiaDiseaseProgressionClinicalTrialEligibilityCriteriaInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C17747
UMLS 2011AA ObjectClass
C0242656
NCI Thesaurus ObjectClass-2
C3163
UMLS 2011AA ObjectClass-2
C0023434
NCI Thesaurus Property
C16112
UMLS 2011AA Property
C1516637
Progressive disease with any one of the following characteristics based on standard criteria for treatment as defined by the NCI-WG 1996 (Cheson, 1996 and Hallek, 2008). 1. Symptomatic CLL characterized by any one of the following: a. Weight loss >=10% within the previous 6 months b. Extreme fatigue attributed to CLL c. Fevers >100.5 F for 2 weeks without evidence of infection d. Drenching night sweats without evidence of infection 2. Evidence of progressive bone marrow failure with hemoglobin <11 g/dL or platelet count <100 x 109/L 3. Massive or rapidly progressive splenomegaly (>6 cm below left costal margin) 4. Massive (>10 cm) or rapidly progressive lymphadenopathy
Description

PatientProgressiveDiseaseClinicalTrialEligibilityCriteriaInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C35571
UMLS 2011AA Property
C1335499
NCI Thesaurus Property-2
C16112
UMLS 2011AA Property-2
C1516637
Life expectancy >=12 months
Description

PatientLifeExpectancyEligibilityDeterminationInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C37987
UMLS 2011AA Property
C0376558
NCI Thesaurus Property-2
C25171
UMLS 2011AA Property-2
C0013893
NCI Thesaurus Property-3
C25359
UMLS 2011AA Property-3
C0679138
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
ECOG performance status (PS) 0, 1, or 2
Description

EasternCooperativeOncologyGroupPerformanceStatusAssessmentInd-2

Data type

boolean

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

PerformanceStatusAssessmentEasternCooperativeOncologyGroupScale

Data type

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
Description

PatientPriorRegistrationLaboratoryProcedureEligibilityDeterminationInd-2

Data type

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)
Description

LaboratoryProcedureEvaluationPerformedFirstDate

Data type

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)
Description

LaboratoryProcedureEvaluationPerformedMostRecentDate

Data type

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
Total bilirubin <=1.5 x Institutional Upper Limit of Normal (ULN) unless due to Gilbert's disease. If total bilirubin is >1.5 x ULN, a direct bilirubin should be performed and must be <1.5 mg/dL for Gilbert's disease to be diagnosed
Description

LaboratoryProcedureWithinClinicalStudyProtocolUpperLimitofNormalTotalBilirubinMeasurementInd-2

Data type

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
Bilirubin, total
Description

Bilirubin, total

Data type

float

Measurement units
  • 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
Description

Total bilirubin ULN

Data type

float

Measurement units
  • 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
Is total bilirubin >1.5 x ULN (This question may be answered yes or no)
Description

LaboratoryProcedureTotalBilirubinResultInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
NCI Thesaurus Property
C20200
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus Property-2
C38037
UMLS CUI [1]
C0201913
Direct Bilirubin
Description

Direct Bilirubin

Data type

float

Measurement units
  • 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
SGOT (AST) <=2.5 x ULN
Description

SerumAspartateAminotransferaseMeasurementHepaticWithinProtocolUpperLimitofNormalLabInd-2

Data type

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]
C0201899
AST (SGOT)
Description

AST (SGOT)

Data type

float

Measurement units
  • 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
Description

AST (SGOT) ULN

Data type

float

Measurement units
  • 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
SGPT (ALT) <=2.5 X ULN
Description

SerumGlutamicPyruvateTransaminasesHepaticWithinProtocolUpperLimitofNormalLabInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C13308
NCI Thesaurus ObjectClass-2
C25293
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]
C0376147
ALT (SGPT)
Description

ALT (SGPT)

Data type

float

Measurement units
  • U/L
Alias
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus Property
C20200
NCI Thesaurus Property-2
C25293
NCI Thesaurus ValueDomain
C38046
NCI Thesaurus ValueDomain-2
C25712
UMLS CUI [1]
C0201836
U/L
ALT (SGPT) ULN
Description

ALT (SGPT) ULN

Data type

float

Measurement units
  • U/L
Alias
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus Property
C20200
NCI Thesaurus Property-2
C25293
NCI Thesaurus ValueDomain
C25712
NCI Thesaurus ValueDomain-2
C25706
UMLS CUI [1,1]
C0376147
UMLS CUI [1,2]
C1519815
U/L
Creatinine <=1.5 x ULN OR creatinine clearance >=60 mL/min/1.73 m2 for patients with creatinine levels >1.5 x ULN
Description

LaboratoryProcedureCreatinineEligibilityDeterminationind-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C399
UMLS 2011AA Property
C0010294
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property-2
C25171
UMLS 2011AA Property-2
C0013893
Serum creatinine
Description

Serum creatinine

Data type

float

Measurement units
  • 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
Description

Creatinine ULN

Data type

float

Measurement units
  • 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
Is Creatinine >1.5 x ULN (This question may be answered yes or no.)
Description

LaboratoryProcedureCreatinineResultInd-2

Data type

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
Creatinine Clearance
Description

Creatinine Clearance

Data type

float

Measurement units
  • mL/min
Alias
NCI Thesaurus Property
C20200
NCI Thesaurus Property-2
C25747
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus ValueDomain
C25712
UMLS CUI [1]
C0373595
mL/min
Adequate bone marrow function as defined by:-A non-transfused platelet count >=30 X 109/L-Neutrophil count (ANC) >=1 X 109/L-Hemoglobin (Hgb) >=8g/dL (Note: Cytopenias due to bone marrow failure are common in patients with relapsed CLL requiring treatment. Accordingly, normal bone marrow function is NOT required for participation)
Description

PatientBoneMarrowFunctionRequiredInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25518
UMLS 2011AA Property
C0542341
Negative pregnancy test done <=7 days prior to registration, for women of childbearing potential only.
Description

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

Data type

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)
Description

PatientNegativePregnancyTestDate

Data type

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
Ability to complete patient diaries and questionnaire(s) by themselves or with assistance
Description

PatientQuestionnaireCompleteEligibilityDeterminationInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25250
UMLS 2011AA Property
C0205197
NCI Thesaurus Property-2
C17048
UMLS 2011AA Property-2
C0034394
NCI Thesaurus Property-3
C25171
UMLS 2011AA Property-3
C0013893
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Provide informed written consent
Description

PatientConsentAbilityInd-2

Data type

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
Willing to return to NCCTG enrolling institution for follow-up
Description

PatientTherapeuticProcedureFollow-upEligibilityDeterminationInd-2

Data type

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 blood samples for correlative research purposes (see Sections 6.31 and 14.11)
Description

PersonSpecimenUseConsentEligibilityDeterminationIndicator

Data type

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
Willing to provide bone marrow aspirate for correlative research purposes (see Sections 6.31 and 14.11)
Description

PersonBoneMarrowSpecimenConsentInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C12431
UMLS 2011AA Property
C0005953
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
Able to swallow whole tablets (NOTE: Nasogastric or G tube administration is not allowed. Tablets must not be crushed or chewed.)
Description

PatientSwallowingAssessmentInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus Property-2
C38028
UMLS 2011AA Property-2
C0011167
Exclusion Criteria - All Responses In Section Below Must Be "no."
Description

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

Prior treatment with bendamustine
Description

BendamustineAgentAdministeredInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus ObjectClass-2
C73261
UMLS 2011AA ObjectClass-2
C0525079
Prior treatment with any experimental Akt inhibitors
Description

Serine/ThreonineProteinKinaseProteinKinaseInhibitorAgentAdministeredInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus ObjectClass-2
C1404
UMLS 2011AA ObjectClass-2
C1449702
NCI Thesaurus ObjectClass-3
C17325
UMLS 2011AA ObjectClass-3
C0072402
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
More than 1 previous purine nucleoside based-therapy (i.e., fludarabine, pentostatin, cladribine)
Description

PurineNucleosideAgentAdministeredInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus ObjectClass-2
C786
UMLS 2011AA ObjectClass-2
C0034140
NCI Thesaurus ObjectClass-3
C707
UMLS 2011AA ObjectClass-3
C0028621
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
More than 1 previous alkylating agent based-therapy (i.e. cyclophosphamide, chlorambucil)
Description

AlkylatingAgentAdministeredInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C223
UMLS 2011AA ObjectClass
C0002073
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
More than 2 total prior lines of therapy for CLL
Description

PriorChronicLymphoidLeukemiaTherapyAdministeredInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C25629
UMLS 2011AA ObjectClass
C0332152
NCI Thesaurus ObjectClass-2
C15368
NCI Thesaurus ObjectClass-3
C3163
UMLS 2011AA ObjectClass-2
C0023434
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Primary refractory disease as defined by progression while receiving or within 6 months of completion of a chemoimmunotherapy regimen such as fludarabine, cyclophosphamide and rituximab (FCR) or pentostatin, cyclophosphamide and rituximab (PCR)
Description

PersonRefractoryDiseaseExclusionCriteriaInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C25370
UMLS 2011AA Property
C0680251
NCI Thesaurus Property-2
C39752
UMLS 2011AA Property-2
C1514815
Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown. - Pregnant women - Nursing women - Men or women of childbearing potential who are unwilling to employ adequate contraception
Description

PatientContraceptionEligibilityDeterminationInd-2

Data type

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. Including but not limited to the following: - New York Heart Association Class III or IV heart disease - Recent myocardial infarction (<1 month) - Uncontrolled infection - Known infection with the human immunodeficiency virus (HIV/AIDS) and/or patients taking HAART as further severe immunosuppression with this regimen may occur. - Infection with known chronic, active Hepatitis C - Positive serology for Hepatitis B (HB) defined as a positive test for HBsAg. In addition, if negative for HBsAg but HBcAb positive (regardless of HBsAb status), a HB DNA test will be performed and if positive the subject will be excluded. - Uncontrolled diabetes defined as HbA1c >=8 or fasting blood glucose >=140 mg/dL
Description

PatientConcurrentSystemicDiseaseorDisorderExclusionCriteriaInd-2

Data type

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
Any of the following: - History of significant ventricular arrhythmia in the last 5 years including: ventricular tachycardia or ventricular fibrillation - QTc prolongation on baseline ECG (defined as a QTc interval >450 msec for males and QTc interval >470 msec for females - Currently using a medication known to cause prolonged QTc (See Appendix III) which can not be discontinued Note: Other medications with possible risk of prolonged QTc are allowed but should be used with caution. Patients using these medications should be monitored accordingly. See Appendix IV. - Ventricular arrhythmia on baseline ECG (ventricular tachycardia or ventricular fibrillation >= 3 beats in a row). - Second or third degree heart block (NOTE: Because QTc prolongation has been reported in patients taking MK-2206, individuals with the above characteristics may not be enrolled in this study.)
Description

PatientUncontrolledConcurrentDiseaseorDisorderExclusionCriteriaInd-2

Data type

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 concurrently which would be considered as a treatment for the primary neoplasm
Description

PatientInvestigationalClinicalTrialCurrentParticipationExclusionCriteriaInd-2

Data type

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
Other active primary malignancy requiring treatment or limits survival to <24 months
Description

PatientNeoplasmPersonalMedicalHistoryInd-2

Data type

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
Any major surgery <=28 days prior to registration
Description

PersonIntervalLastSurgicalProcedureClinicalTrialEligibilityCriteriaInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C15329
UMLS 2011AA Property
C0543467
NCI Thesaurus Property-2
C25551
UMLS 2011AA Property-2
C1517741
NCI Thesaurus Property-3
C16112
UMLS 2011AA Property-3
C1516637
NCI Thesaurus Property-4
C25543
UMLS 2011AA Property-4
C1272706
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Any radiation therapy <=4 weeks prior to registration
Description

PatientRadiationTherapyPriorRegistrationExclusionCriteriaInd-3b

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25646
UMLS 2011AA Property
C1514821
NCI Thesaurus Property-2
C15313
UMLS 2011AA Property-2
C1522449
NCI Thesaurus Property-3
C25629
UMLS 2011AA Property-3
C0332152
NCI Thesaurus Property-4
C25370
UMLS 2011AA Property-4
C0680251
NCI Thesaurus ValueDomain
C49797
UMLS 2011AA ValueDomain
C1708496
Current use of corticosteroids (EXCEPTION: Low doses of steroids <10 mg of prednisone or equivalent dose of other steroid used for treatment of non-hematologic medical conditions. NOTE: Previous use of corticosteroids is allowed.)
Description

CorticosteroidAdministrationInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C25629
UMLS 2011AA Property
C0332152
NCI Thesaurus ObjectClass
C2322
UMLS 2011AA ObjectClass
C0001617
NCI Thesaurus Property-2
C25382
UMLS 2011AA Property-2
C1521801
Active hemolytic anemia requiring immunosuppressive therapy or other pharmacologic treatment (NOTE: Patients who have a positive Coombs test but no evidence of hemolysis are NOT excluded from participation.)
Description

PersonHemolyticAnemiaExclusionCriteriaInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C34376
UMLS 2011AA Property
C0002878
NCI Thesaurus Property-2
C25370
UMLS 2011AA Property-2
C0680251
Receiving any medications or substances that are strong or moderate inhibitors or inducers of CYP450 3A4. - Use of the following strong or moderate inhibitors are prohibited <=7 days prior to registration: Strong Inhibitors of CYP3A4: o Indinavir o Nelfinavir o Ritonavir o Clarithromycin o Itraconazole o Ketoconazole o Nefazodone o Saquinavir o Telithromycin Moderate Inhibitors of CYP3A4 o Aprepitant o Erythromycin o Fluconazole o Grapefruit juice o Verapamil o Diltiazem
Description

CytochromeP4503A4InhibitionInductionMedicationAdministrationInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C459
UMLS 2011AA ObjectClass
C0013227
NCI Thesaurus ObjectClass-2
C61367
UMLS 2011AA ObjectClass-2
C0205263
NCI Thesaurus ObjectClass-3
C17573
UMLS 2011AA ObjectClass-3
C1142644
NCI Thesaurus ObjectClass-4
C42791
UMLS 2011AA ObjectClass-4
C0021469
NCI Thesaurus Property
C25409
UMLS 2011AA Property
C1533734
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Has patient received any of these strong or moderate inhibitors of CYP3A4
Description

PersonStrongCytochromeP4503A4InductionInhibitionAgentEligibilityDeterminationInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C25190
NCI Thesaurus Property
C61367
NCI Thesaurus Property-2
C1708
NCI Thesaurus Property-3
C25171
NCI Thesaurus Property-4
C17573
NCI Thesaurus Property-5
C42791
NCI Thesaurus Property-6
C62223
NCI Thesaurus ValueDomain
C38147
UMLS CUI [1,1]
C3830624
Latest strong or moderate inhibitor date (P450)
Description

PersonStrongCytochromeP4503A4InductionInhibitionAgentEligibilityDeterminationDate

Data type

date

Measurement units
  • mm/dd/yyyy
Alias
NCI Thesaurus ObjectClass
C25190
NCI Thesaurus Property
C61367
NCI Thesaurus Property-2
C1708
NCI Thesaurus Property-3
C25171
NCI Thesaurus Property-4
C17573
NCI Thesaurus Property-5
C42791
NCI Thesaurus Property-6
C62223
NCI Thesaurus ValueDomain
C25164
UMLS CUI [1,1]
C3830624
UMLS CUI [1,2]
C0011008
mm/dd/yyyy
Receiving any medications or substances that are inducers of CYP450 3A4. - Use of the following inducers is prohibited <=12 days prior to registration: o Efavirenz o Nevirapine o Carbamapezine o Modafinil o Phenobarbital o Phenytoin o Pioglitazone o Rifabutin o Rifampin o St. John's wort
Description

CytochromeP4503A4InductionMedicationAdministrationInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
NCI Thesaurus ObjectClass
C459
NCI Thesaurus ObjectClass-2
C61367
NCI Thesaurus Property
C25409
NCI Thesaurus ObjectClass-3
C17573
UMLS CUI [1,1]
C0205263
UMLS CUI [1,2]
C1142644
Has patient received any of these inducers of CYP3A4 (This question may be answered yes or no.)
Description

PersonCytochromeP4503A4InductionAgentEligibilityDeterminationInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C61367
UMLS 2011AA Property
C0205263
NCI Thesaurus Property-2
C1708
UMLS 2011AA Property-2
C0450442
NCI Thesaurus Property-3
C25171
UMLS 2011AA Property-3
C0013893
NCI Thesaurus Property-4
C17573
UMLS 2011AA Property-4
C1142644
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Latest inducer date (mm/dd/yyyy)
Description

PersonCytochromeP4503A4InductionAgentEligibilityDeterminationDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C61367
UMLS 2011AA Property
C0205263
NCI Thesaurus Property-2
C1708
UMLS 2011AA Property-2
C0450442
NCI Thesaurus Property-3
C25171
UMLS 2011AA Property-3
C0013893
NCI Thesaurus Property-4
C17573
UMLS 2011AA Property-4
C1142644
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Pre-registration Check
Description

Pre-registration Check

A mandatory correlative research component is part of this study for all patients, the patient will be automatically registered onto this component (see Sections 3.18e, 3.18f and 14.11 and 17.4)
Description

PatientRegisteredInd-2

Data type

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
Description

InformedConsentFormSignedInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16468
UMLS 2011AA ObjectClass
C0009797
NCI Thesaurus Property
C25679
Informed Consent Date
Description

Informed Consent Date

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus ObjectClass
C16468
NCI Thesaurus Property
C25679
UMLS CUI [1]
C2985782
Authorization for use and disclosure of protected health information signed and dated (U.S.A, institutions only If not a USA institution check NA)
Description

PatientHealthRecordIndicator

Data type

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)
Description

HealthInsurancePortabilityandAccountabilityActTissueDonorAuthorizationDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C25168
UMLS 2011AA Property
C0040288
NCI Thesaurus ObjectClass
C62504
UMLS 2011AA ObjectClass
C0600593
NCI Thesaurus Property-2
C41192
UMLS 2011AA Property-2
C1524004
Treatment cannot begin prior to registration and must begin <=14 days after registration
Description

ClinicalTrialTherapeuticProcedurePostRegistrationChecklistInd-2

Data type

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)
Description

PatientPriorRegistrationLaboratoryProcedureVerificationInd-2

Data type

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.)
Description

PatientPriorRegistrationLaboratoryProcedureEligibilityDeterminationBeginDate

Data type

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
Description

PatientPriorRegistrationLaboratoryProcedureEligibilityDeterminationEndDate

Data type

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
Immunophenotyping by flow cytometry date (Exceptions to the above dates: - Immunophenotyping by flow cytometry of Peripheral blood all CLL patients or nodal tissue SLL only <90 days prior to registration See Section 4.0.)
Description

ImmunophenotypeFlowCytometryFluorochromeDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C20072
UMLS 2011AA ObjectClass
C0079611
NCI Thesaurus Property
C16585
UMLS 2011AA Property
C0016263
NCI Thesaurus Property-2
C503
UMLS 2011AA Property-2
C0016342
Bone marrow biopsy/aspirate date (Baseline bone marrow biopsy/aspirate <=3 months prior to registration See Section 4.0.)
Description

BoneMarrowEvaluationDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C25214
UMLS 2011AA Property
C0220825
NCI Thesaurus ObjectClass
C12431
UMLS 2011AA ObjectClass
C0005953
CT scan date (CT scan can be performed <=21 days prior to registration.)
Description

DiagnosticComputedTomographyPerformedDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C17204
UMLS 2011AA ObjectClass
C0040405
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus ObjectClass-2
C25482
UMLS 2011AA ObjectClass-2
C0348026
Cytogenetic analysis by FISH date (Cytogenetic analysis by FISH peripheral blood, bone marrow or nodal tissue <90 days prior to registration See Section 4.0.)
Description

FluorescenceinsituHybridizationKaryotypingCytogeneticAnalysisPerformedDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C18280
UMLS 2011AA ObjectClass
C0752095
NCI Thesaurus ObjectClass-2
C17563
UMLS 2011AA ObjectClass-2
C0162789
NCI Thesaurus ObjectClass-3
C16768
UMLS 2011AA ObjectClass-3
C0022526
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
All required baseline symptoms (see Section 10.3) must be documented and graded
Description

ClinicalTrialBaselineDiseaseDocumentedChecklistInd-2

Data type

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
Treatment on this protocol must commence at an NCCTG institution under the supervision of an NCCTG member physician
Description

ManagementNorthCentralCancerTreatmentGroupTherapyInd-2

Data type

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
Study drug is available on site
Description

ProtocolAgentAvailableInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C25320
UMLS 2011AA ObjectClass
C1507394
NCI Thesaurus ObjectClass-2
C1708
UMLS 2011AA ObjectClass-2
C0450442
NCI Thesaurus Property
C25429
UMLS 2011AA Property
C0470187
Blood draw kit is available on site
Description

ClinicalTrialBloodSpecimenCollectionAvailabilityChecklistInd-2

Data type

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
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, the following will be recorded:)
Description

PersonSpecimenMalignantNeoplasmFutureClinicalorResearchActivityConsentInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C25190
NCI Thesaurus Property
C67527
NCI Thesaurus Property-2
C9305
NCI Thesaurus Property-3
C19157
NCI Thesaurus Property-4
C25460
NCI Thesaurus Property-5
C16203
NCI Thesaurus ValueDomain
C38147
UMLS CUI [1,1]
C1511481
UMLS CUI [1,2]
C1516654
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) (At the time of registration, the following will be recorded:)
Description

BloodTissueSpecimenOtherDiseasesandDisordersResearchConsentInd-3

Data type

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 permission for NCCTG to give his/her sample(s) to outside researchers (At the time of registration, the following will be recorded:)
Description

PersonSpecimenExternalInvestigatorConsentInd-2

Data type

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 patients. At the time of registration, willingness to participate will be recorded. This study is the "Was It Worth It" study and must be included in all NCCTG studies. The study must be open and available at each member site participating in the N1087 study. However, a patient can refuse to go on this study and they are still eligible for participating in N1087.)
Description

PatientNorthCentralCancerTreatmentGroupEnrollmentInd-2

Data type

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
Description

Grouping Factor

Grouping Factor
Description

PhaseGroupingFactorType

Data type

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
Subgroup Code
Description

PatientSubgroupCharacteristicsStratificationDescriptionType

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ObjectClass-2
C25693
UMLS 2011AA ObjectClass-2
C1515021
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
NCI Thesaurus Property-2
C25689
UMLS 2011AA Property-2
C1514983
NCI Thesaurus Property-3
C25447
UMLS 2011AA Property-3
C1521970
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
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1 forms
  1. StudyEvent: N1087 Eligibility Checklist
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
ChronicLymphocyticLeukemiaTherapyClinicalTrialEligibilityCriteriaInd-2
Item
Diagnosis of CLL according to the NCI criteria (Cheson, Bennett et al. 1996) (Hallek 2008) or SLL according to the WHO criteria (Harris, 1999). This includes previous documentation of: - Biopsy-proven small lymphocytic lymphoma (Harris, 1999) or - Diagnosis of CLL according to NCI working group criteria (Cheson, 1996 and Hallek 2008) as evidenced by all of the following: - Peripheral blood B cell count of >5 x 109/L consisting of small to moderate size lymphocytes - Immunophenotyping consistent with CLL defined as: o The predominant population of lymphocytes share both B-cell antigens [CD19, CD20 (typically dim expression), or CD23] as well as CD5 in the absence of other pan-T-cell markers (CD3, CD2, etc.) o Clonality as evidenced by kappa or lambda; light chain expression (typically dim immunoglobulin expression) or other genetic method (e.g. IGHV analysis) NOTE: Splenomegaly, hepatomegaly, or lymphadenopathy are not required for the diagnosis of CLL. - Before diagnosing CLL or SLL, mantle cell lymphoma must be excluded by demonstrating a negative FISH analysis for t(11;14)(IgH/CCND1) on peripheral blood or tissue biopsy or negative immunohistochemical stains for cyclin D1 on involved tissue biopsy
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C3163 (NCI Thesaurus ObjectClass-2)
C0023434 (UMLS 2011AA ObjectClass)
C16112 (NCI Thesaurus Property)
C1516637 (UMLS 2011AA Property)
ChronicLymphocyticLeukemiaDiseaseProgressionClinicalTrialEligibilityCriteriaInd-2
Item
Demonstrated progression after one or two prior lines of CLL therapy (Note: Rituximab monotherapy does not count as a prior line of therapy)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C17747 (NCI Thesaurus ObjectClass)
C0242656 (UMLS 2011AA ObjectClass)
C3163 (NCI Thesaurus ObjectClass-2)
C0023434 (UMLS 2011AA ObjectClass-2)
C16112 (NCI Thesaurus Property)
C1516637 (UMLS 2011AA Property)
PatientProgressiveDiseaseClinicalTrialEligibilityCriteriaInd-2
Item
Progressive disease with any one of the following characteristics based on standard criteria for treatment as defined by the NCI-WG 1996 (Cheson, 1996 and Hallek, 2008). 1. Symptomatic CLL characterized by any one of the following: a. Weight loss >=10% within the previous 6 months b. Extreme fatigue attributed to CLL c. Fevers >100.5 F for 2 weeks without evidence of infection d. Drenching night sweats without evidence of infection 2. Evidence of progressive bone marrow failure with hemoglobin <11 g/dL or platelet count <100 x 109/L 3. Massive or rapidly progressive splenomegaly (>6 cm below left costal margin) 4. Massive (>10 cm) or rapidly progressive lymphadenopathy
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C35571 (NCI Thesaurus Property)
C1335499 (UMLS 2011AA Property)
C16112 (NCI Thesaurus Property-2)
C1516637 (UMLS 2011AA Property-2)
PatientLifeExpectancyEligibilityDeterminationInd-2
Item
Life expectancy >=12 months
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C37987 (NCI Thesaurus Property)
C0376558 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property-2)
C0013893 (UMLS 2011AA Property-2)
C25359 (NCI Thesaurus Property-3)
C0679138 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
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.7
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)
Total bilirubin below 1.5xULN
Item
Total bilirubin <=1.5 x Institutional Upper Limit of Normal (ULN) unless due to Gilbert's disease. If total bilirubin is >1.5 x ULN, a direct bilirubin should be performed and must be <1.5 mg/dL for Gilbert's disease to be diagnosed
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])
Bilirubin, total
Item
Bilirubin, total
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])
Bilirubin, total above 1.5xULN
Item
Is total bilirubin >1.5 x ULN (This question may be answered yes or no)
boolean
C38147 (NCI Thesaurus ValueDomain)
C20200 (NCI Thesaurus Property)
C25294 (NCI Thesaurus ObjectClass)
C38037 (NCI Thesaurus Property-2)
C0201913 (UMLS CUI [1])
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])
AST below 2.5xULN
Item
SGOT (AST) <=2.5 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])
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])
ALT below 2.5xULN
Item
SGPT (ALT) <=2.5 X ULN
boolean
C13308 (NCI Thesaurus ObjectClass)
C25293 (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)
C0376147 (UMLS CUI [1])
ALT
Item
ALT (SGPT)
float
C25294 (NCI Thesaurus ObjectClass)
C20200 (NCI Thesaurus Property)
C25293 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C0201836 (UMLS CUI [1])
ALT ULN
Item
ALT (SGPT) ULN
float
C25294 (NCI Thesaurus ObjectClass)
C20200 (NCI Thesaurus Property)
C25293 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C0376147 (UMLS CUI [1,1])
C1519815 (UMLS CUI [1,2])
LaboratoryProcedureCreatinineEligibilityDeterminationind-2
Item
Creatinine <=1.5 x ULN OR creatinine clearance >=60 mL/min/1.73 m2 for patients with creatinine levels >1.5 x ULN
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C399 (NCI Thesaurus Property)
C0010294 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25171 (NCI Thesaurus Property-2)
C0013893 (UMLS 2011AA Property-2)
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])
LaboratoryProcedureCreatinineResultInd-2
Item
Is Creatinine >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)
C399 (NCI Thesaurus Property-2)
C0010294 (UMLS 2011AA Property-2)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
Creatinine Clearance
Item
Creatinine Clearance
float
C20200 (NCI Thesaurus Property)
C25747 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C0373595 (UMLS CUI [1])
PatientBoneMarrowFunctionRequiredInd-2
Item
Adequate bone marrow function as defined by:-A non-transfused platelet count >=30 X 109/L-Neutrophil count (ANC) >=1 X 109/L-Hemoglobin (Hgb) >=8g/dL (Note: Cytopenias due to bone marrow failure are common in patients with relapsed CLL requiring treatment. Accordingly, normal bone marrow function is NOT required for participation)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25518 (NCI Thesaurus Property)
C0542341 (UMLS 2011AA Property)
Not pregnant
Item
Negative pregnancy test done <=7 days prior to registration, for women of childbearing potential only.
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)
PatientQuestionnaireCompleteEligibilityDeterminationInd-2
Item
Ability to complete patient diaries and questionnaire(s) by themselves or with assistance
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C17048 (NCI Thesaurus Property-2)
C0034394 (UMLS 2011AA Property-2)
C25171 (NCI Thesaurus Property-3)
C0013893 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
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
Willing 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 blood samples for correlative research purposes (see Sections 6.31 and 14.11)
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)
PersonBoneMarrowSpecimenConsentInd-2
Item
Willing to provide bone marrow aspirate for correlative research purposes (see Sections 6.31 and 14.11)
boolean
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C12431 (NCI Thesaurus Property)
C0005953 (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)
PatientSwallowingAssessmentInd-2
Item
Able to swallow whole tablets (NOTE: Nasogastric or G tube administration is not allowed. Tablets must not be crushed or chewed.)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C38028 (NCI Thesaurus Property-2)
C0011167 (UMLS 2011AA Property-2)
Item Group
Exclusion Criteria - All Responses In Section Below Must Be "no."
BendamustineAgentAdministeredInd-2
Item
Prior treatment with bendamustine
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C73261 (NCI Thesaurus ObjectClass-2)
C0525079 (UMLS 2011AA ObjectClass-2)
Serine/ThreonineProteinKinaseProteinKinaseInhibitorAgentAdministeredInd-2
Item
Prior treatment with any experimental Akt inhibitors
boolean
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C1404 (NCI Thesaurus ObjectClass-2)
C1449702 (UMLS 2011AA ObjectClass-2)
C17325 (NCI Thesaurus ObjectClass-3)
C0072402 (UMLS 2011AA ObjectClass-3)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PurineNucleosideAgentAdministeredInd-2
Item
More than 1 previous purine nucleoside based-therapy (i.e., fludarabine, pentostatin, cladribine)
boolean
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C786 (NCI Thesaurus ObjectClass-2)
C0034140 (UMLS 2011AA ObjectClass-2)
C707 (NCI Thesaurus ObjectClass-3)
C0028621 (UMLS 2011AA ObjectClass-3)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
AlkylatingAgentAdministeredInd-2
Item
More than 1 previous alkylating agent based-therapy (i.e. cyclophosphamide, chlorambucil)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C223 (NCI Thesaurus ObjectClass)
C0002073 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
PriorChronicLymphoidLeukemiaTherapyAdministeredInd-2
Item
More than 2 total prior lines of therapy for CLL
boolean
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ObjectClass-2)
C3163 (NCI Thesaurus ObjectClass-3)
C0023434 (UMLS 2011AA ObjectClass-2)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PersonRefractoryDiseaseExclusionCriteriaInd-2
Item
Primary refractory disease as defined by progression while receiving or within 6 months of completion of a chemoimmunotherapy regimen such as fludarabine, cyclophosphamide and rituximab (FCR) or pentostatin, cyclophosphamide and rituximab (PCR)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25370 (NCI Thesaurus Property)
C0680251 (UMLS 2011AA Property)
C39752 (NCI Thesaurus Property-2)
C1514815 (UMLS 2011AA Property-2)
PatientContraceptionEligibilityDeterminationInd-2
Item
Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown. - Pregnant women - Nursing women - Men or women of childbearing potential who are unwilling to employ adequate contraception
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. Including but not limited to the following: - New York Heart Association Class III or IV heart disease - Recent myocardial infarction (<1 month) - Uncontrolled infection - Known infection with the human immunodeficiency virus (HIV/AIDS) and/or patients taking HAART as further severe immunosuppression with this regimen may occur. - Infection with known chronic, active Hepatitis C - Positive serology for Hepatitis B (HB) defined as a positive test for HBsAg. In addition, if negative for HBsAg but HBcAb positive (regardless of HBsAb status), a HB DNA test will be performed and if positive the subject will be excluded. - Uncontrolled diabetes defined as HbA1c >=8 or fasting blood glucose >=140 mg/dL
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)
PatientUncontrolledConcurrentDiseaseorDisorderExclusionCriteriaInd-2
Item
Any of the following: - History of significant ventricular arrhythmia in the last 5 years including: ventricular tachycardia or ventricular fibrillation - QTc prolongation on baseline ECG (defined as a QTc interval >450 msec for males and QTc interval >470 msec for females - Currently using a medication known to cause prolonged QTc (See Appendix III) which can not be discontinued Note: Other medications with possible risk of prolonged QTc are allowed but should be used with caution. Patients using these medications should be monitored accordingly. See Appendix IV. - Ventricular arrhythmia on baseline ECG (ventricular tachycardia or ventricular fibrillation >= 3 beats in a row). - Second or third degree heart block (NOTE: Because QTc prolongation has been reported in patients taking MK-2206, individuals with the above characteristics may not be enrolled in this study.)
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 concurrently 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
Other active primary malignancy requiring treatment or limits survival to <24 months
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)
PersonIntervalLastSurgicalProcedureClinicalTrialEligibilityCriteriaInd-2
Item
Any major surgery <=28 days prior to registration
boolean
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C15329 (NCI Thesaurus Property)
C0543467 (UMLS 2011AA Property)
C25551 (NCI Thesaurus Property-2)
C1517741 (UMLS 2011AA Property-2)
C16112 (NCI Thesaurus Property-3)
C1516637 (UMLS 2011AA Property-3)
C25543 (NCI Thesaurus Property-4)
C1272706 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PatientRadiationTherapyPriorRegistrationExclusionCriteriaInd-3b
Item
Any radiation therapy <=4 weeks prior to registration
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25646 (NCI Thesaurus Property)
C1514821 (UMLS 2011AA Property)
C15313 (NCI Thesaurus Property-2)
C1522449 (UMLS 2011AA Property-2)
C25629 (NCI Thesaurus Property-3)
C0332152 (UMLS 2011AA Property-3)
C25370 (NCI Thesaurus Property-4)
C0680251 (UMLS 2011AA Property-4)
C49797 (NCI Thesaurus ValueDomain)
C1708496 (UMLS 2011AA ValueDomain)
CorticosteroidAdministrationInd-3
Item
Current use of corticosteroids (EXCEPTION: Low doses of steroids <10 mg of prednisone or equivalent dose of other steroid used for treatment of non-hematologic medical conditions. NOTE: Previous use of corticosteroids is allowed.)
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C2322 (NCI Thesaurus ObjectClass)
C0001617 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
PersonHemolyticAnemiaExclusionCriteriaInd-2
Item
Active hemolytic anemia requiring immunosuppressive therapy or other pharmacologic treatment (NOTE: Patients who have a positive Coombs test but no evidence of hemolysis are NOT excluded from participation.)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C34376 (NCI Thesaurus Property)
C0002878 (UMLS 2011AA Property)
C25370 (NCI Thesaurus Property-2)
C0680251 (UMLS 2011AA Property-2)
CytochromeP4503A4InhibitionInductionMedicationAdministrationInd-2
Item
Receiving any medications or substances that are strong or moderate inhibitors or inducers of CYP450 3A4. - Use of the following strong or moderate inhibitors are prohibited <=7 days prior to registration: Strong Inhibitors of CYP3A4: o Indinavir o Nelfinavir o Ritonavir o Clarithromycin o Itraconazole o Ketoconazole o Nefazodone o Saquinavir o Telithromycin Moderate Inhibitors of CYP3A4 o Aprepitant o Erythromycin o Fluconazole o Grapefruit juice o Verapamil o Diltiazem
boolean
C459 (NCI Thesaurus ObjectClass)
C0013227 (UMLS 2011AA ObjectClass)
C61367 (NCI Thesaurus ObjectClass-2)
C0205263 (UMLS 2011AA ObjectClass-2)
C17573 (NCI Thesaurus ObjectClass-3)
C1142644 (UMLS 2011AA ObjectClass-3)
C42791 (NCI Thesaurus ObjectClass-4)
C0021469 (UMLS 2011AA ObjectClass-4)
C25409 (NCI Thesaurus Property)
C1533734 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Cytochrome P450 3A4 Inhibitor
Item
Has patient received any of these strong or moderate inhibitors of CYP3A4
boolean
C25190 (NCI Thesaurus ObjectClass)
C61367 (NCI Thesaurus Property)
C1708 (NCI Thesaurus Property-2)
C25171 (NCI Thesaurus Property-3)
C17573 (NCI Thesaurus Property-4)
C42791 (NCI Thesaurus Property-5)
C62223 (NCI Thesaurus Property-6)
C38147 (NCI Thesaurus ValueDomain)
C3830624 (UMLS CUI [1,1])
Latest Cytochrome P450 3A4 inhibitor date
Item
Latest strong or moderate inhibitor date (P450)
date
C25190 (NCI Thesaurus ObjectClass)
C61367 (NCI Thesaurus Property)
C1708 (NCI Thesaurus Property-2)
C25171 (NCI Thesaurus Property-3)
C17573 (NCI Thesaurus Property-4)
C42791 (NCI Thesaurus Property-5)
C62223 (NCI Thesaurus Property-6)
C25164 (NCI Thesaurus ValueDomain)
C3830624 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Inducers of CYP450 3A4
Item
Receiving any medications or substances that are inducers of CYP450 3A4. - Use of the following inducers is prohibited <=12 days prior to registration: o Efavirenz o Nevirapine o Carbamapezine o Modafinil o Phenobarbital o Phenytoin o Pioglitazone o Rifabutin o Rifampin o St. John's wort
boolean
C38147 (NCI Thesaurus ValueDomain)
C459 (NCI Thesaurus ObjectClass)
C61367 (NCI Thesaurus ObjectClass-2)
C25409 (NCI Thesaurus Property)
C17573 (NCI Thesaurus ObjectClass-3)
C0205263 (UMLS CUI [1,1])
C1142644 (UMLS CUI [1,2])
PersonCytochromeP4503A4InductionAgentEligibilityDeterminationInd-2
Item
Has patient received any of these inducers of CYP3A4 (This question may be answered yes or no.)
boolean
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C61367 (NCI Thesaurus Property)
C0205263 (UMLS 2011AA Property)
C1708 (NCI Thesaurus Property-2)
C0450442 (UMLS 2011AA Property-2)
C25171 (NCI Thesaurus Property-3)
C0013893 (UMLS 2011AA Property-3)
C17573 (NCI Thesaurus Property-4)
C1142644 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PersonCytochromeP4503A4InductionAgentEligibilityDeterminationDate
Item
Latest inducer date (mm/dd/yyyy)
date
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C61367 (NCI Thesaurus Property)
C0205263 (UMLS 2011AA Property)
C1708 (NCI Thesaurus Property-2)
C0450442 (UMLS 2011AA Property-2)
C25171 (NCI Thesaurus Property-3)
C0013893 (UMLS 2011AA Property-3)
C17573 (NCI Thesaurus Property-4)
C1142644 (UMLS 2011AA Property-4)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
Item Group
Pre-registration Check
PatientRegisteredInd-2
Item
A mandatory correlative research component is part of this study for all patients, the patient will be automatically registered onto this component (see Sections 3.18e, 3.18f and 14.11 and 17.4)
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)
Informed Consent Date
Item
Informed Consent Date
date
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
C16468 (NCI Thesaurus ObjectClass)
C25679 (NCI Thesaurus Property)
C2985782 (UMLS CUI [1])
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.44
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)
ImmunophenotypeFlowCytometryFluorochromeDate
Item
Immunophenotyping by flow cytometry date (Exceptions to the above dates: - Immunophenotyping by flow cytometry of Peripheral blood all CLL patients or nodal tissue SLL only <90 days prior to registration See Section 4.0.)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C20072 (NCI Thesaurus ObjectClass)
C0079611 (UMLS 2011AA ObjectClass)
C16585 (NCI Thesaurus Property)
C0016263 (UMLS 2011AA Property)
C503 (NCI Thesaurus Property-2)
C0016342 (UMLS 2011AA Property-2)
BoneMarrowEvaluationDate
Item
Bone marrow biopsy/aspirate date (Baseline bone marrow biopsy/aspirate <=3 months prior to registration See Section 4.0.)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25214 (NCI Thesaurus Property)
C0220825 (UMLS 2011AA Property)
C12431 (NCI Thesaurus ObjectClass)
C0005953 (UMLS 2011AA ObjectClass)
DiagnosticComputedTomographyPerformedDate
Item
CT scan date (CT scan can be performed <=21 days prior to registration.)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C17204 (NCI Thesaurus ObjectClass)
C0040405 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25482 (NCI Thesaurus ObjectClass-2)
C0348026 (UMLS 2011AA ObjectClass-2)
FluorescenceinsituHybridizationKaryotypingCytogeneticAnalysisPerformedDate
Item
Cytogenetic analysis by FISH date (Cytogenetic analysis by FISH peripheral blood, bone marrow or nodal tissue <90 days prior to registration See Section 4.0.)
date
C18280 (NCI Thesaurus ObjectClass)
C0752095 (UMLS 2011AA ObjectClass)
C17563 (NCI Thesaurus ObjectClass-2)
C0162789 (UMLS 2011AA ObjectClass-2)
C16768 (NCI Thesaurus ObjectClass-3)
C0022526 (UMLS 2011AA ObjectClass-3)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
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)
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)
ProtocolAgentAvailableInd-2
Item
Study drug is available on site
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ObjectClass-2)
C0450442 (UMLS 2011AA ObjectClass-2)
C25429 (NCI Thesaurus Property)
C0470187 (UMLS 2011AA Property)
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)
permission research
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, the following will be recorded:)
boolean
C25190 (NCI Thesaurus ObjectClass)
C67527 (NCI Thesaurus Property)
C9305 (NCI Thesaurus Property-2)
C19157 (NCI Thesaurus Property-3)
C25460 (NCI Thesaurus Property-4)
C16203 (NCI Thesaurus Property-5)
C38147 (NCI Thesaurus ValueDomain)
C1511481 (UMLS CUI [1,1])
C1516654 (UMLS CUI [1,2])
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) (At the time of registration, the following will be recorded:)
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 permission for NCCTG to give his/her sample(s) to outside researchers (At the time of registration, the following will be recorded:)
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 patients. At the time of registration, willingness to participate will be recorded. This study is the "Was It Worth It" study and must be included in all NCCTG studies. The study must be open and available at each member site participating in the N1087 study. However, a patient can refuse to go on this study and they are still eligible for participating in N1087.)
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
Grouping Factor
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.55
Code List
Grouping Factor
CL Item
Phase I (Phase I)
CL Item
Phase Ii (Phase II)
Item
Subgroup Code
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25693 (NCI Thesaurus ObjectClass-2)
C1515021 (UMLS 2011AA ObjectClass-2)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
C25689 (NCI Thesaurus Property-2)
C1514983 (UMLS 2011AA Property-2)
C25447 (NCI Thesaurus Property-3)
C1521970 (UMLS 2011AA Property-3)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.56
Code List
Subgroup Code
CL Item
Sg1 - Phase I (SG1 - Phase I)
CL Item
Sg2 - Phase Ii (SG2 - Phase II)
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