ID

11807

Beschrijving

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

Trefwoorden

Klinische Studie [Dokumenttyp]

D004608

M9800/3

19-09-12 19-09-12 -
04-08-15 04-08-15 - Martin Dugas

Geüploaded op

4 augustus 2015

DOI

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Licentie

Creative Commons BY-NC 3.0 Legacy

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Eligibility CLL N1087 NCT01369849

model
Details

No Instruction available.

1 Formulieren

StudyEvent: N1087 Eligibility Checklist
1. No Instruction available.

Name

Type

Description | Question | Decode (Coded Value)

Datatype

Alias

Inclusion Criteria - All responses in this section below must be "Yes."

Item Group

Required Characteristics

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)

PerformanceStatusAssessmentEasternCooperativeOncologyGroupScale

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)

Exclusion Criteria - All responses in section below must be "No."

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)

Registration Check

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])

PatientHealthRecordIndicator

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)

Grouping Factor

Item Group

Grouping Factor

PhaseGroupingFactorType

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)

PatientSubgroupCharacteristicsStratificationDescriptionType

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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Eligibility CLL N1087 NCT01369849

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