Informações:
Falhas:
ID
30182
Descrição
CLL-Irl Study. ICORG 07-01, V7; ODM derived from: https://clinicaltrials.gov/show/NCT00812669
Link
https://clinicaltrials.gov/show/NCT00812669
Palavras-chave
Versões (1)
- 18/05/2018 18/05/2018 -
Titular dos direitos
See clinicaltrials.gov
Transferido a
18 de maio de 2018
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Leukemia NCT00812669
Eligibility Leukemia NCT00812669
- StudyEvent: Eligibility
Similar models
Eligibility Leukemia NCT00812669
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Chronic Lymphocytic Leukemia
Item
diagnosis of chronic lymphocytic leukemia
boolean
C0023434 (UMLS CUI [1])
Progressive Disease Binet Staging System
Item
stage i-iv disease (binet stage progressive a, b, c)
boolean
C1335499 (UMLS CUI [1,1])
C1511118 (UMLS CUI [1,2])
C1511118 (UMLS CUI [1,2])
Cell positive for CD5 antigen | Cell positive for CD23 antigen
Item
cd5 and cd23 positive
boolean
C0882892 (UMLS CUI [1])
C0945924 (UMLS CUI [2])
C0945924 (UMLS CUI [2])
Disease untreated | Recurrent disease Post Combination Chemotherapy | Disease Resistant Post Combination Chemotherapy | Recurrent disease Post Rituximab | Disease Resistant Post Rituximab
Item
untreated or relapsed/resistant disease after combination chemotherapy or rituximab
boolean
C0012634 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C0277556 (UMLS CUI [2,1])
C0687676 (UMLS CUI [2,2])
C1521750 (UMLS CUI [2,3])
C0012634 (UMLS CUI [3,1])
C0332325 (UMLS CUI [3,2])
C0687676 (UMLS CUI [3,3])
C1521750 (UMLS CUI [3,4])
C0277556 (UMLS CUI [4,1])
C0687676 (UMLS CUI [4,2])
C0393022 (UMLS CUI [4,3])
C0012634 (UMLS CUI [5,1])
C0332325 (UMLS CUI [5,2])
C0687676 (UMLS CUI [5,3])
C0393022 (UMLS CUI [5,4])
C0332155 (UMLS CUI [1,2])
C0277556 (UMLS CUI [2,1])
C0687676 (UMLS CUI [2,2])
C1521750 (UMLS CUI [2,3])
C0012634 (UMLS CUI [3,1])
C0332325 (UMLS CUI [3,2])
C0687676 (UMLS CUI [3,3])
C1521750 (UMLS CUI [3,4])
C0277556 (UMLS CUI [4,1])
C0687676 (UMLS CUI [4,2])
C0393022 (UMLS CUI [4,3])
C0012634 (UMLS CUI [5,1])
C0332325 (UMLS CUI [5,2])
C0687676 (UMLS CUI [5,3])
C0393022 (UMLS CUI [5,4])
Exclusion Loss of Chromosome 17p
Item
no 17p deletion
boolean
C2828389 (UMLS CUI [1,1])
C1517965 (UMLS CUI [1,2])
C1517965 (UMLS CUI [1,2])
Client Characteristics
Item
patient characteristics:
boolean
C0815172 (UMLS CUI [1])
WHO performance status scale
Item
who performance status 0-2
boolean
C1298650 (UMLS CUI [1])
Life Expectancy
Item
life expectancy > 1 year
boolean
C0023671 (UMLS CUI [1])
Creatinine clearance measurement
Item
creatinine clearance ≥ 50 ml/min
boolean
C0373595 (UMLS CUI [1])
HIV negative
Item
hiv negative
boolean
C0481430 (UMLS CUI [1])
Pregnancy Absent | Breast Feeding Absent
Item
not pregnant or nursing
boolean
C0032961 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0006147 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0332197 (UMLS CUI [1,2])
C0006147 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Pregnancy test negative
Item
negative pregnancy test
boolean
C0427780 (UMLS CUI [1])
Fertility Contraceptive methods
Item
fertile patients must use effective contraception
boolean
C0015895 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,2])
Exclusion Cancer Other | Exception Cervical cancer Noninvasive | Exception Skin carcinoma Localized
Item
no other concurrent malignancy except for noninvasive cervical cancer or localized nonmelanomatous skin cancer
boolean
C2828389 (UMLS CUI [1,1])
C1707251 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C4048328 (UMLS CUI [2,2])
C2986496 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0699893 (UMLS CUI [3,2])
C0392752 (UMLS CUI [3,3])
C1707251 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C4048328 (UMLS CUI [2,2])
C2986496 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0699893 (UMLS CUI [3,2])
C0392752 (UMLS CUI [3,3])
Exclusion Anaphylaxis Murine-Derived Monoclonal Antibodies Humanized
Item
no history of anaphylaxis to mouse-derived humanized monoclonal antibody
boolean
C2828389 (UMLS CUI [1,1])
C0002792 (UMLS CUI [1,2])
C2916903 (UMLS CUI [1,3])
C2985546 (UMLS CUI [1,4])
C0002792 (UMLS CUI [1,2])
C2916903 (UMLS CUI [1,3])
C2985546 (UMLS CUI [1,4])
Exclusion Criteria | Comorbidity Severe | Heart Diseases | Lung diseases | Mental disorders Interfere with Study Subject Participation Status
Item
no other severe concurrent (e.g., cardiac or pulmonary) diseases or mental disorders that could interfere with ability to participate in the study
boolean
C0680251 (UMLS CUI [1])
C0009488 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0018799 (UMLS CUI [3])
C0024115 (UMLS CUI [4])
C0004936 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C2348568 (UMLS CUI [5,3])
C0009488 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0018799 (UMLS CUI [3])
C0024115 (UMLS CUI [4])
C0004936 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C2348568 (UMLS CUI [5,3])
Therapeutic procedure
Item
prior concurrent therapy:
boolean
C0087111 (UMLS CUI [1])
ID.18
Item
see disease characteristics
boolean