ID

30182

Descripción

CLL-Irl Study. ICORG 07-01, V7; ODM derived from: https://clinicaltrials.gov/show/NCT00812669

Link

https://clinicaltrials.gov/show/NCT00812669

Palabras clave

Versiones (1)
  1. 18/5/18 18/5/18 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

18 de mayo de 2018

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Leukemia NCT00812669

Inglés

Eligibility Leukemia NCT00812669

1 formularios  
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00812669
Criteria
Descripción

Criteria

diagnosis of chronic lymphocytic leukemia
Descripción

Chronic Lymphocytic Leukemia

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023434
stage i-iv disease (binet stage progressive a, b, c)
Descripción

Progressive Disease Binet Staging System

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1335499
UMLS CUI [1,2]
C1511118
cd5 and cd23 positive
Descripción

Cell positive for CD5 antigen | Cell positive for CD23 antigen

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0882892
UMLS CUI [2]
C0945924
untreated or relapsed/resistant disease after combination chemotherapy or rituximab
Descripción

Disease untreated | Recurrent disease Post Combination Chemotherapy | Disease Resistant Post Combination Chemotherapy | Recurrent disease Post Rituximab | Disease Resistant Post Rituximab

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0332155
UMLS CUI [2,1]
C0277556
UMLS CUI [2,2]
C0687676
UMLS CUI [2,3]
C1521750
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C0332325
UMLS CUI [3,3]
C0687676
UMLS CUI [3,4]
C1521750
UMLS CUI [4,1]
C0277556
UMLS CUI [4,2]
C0687676
UMLS CUI [4,3]
C0393022
UMLS CUI [5,1]
C0012634
UMLS CUI [5,2]
C0332325
UMLS CUI [5,3]
C0687676
UMLS CUI [5,4]
C0393022
no 17p deletion
Descripción

Exclusion Loss of Chromosome 17p

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2828389
UMLS CUI [1,2]
C1517965
patient characteristics:
Descripción

Client Characteristics

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0815172
who performance status 0-2
Descripción

WHO performance status scale

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1298650
life expectancy > 1 year
Descripción

Life Expectancy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023671
creatinine clearance ≥ 50 ml/min
Descripción

Creatinine clearance measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0373595
hiv negative
Descripción

HIV negative

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0481430
not pregnant or nursing
Descripción

Pregnancy Absent | Breast Feeding Absent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0006147
UMLS CUI [2,2]
C0332197
negative pregnancy test
Descripción

Pregnancy test negative

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0427780
fertile patients must use effective contraception
Descripción

Fertility Contraceptive methods

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0015895
UMLS CUI [1,2]
C0700589
no other concurrent malignancy except for noninvasive cervical cancer or localized nonmelanomatous skin cancer
Descripción

Exclusion Cancer Other | Exception Cervical cancer Noninvasive | Exception Skin carcinoma Localized

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2828389
UMLS CUI [1,2]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C4048328
UMLS CUI [2,3]
C2986496
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0699893
UMLS CUI [3,3]
C0392752
no history of anaphylaxis to mouse-derived humanized monoclonal antibody
Descripción

Exclusion Anaphylaxis Murine-Derived Monoclonal Antibodies Humanized

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2828389
UMLS CUI [1,2]
C0002792
UMLS CUI [1,3]
C2916903
UMLS CUI [1,4]
C2985546
no other severe concurrent (e.g., cardiac or pulmonary) diseases or mental disorders that could interfere with ability to participate in the study
Descripción

Exclusion Criteria | Comorbidity Severe | Heart Diseases | Lung diseases | Mental disorders Interfere with Study Subject Participation Status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C0205082
UMLS CUI [3]
C0018799
UMLS CUI [4]
C0024115
UMLS CUI [5,1]
C0004936
UMLS CUI [5,2]
C0521102
UMLS CUI [5,3]
C2348568
prior concurrent therapy:
Descripción

Therapeutic procedure

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0087111
see disease characteristics
Descripción

ID.18

Tipo de datos

boolean

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Similar models

Eligibility Leukemia NCT00812669

1 formularios
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00812669
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
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])
Cell positive for CD5 antigen | Cell positive for CD23 antigen
Item
cd5 and cd23 positive
boolean
C0882892 (UMLS CUI [1])
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])
Exclusion Loss of Chromosome 17p
Item
no 17p deletion
boolean
C2828389 (UMLS CUI [1,1])
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])
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])
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])
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])
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])
Therapeutic procedure
Item
prior concurrent therapy:
boolean
C0087111 (UMLS CUI [1])
ID.18
Item
see disease characteristics
boolean
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