ID

28075

Description

Prospective Collection of Biological Data of Prognostic Relevance in Patients With B-Cell Chronic Lymphocytic Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT00917540

Link

https://clinicaltrials.gov/show/NCT00917540

Keywords

Versions (1)
  1. 12/15/17 12/15/17 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

December 15, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Chronic Lymphocytic Leukemia Stage A(0) NCT00917540

English

Eligibility Chronic Lymphocytic Leukemia Stage A(0) NCT00917540

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
established diagnosis of b-cll by nci criteria, performed by local haematologist. (diagnosis will be confirmed by the biological review committee according to flow cytometry analysis (positive clusters of differentiation antigen 5 (cd5), 19 (cd19),23 (cd23)).
Description

Chronic Lymphocytic Leukemia | Flow Cytometry CD5 positive | Flow Cytometry CD19 positive | Flow Cytometry CD23 positive

Data type

boolean

Alias
UMLS CUI [1]
C0023434
UMLS CUI [2,1]
C0016263
UMLS CUI [2,2]
C0882892
UMLS CUI [3,1]
C0016263
UMLS CUI [3,2]
C0882808
UMLS CUI [4,1]
C0016263
UMLS CUI [4,2]
C0945924
age > 18 years and < 70 years.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
eastern cooperative oncology group (ecog)<=2.
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
binet stage a.
Description

Binet Staging System

Data type

boolean

Alias
UMLS CUI [1]
C1511118
diagnosis performed within 12 months before inclusion in the study.
Description

Diagnosis Performed Recently

Data type

boolean

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C0884358
UMLS CUI [1,3]
C0332185
patients who do not necessitate therapy by nci guidelines (watch and wait policy).
Description

Therapeutic procedure Redundant

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C1313915
shipment of peripheral blood sample to centralized laboratory for biological assessment.
Description

Peripheral blood specimen Assessment biological

Data type

boolean

Alias
UMLS CUI [1,1]
C1292451
UMLS CUI [1,2]
C1516048
UMLS CUI [1,3]
C0205460
clinical data including baseline information on disease localization and laboratory parameters at staging and assurance of follow up updating for at least 3 years are requested.
Description

Clinical Data Available | Staging | Compliance behavior Follow-up

Data type

boolean

Alias
UMLS CUI [1,1]
C1516606
UMLS CUI [1,2]
C0470187
UMLS CUI [2]
C0332305
UMLS CUI [3,1]
C1321605
UMLS CUI [3,2]
C3274571
written informed consent.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with cll whose diagnosis exceed 12 months before registration.
Description

CLL Prior diagnosis

Data type

boolean

Alias
UMLS CUI [1,1]
C0023434
UMLS CUI [1,2]
C0332132
patients with leukemic phase of lymphoproliferative disorders of b origin cd5- and/or cd23- according to flow cytometry analysis.
Description

Lymphoproliferative Disorders B-Cell | Leukemia Phase | Flow Cytometry CD5 | Flow Cytometry CD23

Data type

boolean

Alias
UMLS CUI [1,1]
C0024314
UMLS CUI [1,2]
C0004561
UMLS CUI [2,1]
C0023418
UMLS CUI [2,2]
C0205390
UMLS CUI [3,1]
C0016263
UMLS CUI [3,2]
C0054964
UMLS CUI [4,1]
C0016263
UMLS CUI [4,2]
C0123242
clinical binet stage b or c.
Description

Binet Staging System

Data type

boolean

Alias
UMLS CUI [1]
C1511118
patients who necessitate therapy according to nci guide-lines (no watch and wait policy).
Description

Therapeutic procedure Patient need for

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0686904
age > 70 years.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
without a written informed consent.
Description

Informed Consent Lacking

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0332268
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Similar models

Eligibility Chronic Lymphocytic Leukemia Stage A(0) NCT00917540

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Chronic Lymphocytic Leukemia | Flow Cytometry CD5 positive | Flow Cytometry CD19 positive | Flow Cytometry CD23 positive
Item
established diagnosis of b-cll by nci criteria, performed by local haematologist. (diagnosis will be confirmed by the biological review committee according to flow cytometry analysis (positive clusters of differentiation antigen 5 (cd5), 19 (cd19),23 (cd23)).
boolean
C0023434 (UMLS CUI [1])
C0016263 (UMLS CUI [2,1])
C0882892 (UMLS CUI [2,2])
C0016263 (UMLS CUI [3,1])
C0882808 (UMLS CUI [3,2])
C0016263 (UMLS CUI [4,1])
C0945924 (UMLS CUI [4,2])
Age
Item
age > 18 years and < 70 years.
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
eastern cooperative oncology group (ecog)<=2.
boolean
C1520224 (UMLS CUI [1])
Binet Staging System
Item
binet stage a.
boolean
C1511118 (UMLS CUI [1])
Diagnosis Performed Recently
Item
diagnosis performed within 12 months before inclusion in the study.
boolean
C0011900 (UMLS CUI [1,1])
C0884358 (UMLS CUI [1,2])
C0332185 (UMLS CUI [1,3])
Therapeutic procedure Redundant
Item
patients who do not necessitate therapy by nci guidelines (watch and wait policy).
boolean
C0087111 (UMLS CUI [1,1])
C1313915 (UMLS CUI [1,2])
Peripheral blood specimen Assessment biological
Item
shipment of peripheral blood sample to centralized laboratory for biological assessment.
boolean
C1292451 (UMLS CUI [1,1])
C1516048 (UMLS CUI [1,2])
C0205460 (UMLS CUI [1,3])
Clinical Data Available | Staging | Compliance behavior Follow-up
Item
clinical data including baseline information on disease localization and laboratory parameters at staging and assurance of follow up updating for at least 3 years are requested.
boolean
C1516606 (UMLS CUI [1,1])
C0470187 (UMLS CUI [1,2])
C0332305 (UMLS CUI [2])
C1321605 (UMLS CUI [3,1])
C3274571 (UMLS CUI [3,2])
Informed Consent
Item
written informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
CLL Prior diagnosis
Item
patients with cll whose diagnosis exceed 12 months before registration.
boolean
C0023434 (UMLS CUI [1,1])
C0332132 (UMLS CUI [1,2])
Lymphoproliferative Disorders B-Cell | Leukemia Phase | Flow Cytometry CD5 | Flow Cytometry CD23
Item
patients with leukemic phase of lymphoproliferative disorders of b origin cd5- and/or cd23- according to flow cytometry analysis.
boolean
C0024314 (UMLS CUI [1,1])
C0004561 (UMLS CUI [1,2])
C0023418 (UMLS CUI [2,1])
C0205390 (UMLS CUI [2,2])
C0016263 (UMLS CUI [3,1])
C0054964 (UMLS CUI [3,2])
C0016263 (UMLS CUI [4,1])
C0123242 (UMLS CUI [4,2])
Binet Staging System
Item
clinical binet stage b or c.
boolean
C1511118 (UMLS CUI [1])
Therapeutic procedure Patient need for
Item
patients who necessitate therapy according to nci guide-lines (no watch and wait policy).
boolean
C0087111 (UMLS CUI [1,1])
C0686904 (UMLS CUI [1,2])
Age
Item
age > 70 years.
boolean
C0001779 (UMLS CUI [1])
Informed Consent Lacking
Item
without a written informed consent.
boolean
C0021430 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])
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