ID

28075

Descrição

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

Palavras-chave

Versões (1)
  1. 15/12/2017 15/12/2017 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

15 de dezembro de 2017

DOI

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Licença

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

Inglês

Eligibility Chronic Lymphocytic Leukemia Stage A(0) NCT00917540

1 Formulários  
Inclusion Criteria
Descrição

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)).
Descrição

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

Tipo de dados

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.
Descrição

Age

Tipo de dados

boolean

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

ECOG performance status

Tipo de dados

boolean

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

Binet Staging System

Tipo de dados

boolean

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

Diagnosis Performed Recently

Tipo de dados

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).
Descrição

Therapeutic procedure Redundant

Tipo de dados

boolean

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

Peripheral blood specimen Assessment biological

Tipo de dados

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.
Descrição

Clinical Data Available | Staging | Compliance behavior Follow-up

Tipo de dados

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.
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrição

Exclusion Criteria

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

CLL Prior diagnosis

Tipo de dados

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.
Descrição

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

Tipo de dados

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.
Descrição

Binet Staging System

Tipo de dados

boolean

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

Therapeutic procedure Patient need for

Tipo de dados

boolean

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

Age

Tipo de dados

boolean

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

Informed Consent Lacking

Tipo de dados

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 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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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