Chronic Lymphoid Leukaemia Observatory in Finistere Area, France

Recruiting

• Conditions: Chronic Lymphoid Leukaemia

• Registration Number: NCT03294980
• Lead Sponsor: University Hospital, Brest

Brief Summary

Brief Summary: The purpose of the OFICE registry is to characterize and describe the CLL patients' population from the Finistere area and evaluates the association between different patient characteristics, prognosis and treatment patterns.

Detailed Description: OFICE is a single center, prospective, observational registry of CLL patients designed to provide a general description of the CLL patients' population from the Finistere area, France. The registry will also provide information on the association of cytogenetic and immunophenotypic characteristics with disease progression, as well as treatment patterns and healthcare resource utilization. These data will be accessible and beneficial for researchers and physicians and will help guide clinical practice and future clinical or fundamental studies.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2016-08-26
• Study First Submitted QC: 2017-09-22
• Study First Posted: 2017-09-27
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-27
• Last Update Posted: 2021-01-28
• Primary Completion: 2025-11
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3000

Inclusion Criteria

• Age of at least 18 years
• Clinical diagnosis of CLL/SLL that meets published diagnostic criteria (Hallek 2008)
• Willing and able to provide informed consent
• Willing and able to provide blood sample at time of enrollment

Exclusion Criteria

• Diagnosis of other B-cell malignancies

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence	Year 0 (Y)	Clinical data

Secondary Outcome Measures

Name	Time	Method
Description of baseline clinical-biological	Year 0, Year 1, Year 2, Year 3	Clinical data, complete blood count, Matutes score and parameters, cytogenetic, IgVH mutations, CD38 (%), medical treatment will be collected
Incidence	Year 0	Clinical and biological data

Trial Locations

Locations (1)

CHRU de Brest; 🇫🇷 Brest, France