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OFICE: Chronic Lymphoid Leukaemia Observatory in Finistere Area, France

Sponsor
University Hospital, Brest (Other)
Overall Status
Recruiting
CT.gov ID
NCT03294980
Collaborator
(none)
3,000
Enrollment
1
Location
120
Duration (Months)
25
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    3000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Study Start Date :
    Nov 1, 2015
    Anticipated Primary Completion Date :
    Nov 1, 2025
    Anticipated Study Completion Date :
    Nov 1, 2025

    Outcome Measures

    Primary Outcome Measures

    1. Prevalence [Year 0 (Y)]

      Clinical data

    Secondary Outcome Measures

    1. Incidence [Year 0]

      Clinical and biological data

    2. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHRU de Brest Brest France 29609

    Sponsors and Collaborators

    • University Hospital, Brest

    Investigators

    • Study Director: Yves Reanudineau, CHRU de Brest

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Brest
    ClinicalTrials.gov Identifier:
    NCT03294980
    Other Study ID Numbers:
    • OFICE
    First Posted:
    Sep 27, 2017
    Last Update Posted:
    Jan 28, 2021
    Last Verified:
    Jan 1, 2021
    Keywords provided by University Hospital, Brest
    Chronic lymphocytic leukemia
    Observational study
    Additional relevant MeSH terms:
    Leukemia
    Leukemia, Lymphoid
    Leukemia, Lymphocytic, Chronic, B-Cell

    Study Results

    No Results Posted as of Jan 28, 2021