Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03294980
Other study ID # OFICE
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 2015
Est. completion date November 2025

Study information

Verified date January 2021
Source University Hospital, Brest
Contact Yves Renaudineau
Email yves.renaudineau@chu-brest.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 3000
Est. completion date November 2025
Est. primary completion date November 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Locations

Country Name City State
France CHRU de Brest Brest

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Prevalence Clinical data Year 0 (Y)
Secondary Incidence Clinical and biological data Year 0
Secondary Description of baseline clinical-biological Clinical data, complete blood count, Matutes score and parameters, cytogenetic, IgVH mutations, CD38 (%), medical treatment will be collected Year 0, Year 1, Year 2, Year 3