Chronic Lymphoid Leukaemia Observatory in Finistere Area, France (OFICE)

January 27, 2021 updated by: University Hospital, Brest

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patient with Chronic Lymphoid Leukaemia

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence
Time Frame: Year 0 (Y)
Clinical data
Year 0 (Y)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence
Time Frame: Year 0
Clinical and biological data
Year 0
Description of baseline clinical-biological
Time Frame: 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
Year 0, Year 1, Year 2, Year 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Brest

Investigators

  • Study Director: Yves Reanudineau, CHRU de Brest

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Anticipated)

November 1, 2025

Study Completion (Anticipated)

November 1, 2025

Study Registration Dates

First Submitted

August 26, 2016

First Submitted That Met QC Criteria

September 22, 2017

First Posted (Actual)

September 27, 2017

Study Record Updates

Last Update Posted (Actual)

January 28, 2021

Last Update Submitted That Met QC Criteria

January 27, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OFICE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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