Regional Central Database Recording of Chronic Myeloid Leukemia (LMC)

November 17, 2017 updated by: Institut Bergonié
It will be a centralized database , multicentre (6 centers) , regional, chronic myelogenous leukemia cases of registration (CML) prospectively and retrospectively.

Study Overview

Status

Recruiting

Intervention / Treatment

Detailed Description

Given the complexity and evolution of recommendations and to harmonize these, it appears necessary to establish a central database for recording , monitoring patients with CML supported by the participating centers the region and evaluation of care practices in use .

Indeed , the main purpose of this database is to provide diagnostic and therapeutic management of reported cases of chronic myeloid leukemia and to study the prognostic factors . The main objective is to improve significantly the percentage of patients treated adequately load in the region, in the initial stages of the disease and during its evolution.

Study Type

Observational

Enrollment (Anticipated)

400

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 Contact Backup

Study Locations

      • Bordeaux, France
        • Recruiting
        • Institut Bergonie
        • Contact:
          • Gabriel Etienne
      • Bordeaux, France, 33076
        • Recruiting
        • Centre Hospitalier Universitaire De Bordeaux
        • Contact:
          • François Xavier Mahon, MD PhD
      • Bordeaux, France, 33000
        • Recruiting
        • Polyclinique Bordeaux Nord
        • Contact:
          • Olivier FITOUSSI
      • Dax, France, 40100
        • Recruiting
        • Centre Hospitalier Universitaire de Dax
        • Contact:
          • François LIFERMANN
      • Libourne, France
        • Recruiting
        • Centre hospitalier Libourne
        • Contact:
          • Joël CECCALDI
      • Pau, France, 64000
        • Recruiting
        • Centre Hospitalier Universitaire de Pau
        • Contact:
          • Corinne Dagada

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

Non-Probability Sample

Study Population

Patient with chronic myeloid leukemia diagnosis in chronic phase

Description

Inclusion Criteria:

  • chronic myeloid leukemia Diagnosis (CML) in chronic phase , accelerated or blast
  • male or female patient aged 18 years or more
  • Cases transmitted by referring hematologist , one of the 6 participating centers after patient's oral information
  • Clinical record presented Concertation Meeting LMC Multidisciplinary coordinated by the Institute Bergonié

Exclusion Criteria:

  • none

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
Time Frame
compliance of the management of patients with chronic myeloid leukemia compared to the guidelines
Time Frame: 10 years
10 years

Secondary Outcome Measures

Outcome Measure
Time Frame
overall survival
Time Frame: 10 years
10 years

Collaborators and Investigators

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

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

January 1, 2014

Primary Completion (Anticipated)

January 1, 2024

Study Completion (Anticipated)

January 1, 2024

Study Registration Dates

First Submitted

August 9, 2016

First Submitted That Met QC Criteria

August 11, 2016

First Posted (Estimate)

August 16, 2016

Study Record Updates

Last Update Posted (Actual)

November 21, 2017

Last Update Submitted That Met QC Criteria

November 17, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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