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Regional Central Database Recording of Chronic Myeloid Leukemia (LMC)

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ClinicalTrials.gov Identifier: NCT02869256
Recruitment Status : Recruiting
First Posted : August 16, 2016
Last Update Posted : November 21, 2017
Sponsor:
Information provided by (Responsible Party):
Institut Bergonié

Brief Summary:
It will be a centralized database , multicentre (6 centers) , regional, chronic myelogenous leukemia cases of registration (CML) prospectively and retrospectively.

Condition or disease Intervention/treatment
Chronic Myeloid Leukemia Other: Practices evaluation

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.


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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Regional Central Database Recording of Chronic Myeloid Leukemia
Study Start Date : January 2014
Estimated Primary Completion Date : January 2024
Estimated Study Completion Date : January 2024



Intervention Details:
  • Other: Practices evaluation
    Practices evaluation


Primary Outcome Measures :
  1. compliance of the management of patients with chronic myeloid leukemia compared to the guidelines [ Time Frame: 10 years ]

Secondary Outcome Measures :
  1. overall survival [ Time Frame: 10 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient with chronic myeloid leukemia diagnosis in chronic phase
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02869256


Contacts
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Contact: Gabriel etienne, MD G.Etienne@bordeaux.unicancer.fr
Contact: Simone Mathoulin-Pelissier, MD PhD S.Mathoulin@bordeaux.unicancer.fr

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

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Responsible Party: Institut Bergonié
ClinicalTrials.gov Identifier: NCT02869256     History of Changes
Other Study ID Numbers: IB2014-LMC
First Posted: August 16, 2016    Key Record Dates
Last Update Posted: November 21, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Institut Bergonié:
chronic myeloid leukemia
practices evaluation

Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases