Chronic Myeloid Leukemia (CML) Real-Life Database

Study Overview
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Brief Summary
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Establish the largest possible real-life cohort collecting long-term follow-up of a maximum number of CML patients in order to carry out observational studies: epidemiological, identification of subgroups according to their response to treatment, evaluation of new molecules in real life, therapeutic discontinuations, impact of the evolution of recommendations, etc.

Detailed Description
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Observational study collecting real-life clinico-biological data from patients with CML. Data are collected prospectively and retrospectively, from diagnosis and throughout the long-term follow-up of CML (follow up continues after treatment stopped).

Official Title
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Chronic Myeloid Leukemia (CML) Real-Life Database

Conditions
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Chronic Myeloid Leukemia (CML)

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient diagnosed for chronic myelocytic leukemia Exclusion Criteria: CML allograft without TKI treatment Refusal or inability to sign the consent
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical and biological data collection | Aims of the registry are the collection of clinical data to gain further insights about patients's CML treated with ITK's (treatment, prognosis, therapeutical response). | Until death or last follow up (up to 30 years) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prognosis score for CML (Sokal, ELTS, Eutos, Hasford) |  | At diagnosis | 
| BMI with evaluation of weight and height |  | Until death or last follow up (up to 30 years) | 
| Evaluation of major molecular response (MMR) with transcript BCR::ABL in % |  | Until death or last follow up (up to 30 years) | 
| Evaluation of molecular response MR4 with transcript BCR::ABL in % |  | Until death or last follow up (up to 30 years) | 
| Evaluation of molecular response MR4.5 with transcript BCR::ABL in % |  | Until death or last follow up (up to 30 years) | 
| Evaluation of molecular response MR5 with transcript BCR::ABL in % |  | Until death or last follow up (up to 30 years) | 
| Evaluation of cytogenetic response |  | Until death or last follow up (up to 30 years) | 
| Evaluation of TKI efficacy based on transcript BCR::ABL in % |  | Until death or last follow up (up to 30 years) | 
| Evaluation of TKI tolerance (adverses events) |  | Until death or last follow up (up to 30 years) | 
| Calcul in month of the duration of maintenance TFR (treatment free remission) after stop TKI for thérapeutic response |  | Until death or last follow up (up to 30 years) | 
| Listing of major medical history of patient's CML |  | Until death or last follow up (up to 30 years) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Leukemia, Leukemia, Myeloid, Chronic myeloid leukemia, Chronic, BCR::ABL Positive, Hematologic Malignancies, Tyrosine kinase inhibitor (TKI), Targeted therapy