Predictive Clinical and Biological Parameters in Acute Leukemia, Myelodysplastic Syndromes and Myeloproliferative Disorders-HEMATO-BIO-IPC-2013-015

Study Overview
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Brief Summary
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HEMATO-BIO-IPC-2013-015 is a monocenter prospective longitudinal study. Our aim is to define predictive clinical and biological factors in acute leukemia, myelodysplastic syndromes and myeloproliferative disorders by using genomics, genetics and epigenetics, in vitro and in vivo drug sensitivity studies,and translational immonulogy and immunomonitoring studies. HEMATO-BIO primary outcome measure is to identify molecular, genomic and epigenetic, pharmacologic and immunophenotypic alteration in acute leukemia, myelodysplastic syndromes and myeloproliferative disorders by collecting, at diagnosis and/or complete remission and/or relapse: tumor samples: marrow aspiration, blood sampling. non-tumor samples: skin biopsy, buccal swab . from 650 patients treated at our cancer center.

Official Title
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Predictive Clinical and Biological Parameters in Acute Leukemia, Myelodysplastic Syndromes and Myeloproliferative Disorders-HEMATO-BIO-IPC-2013-015

Conditions
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Acute Leukemia, Myelodysplastic Syndromes, Myeloproliferative Disorders

Intervention / Treatment
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* Other: Blood sampling
* Other: Bone marrow aspirate
* Other: Skin biopsy
* Other: Buccal swab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: acute leukemia, myelodysplastic syndrome or myeloproliferative disease age > 18 affiliated to the French Social Security Systm signed informed consent Exclusion Criteria: emergency patients deprived of liberty or placed under the authority of a tutor

Ages Eligible for Study
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Minimum Age: 18 Years

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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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acute leukemia/myelodysplastic or myeloproliferative disease<br> | Other: Blood sampling<br>* Longitudinal (3 stages of the disease)<br>Other: Bone marrow aspirate<br>* Longitudinal (3 stages of the disease)<br>Other: Skin biopsy<br>* Single biopsy (optional)<br>Other: Buccal swab<br>* Single sampling.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute leukemia/ Myeloproliferative/ myelodysplastic syndrome cells profiling (molecular analysis, epigenetic profile, drug sensitivity profile,immunophenotyping) |  | up to 8 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between molecular alteration and clinical characteristics(diagnosis,cytogenetics,overall survival, progression free survival) |  | up to 8 years | 
| Compare cancer and non-tumor cells genome |  | up to 8 years |