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

Not Applicable

• Conditions: Acute Leukemia; Myelodysplastic Syndromes; Myeloproliferative Disorders

• Registration Number: NCT02320656
• Lead Sponsor: Institut Paoli-Calmettes

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-12-05
• Study First Submitted QC: 2014-12-16
• Study First Posted: 2014-12-19
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-24
• Last Update Posted: 2018-07-26
• Primary Completion: 2019-05
• Study Completion: 2024-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 650

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Acute leukemia/ Myeloproliferative/ myelodysplastic syndrome cells profiling (molecular analysis, epigenetic profile, drug sensitivity profile,immunophenotyping)	up to 8 years

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Institut Paoli-Calmettes; 🇫🇷 Marseille, France