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Completed

NCT Number: NCT02320656

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

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.

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Key information

Conditions

Acute Leukemia Bone Marrow Diseases Hematologic Diseases Hemic and Lymphatic Diseases Myelodysplastic Syndromes Myeloproliferative Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut Paoli-Calmettes

Marseille, 13009, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood sampling

Other

Longitudinal (3 stages of the disease)

Bone marrow aspirate

Other

Longitudinal (3 stages of the disease)

Skin biopsy

Other

Single biopsy (optional)

Buccal Swab

Other

Single sampling.

Primary outcomes

  1. Acute leukemia/ Myeloproliferative/ myelodysplastic syndrome cells profiling (molecular analysis, epigenetic profile, drug sensitivity profile,immunophenotyping)

    Time frame: up to 8 years

Secondary outcomes

  1. Correlation between molecular alteration and clinical characteristics(diagnosis,cytogenetics,overall survival, progression free survival)

    Time frame: up to 8 years

  2. Compare cancer and non-tumor cells genome

    Time frame: up to 8 years

Sponsors and collaborators

Lead sponsor

Institut Paoli-Calmettes

Other

Registry information

Acronym: HEMATO-BIO

Important dates

Study start
2014
Primary completion
2024
Study completion
2024
First posted
Dec 19, 2014
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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