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

Institut Paoli-Calmettes

Status: Unknown

Conditions: Acute Leukemia; Myeloproliferative Disorders; Myelodysplastic Syndromes

Treatments: Other: Bone marrow aspirate; Other: Skin biopsy; Other: Blood sampling; Other: Buccal swab

Study type: Interventional

Funder types: Other

Identifiers

NCT02320656

HEMATO-BIO-IPC-2013-015

Details and patient eligibility

About

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.

Enrollment: 650 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

650 participants in 1 patient group

Acute leukemia/myelodysplastic or myeloproliferative disease

Experimental group

Treatment:

Other: Blood sampling

Other: Bone marrow aspirate

Other: Buccal swab

Other: Skin biopsy