Clinical trial NCT03233074: Constitution of a Biological Cohort Following Bone Marrow Sampling From MDS or AML Patients and Age-matched Healthy Donors
Official title: Constitution of a Biological Cohort Following Bone Marrow Sampling From MDS or AML Patients and Age-matched Healthy Donors (COSMOS)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Myelodysplastic Syndromes
Acute Myeloid Leukemia
Cardio-vascular Surgery
Keywords: Myelodysplastic Syndromes
Acute Myeloid Leukemia
Bone Marrow
Mesenchymal stromal cell
Healthy donor
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
Collaborators: name: Institut de Cancérologie de la Loire
First posted: 2017-07-28
Enrollment: 93
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Acute Myeloid Leukemia patients undergoing a bone marrow sampling for diagnosis purposes, and healthy donors undergoing cardio-vascular surgery for their usual support.

Brief summary: It is of clinical significance to better characterize the intrinsic defects harbored by mesenchymal stromal cells (MSC) in Myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML) context, as compared to physiological conditions. Such research initiative aims to dissect the cross-talk between malignant hematopoietic stem cells (HSC) and their bone marrow (BM) partners in crime, further prospecting for innovative stromal-directed strategies for the treatment of Myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML).

Detailed description: Myelodysplastic syndromes (MDS) are a heterogeneous group of clonal malignancies that are characterized by ineffective hematopoiesis, progressive bone marrow failure, cytogenetic and molecular abnormalities, and increased risk for progression to acute myeloid leukemia (AML). It is a well-accepted theory that MDS and AML originate from primary alterations of hematopoietic stem cells (HSC) compartment, which confer a survival advantage to them at the expense of physiological hematopoiesis. More recently, there is growing evidences regarding the contribution of the bone marrow (BM) microenvironment to the pathogenesis of MDS and AML. Of particular interest, several studies have pointed towards a pivotal role of mesenchymal stromal cells (MSC), one of the main components of the BM niche, in the initiation and propagation of myeloid disorders. In this context, it is of clinical significance to better characterize the intrinsic defects harbored by MSC in MDS and AML context, as compared to physiological conditions. Such research initiative aims to dissect the cross-talk between malignant HSC and their BM partners in crime, further prospecting for innovative stromal-directed strategies for the treatment of MDS and AML.

Eligibility criteria: Inclusion Criteria:

* Patients with diagnosed myelodysplasia or acute myeloid leukemia (study place: ICLN) - Specific to the cases cohort
* Age-matched healthy donors undergoing a cardiovascular surgery - Specific to the control cohort
* Signed written informed consent form
* Patient affiliated to a social security regimen or beneficiary of the same

Exclusion Criteria:

* Medical history of hematological disorders
* Thrombocytopenia, anemia...
* Patient under guardianship or deprived of his liberty or any condition that may affect the patient's ability to understand and sign the informed consent (art. L.1121-6, L.112-7, L.1211-8, L.1211-9)
* Pregnant or breastfeeding women
* Refusing participation

Primary outcomes:
measure: Changes in cellular properties of mesenchymal stromal cells
timeFrame: Day 0
Secondary outcomes:
measure: Number of differential biomarkers in mesenchymal stromal cells
timeFrame: Day 0
Other outcomes:
Locations:
city: Saint-Priest-en-Jarez
country: France
facility: CHU de Saint-Etienne
city: Saint-Étienne
country: France
facility: CHU de Saint-Etienne
Study officials:
affiliation: CHU de Saint-Etienne
name: Denis Guyotat, PhD
role: PRINCIPAL_INVESTIGATOR
References: