Constitution of a Biological Cohort Following Bone Marrow Sampling From MDS or AML Patients and Age-matched Healthy Donors (COSMOS)

Constitution of a Biological Cohort Following Bone Marrow Sampling From MDS or AML Patients and Age-matched Healthy Donors (COSMOS)

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).

Study Overview

• Status: Terminated
• Conditions: Acute Myeloid Leukemia; Myelodysplastic Syndromes; Cardio-vascular Surgery
• Intervention / Treatment: Other: Bone marrow analyses

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.

• Study Type: Observational
• Enrollment (Actual): 93

Contacts and Locations

• Study Contact: Name: Denis Guyotat, PhD; Phone Number: +33 (0)4 77 91 70 70; Email: denis.guyotat@chu-st-etienne.fr
• Study Contact Backup: Name: Elisabeth Daguenet, PhD; Phone Number: +33 (0)4 77 91 70 89; Email: Elisabeth.daguenet@chu-st-etienne.fr

Study Locations

• France
  • Saint-Priest-en-Jarez, France, 42270
    • CHU de Saint-Etienne
  • Saint-Étienne, France, 42055
    • CHU de Saint-Etienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Acute Myeloid Leukemia patients; For diagnosis purpose, bone marrow sampling is performed for acute myeloid leukemia patients. 2 milliliters of this sample will be collected and analysed for the COSMOS study.	Other: Bone marrow analyses; This is a non-interventional study for the constitution of a biobank of bone marrows, in order to further investigate in vitro the cellular properties of bone marrow-isolated mesenchymal stromal cells.; Other Names: Cellular properties of mesenchymal stromal cells
Healthy donors; Healthy donors are patients undergoing cardio-vascular surgery for their usual support. During this surgery, 2 milliliters of the bone marrow will be collected, and analysed for the COSMOS study.	Other: Bone marrow analyses; This is a non-interventional study for the constitution of a biobank of bone marrows, in order to further investigate in vitro the cellular properties of bone marrow-isolated mesenchymal stromal cells.; Other Names: Cellular properties of mesenchymal stromal cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in cellular properties of mesenchymal stromal cells	Changes in cellular properties of mesenchymal stromal cells isolated from bone marrow aspirates by comparing normal cells (i.e. healthy donors) and MDS/AML cells.	Day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of differential biomarkers in mesenchymal stromal cells	Number of differential biomarkers expressed by MDS or AML-derived mesenchymal stromal cells	Day 0

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Collaborators: Institut de Cancérologie de la Loire

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2017
• Primary Completion (Actual): April 19, 2022
• Study Completion (Actual): April 19, 2022

Study Registration Dates

• First Submitted: July 17, 2017
• First Submitted That Met QC Criteria: July 25, 2017
• First Posted (Actual): July 28, 2017

Study Record Updates

• Last Update Posted (Estimate): May 5, 2023
• Last Update Submitted That Met QC Criteria: May 4, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Acute Myeloid Leukemia; Myelodysplastic Syndromes; Bone Marrow; Mesenchymal stromal cell; Healthy donor
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Bone Marrow Diseases; Hematologic Diseases; Precancerous Conditions; Leukemia; Myelodysplastic Syndromes; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Preleukemia
• Other Study ID Numbers: 2017-0701; 2017-A02088-45 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No