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

NCT ID: NCT03233074

Last Updated: 2023-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

93 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-17

Study Completion Date

2022-04-19

Brief Summary

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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

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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.

Conditions

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Myelodysplastic Syndromes Acute Myeloid Leukemia Cardio-vascular Surgery

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Bone marrow analyses

Intervention Type OTHER

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.

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.

Bone marrow analyses

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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Cellular properties of mesenchymal stromal cells

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Institut de Cancérologie de la Loire

OTHER

Sponsor Role collaborator

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Denis Guyotat, PhD

Role: PRINCIPAL_INVESTIGATOR

CHU de Saint-Etienne

Locations

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CHU de Saint-Etienne

Saint-Etienne, , France

Site Status

CHU de Saint-Etienne

Saint-Priest-en-Jarez, , France

Site Status

Countries

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France

Other Identifiers

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2017-A02088-45

Identifier Type: OTHER

Identifier Source: secondary_id

2017-0701

Identifier Type: -

Identifier Source: org_study_id

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