NCT03233074

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
93

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2017

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 17, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 28, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

November 17, 2017

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 19, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 19, 2022

Completed
Last Updated

May 6, 2023

Status Verified

May 1, 2023

Enrollment Period

4.4 years

First QC Date

July 17, 2017

Last Update Submit

May 4, 2023

Conditions

Myelodysplastic SyndromesAcute Myeloid LeukemiaCardio-vascular Surgery

Keywords

Myelodysplastic SyndromesAcute Myeloid LeukemiaBone MarrowMesenchymal stromal cellHealthy donor

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Number of differential biomarkers in mesenchymal stromal cells

    Day 0

Study Arms (2)

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

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

Interventions

Bone marrow analysesOTHER

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.

Also known as: Cellular properties of mesenchymal stromal cells
Acute Myeloid Leukemia patientsHealthy donors

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHU de Saint-Etienne

Saint-Etienne, 42055, France

Location

CHU de Saint-Etienne

Saint-Priest-en-Jarez, 42270, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

Bone marrow

MeSH Terms

Conditions

Myelodysplastic SyndromesLeukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Bone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasms

Study Officials

  • Denis Guyotat, PhD

    CHU de Saint-Etienne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2017

First Posted

July 28, 2017

Study Start

November 17, 2017

Primary Completion

April 19, 2022

Study Completion

April 19, 2022

Last Updated

May 6, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)