Myelodysplastic SyndromesCOSMOSNCT03233074
Constitution of a Biological Cohort Following Bone Marrow Sampling From MDS or AML Patients and Age-matched Healthy Donors
An observational study of Myelodysplastic Syndromes and Acute Myeloid Leukemia, run by Centre Hospitalier Universitaire de Saint Etienne at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Myelodysplastic Syndromes, Acute Myeloid Leukemia, Cardio-vascular Surgery
- What is being tested?
- Bone marrow analyses
- How many people
- 93 participants
- Where
- 2 sitesFrance
- Study dates
- 17 Nov 2017to 19 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHU de Saint-Etienne
Saint-Etienne, 42055
CHU de Saint-Etienne
Saint-Priest-en-Jarez, 42270
About this study
Official title: 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).
Read the 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.
- Being tested
- Bone marrow analyses
- Keywords
- Myelodysplastic Syndromes, Acute Myeloid Leukemia, Bone Marrow, Mesenchymal stromal cell, Healthy donor
- Medical subject headings
- Myelodysplastic Syndromes, Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone marrow analysesOther
Also called Cellular properties of mesenchymal stromal cells
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Bone marrow analyses |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 0
Secondary outcomes (1)
Number of differential biomarkers in mesenchymal stromal cells
Number of differential biomarkers expressed by MDS or AML-derived mesenchymal stromal cells
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2017
- Study start17 Nov 2017
- Primary completion19 Apr 2022
- Study completion19 Apr 2022
Why it stopped: Achievement of scientific objectives
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myelodysplastic SyndromesStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Institut de Cancérologie de la Loire
- Responsible party
- Sponsor
- Investigators
- Denis Guyotat, PhD, Principal investigator, CHU de Saint-Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03233074
- Sponsor's protocol ID
- 2017-0701
- Other IDs
- 2017-A02088-45
- Acronym
- COSMOS
- Status last verified
- May 2023
- First submitted
- 17 Jul 2017
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Constitution of a Biological Cohort Following Bone Marrow Sampling From MDS or AML Patients and Age-matched Healthy Donors (COSMOS)
- ClinicalTrials.gov ID
- NCT03233074
- Acronym / sponsor ID
- COSMOS / 2017-0701
- Keywords
- Myelodysplastic Syndromes, Acute Myeloid Leukemia, Bone Marrow, Mesenchymal stromal cell, Healthy donor
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Achievement of scientific objectives
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Collaborators
- Institut de Cancérologie de la Loire
- Study start
- 17 Nov 2017 (actual)
- Primary completion
- 19 Apr 2022 (actual)
- Study completion
- 19 Apr 2022 (actual)
- First posted
- 28 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acute Myeloid Leukemia patients | – | Other: Bone marrow analysesFor 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. |
| Healthy donors | – | Other: Bone marrow analysesHealthy 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. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bone marrow analysesAlso: Cellular properties of mesenchymal stromal cellsThis 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 | Acute Myeloid Leukemia patients, Healthy donors |
Primary outcome
Changes in cellular properties of mesenchymal stromal cells
Time frame: Day 0
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.
1 secondary outcome
Number of differential biomarkers in mesenchymal stromal cells
Time frame: Day 0
Results and safety
The study was stopped early (reason given: Achievement of scientific objectives). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Individual participant dataSharing planned: No
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Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
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Not yet recruitingPhase 1
ATRN-119 in Combination With Decitabine in Patients With TP53-Mutated AML or Higher-Risk MDS
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Denis Guyotat, PhD principal investigator
CHU de Saint-Etienne
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myelodysplastic Syndromes and Acute Myeloid Leukemia, run by Centre Hospitalier Universitaire de Saint Etienne at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Achievement of scientific objectives). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in cellular properties of mesenchymal stromal cells (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2023.