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Trial record 10 of 1807 for:    "bone marrow" | Recruiting, Not yet recruiting Studies

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

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ClinicalTrials.gov Identifier: NCT03233074
Recruitment Status : Recruiting
First Posted : July 28, 2017
Last Update Posted : April 26, 2019
Sponsor:
Collaborator:
Centre Hospitalier Universitaire de Saint Etienne
Information provided by (Responsible Party):
Institut de Cancérologie de la Loire

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).

Condition or disease Intervention/treatment
Myelodysplastic Syndromes Acute Myeloid Leukemia Cardio-vascular Surgery 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.

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Constitution of a Biological Cohort Following Bone Marrow Sampling From MDS or AML Patients and Age-matched Healthy Donors (COSMOS)
Actual Study Start Date : November 17, 2017
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : September 30, 2019


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 Name: 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 Name: Cellular properties of mesenchymal stromal cells




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Number of differential biomarkers in mesenchymal stromal cells [ Time Frame: Day 0 ]
    Number of differential biomarkers expressed by MDS or AML-derived mesenchymal stromal cells


Biospecimen Retention:   Samples With DNA
Bone marrow


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03233074


Contacts
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Contact: Denis Guyotat, PhD (0)4 77 91 70 70 ext +33 denis.guyotat@icloire.fr
Contact: Elisabeth Daguenet, PhD (0)4 77 91 70 89 ext +33 Elisabeth.daguenet@icloire.fr

Locations
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France
CHU de Saint-Etienne Recruiting
Saint-Priest-en-Jarez, France, 42270
Contact: Jean-François Fuzelier, PhD         
Principal Investigator: Jean-François Fuzelier, PhD         
Institut de Cancérologie Lucien Neuwirth Recruiting
Saint-Priest-en-Jarez, France, 42270
Contact: Denis Guyotat, PhD         
Principal Investigator: Denis Guyotat, PhD         
Sub-Investigator: Jérôme Cornillon, PhD         
Sub-Investigator: Fressia Honeyman, PhD         
Sub-Investigator: Caroline Lejeune, PhD         
Sub-Investigator: Christiane Mounier, PhD         
Sub-Investigator: Christelle Portois, PhD         
Sub-Investigator: Gilbert Soglu, PhD         
Sub-Investigator: Emmanuelle Tavernier, PhD         
Sponsors and Collaborators
Institut de Cancérologie de la Loire
Centre Hospitalier Universitaire de Saint Etienne
Investigators
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Principal Investigator: Denis Guyotat, PhD Institut de Cancérologie Lucien Neuwirth

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Responsible Party: Institut de Cancérologie de la Loire
ClinicalTrials.gov Identifier: NCT03233074     History of Changes
Other Study ID Numbers: 2017-0701
2017-A02088-45 ( Other Identifier: ANSM )
First Posted: July 28, 2017    Key Record Dates
Last Update Posted: April 26, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Institut de Cancérologie de la Loire:
Myelodysplastic Syndromes
Acute Myeloid Leukemia
Bone Marrow
Mesenchymal stromal cell
Healthy donor

Additional relevant MeSH terms:
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Leukemia, Myeloid
Leukemia, Myeloid, Acute
Myelodysplastic Syndromes
Preleukemia
Leukemia
Neoplasms by Histologic Type
Neoplasms
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions