<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03233074</url>
  </required_header>
  <id_info>
    <org_study_id>2017-0701</org_study_id>
    <secondary_id>2017-A02088-45</secondary_id>
    <nct_id>NCT03233074</nct_id>
  </id_info>
  <brief_title>Constitution of a Biological Cohort Following Bone Marrow Sampling From MDS or AML Patients and Age-matched Healthy Donors</brief_title>
  <acronym>COSMOS</acronym>
  <official_title>Constitution of a Biological Cohort Following Bone Marrow Sampling From MDS or AML Patients and Age-matched Healthy Donors (COSMOS)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire de Saint Etienne</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Institut de Cancérologie de la Loire</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Centre Hospitalier Universitaire de Saint Etienne</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      It is of clinical significance to better characterize the intrinsic defects harbored by&#xD;
      mesenchymal stromal cells (MSC) in Myelodysplastic syndromes (MDS) and acute myeloid leukemia&#xD;
      (AML) context, as compared to physiological conditions. Such research initiative aims to&#xD;
      dissect the cross-talk between malignant hematopoietic stem cells (HSC) and their bone marrow&#xD;
      (BM) partners in crime, further prospecting for innovative stromal-directed strategies for&#xD;
      the treatment of Myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Myelodysplastic syndromes (MDS) are a heterogeneous group of clonal malignancies that are&#xD;
      characterized by ineffective hematopoiesis, progressive bone marrow failure, cytogenetic and&#xD;
      molecular abnormalities, and increased risk for progression to acute myeloid leukemia (AML).&#xD;
      It is a well-accepted theory that MDS and AML originate from primary alterations of&#xD;
      hematopoietic stem cells (HSC) compartment, which confer a survival advantage to them at the&#xD;
      expense of physiological hematopoiesis. More recently, there is growing evidences regarding&#xD;
      the contribution of the bone marrow (BM) microenvironment to the pathogenesis of MDS and AML.&#xD;
      Of particular interest, several studies have pointed towards a pivotal role of mesenchymal&#xD;
      stromal cells (MSC), one of the main components of the BM niche, in the initiation and&#xD;
      propagation of myeloid disorders. In this context, it is of clinical significance to better&#xD;
      characterize the intrinsic defects harbored by MSC in MDS and AML context, as compared to&#xD;
      physiological conditions. Such research initiative aims to dissect the cross-talk between&#xD;
      malignant HSC and their BM partners in crime, further prospecting for innovative&#xD;
      stromal-directed strategies for the treatment of MDS and AML.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Achievement of scientific objectives&#xD;
  </why_stopped>
  <start_date type="Actual">November 17, 2017</start_date>
  <completion_date type="Actual">April 19, 2022</completion_date>
  <primary_completion_date type="Actual">April 19, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in cellular properties of mesenchymal stromal cells</measure>
    <time_frame>Day 0</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of differential biomarkers in mesenchymal stromal cells</measure>
    <time_frame>Day 0</time_frame>
    <description>Number of differential biomarkers expressed by MDS or AML-derived mesenchymal stromal cells</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">93</enrollment>
  <condition>Myelodysplastic Syndromes</condition>
  <condition>Acute Myeloid Leukemia</condition>
  <condition>Cardio-vascular Surgery</condition>
  <arm_group>
    <arm_group_label>Acute Myeloid Leukemia patients</arm_group_label>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy donors</arm_group_label>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Bone marrow analyses</intervention_name>
    <description>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.</description>
    <arm_group_label>Acute Myeloid Leukemia patients</arm_group_label>
    <arm_group_label>Healthy donors</arm_group_label>
    <other_name>Cellular properties of mesenchymal stromal cells</other_name>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Bone marrow&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Acute Myeloid Leukemia patients undergoing a bone marrow sampling for diagnosis purposes,&#xD;
        and healthy donors undergoing cardio-vascular surgery for their usual support.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with diagnosed myelodysplasia or acute myeloid leukemia (study place: ICLN) -&#xD;
             Specific to the cases cohort&#xD;
&#xD;
          -  Age-matched healthy donors undergoing a cardiovascular surgery - Specific to the&#xD;
             control cohort&#xD;
&#xD;
          -  Signed written informed consent form&#xD;
&#xD;
          -  Patient affiliated to a social security regimen or beneficiary of the same&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Medical history of hematological disorders&#xD;
&#xD;
          -  Thrombocytopenia, anemia…&#xD;
&#xD;
          -  Patient under guardianship or deprived of his liberty or any condition that may affect&#xD;
             the patient's ability to understand and sign the informed consent (art. L.1121-6,&#xD;
             L.112-7, L.1211-8, L.1211-9)&#xD;
&#xD;
          -  Pregnant or breastfeeding women&#xD;
&#xD;
          -  Refusing participation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Denis Guyotat, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU de Saint-Etienne</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU de Saint-Etienne</name>
      <address>
        <city>Saint-Priest-en-Jarez</city>
        <zip>42270</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Saint-Etienne</name>
      <address>
        <city>Saint-Étienne</city>
        <zip>42055</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>July 17, 2017</study_first_submitted>
  <study_first_submitted_qc>July 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2017</study_first_posted>
  <last_update_submitted>May 4, 2023</last_update_submitted>
  <last_update_submitted_qc>May 4, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Myelodysplastic Syndromes</keyword>
  <keyword>Acute Myeloid Leukemia</keyword>
  <keyword>Bone Marrow</keyword>
  <keyword>Mesenchymal stromal cell</keyword>
  <keyword>Healthy donor</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leukemia, Myeloid</mesh_term>
    <mesh_term>Leukemia, Myeloid, Acute</mesh_term>
    <mesh_term>Preleukemia</mesh_term>
    <mesh_term>Myelodysplastic Syndromes</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03233074
org study id: 2017-0701
secondary id: 2017-A02088-45
nct id: NCT03233074
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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).
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.
observational model: Case-Control
time perspective: Prospective
measure: Changes in cellular properties of mesenchymal stromal cells
time frame: Day 0
description: 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.
measure: Number of differential biomarkers in mesenchymal stromal cells
time frame: Day 0
description: Number of differential biomarkers expressed by MDS or AML-derived mesenchymal stromal cells
arm group label: Acute Myeloid Leukemia patients
description: 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.
arm group label: Healthy donors
description: 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.
intervention type: Other
intervention name: Bone marrow analyses
description: 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.
arm group label: Acute Myeloid Leukemia patients
arm group label: Healthy donors
other name: Cellular properties of mesenchymal stromal cells
Bone marrow
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 50 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Denis Guyotat, PhD
role: Principal Investigator
affiliation: CHU de Saint-Etienne
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Leukemia, Myeloid
mesh term: Leukemia, Myeloid, Acute
mesh term: Preleukemia
mesh term: Myelodysplastic Syndromes
sharing ipd: No