<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/NCT03801005</url>
  </required_header>
  <id_info>
    <org_study_id>2018-43</org_study_id>
    <nct_id>NCT03801005</nct_id>
  </id_info>
  <brief_title>Immunophenotyping of Blast Cells and Immune Effector Cells in Peripheral Whole Blood and Bone Marrow Samples From AML and MDS Patients (AML)</brief_title>
  <official_title>Immunophenotyping of Blast Cells and Immune Effector Cells in Peripheral Whole Blood and Bone Marrow Samples From AML and MDS Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique Hopitaux De Marseille</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique Hopitaux De Marseille</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to evaluate the immune profile of blast cells and immune&#xD;
      effector cells in paired peripheral whole blood and bone marrow samples from AML and MDS&#xD;
      patients by standardized flow cytometry. A special emphasis will be focused on monitoring&#xD;
      expression of CD200 as well as PGP-170 (MDR1) on blasts cells.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 9, 2019</start_date>
  <completion_date type="Actual">March 25, 2022</completion_date>
  <primary_completion_date type="Actual">March 25, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>evaluate the immune profile of blast cells and immune effector cells in paired peripheral whole blood and bone marrow samples from AML and MDS patients by standardized flow cytometry.</measure>
    <time_frame>9 mounths</time_frame>
  </primary_outcome>
  <enrollment type="Actual">38</enrollment>
  <condition>Leukemia</condition>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Blood and Marrow sample</intervention_name>
    <description>Twenty patients will be included in a prospective way over a period of nine months. No additional medullary or serum samples will be carried out in addition to those required for the clinical routine. Only an additional blood sample taken during a routine blood test will be recovered as part of the research. Just as some leftover bone marrow, taken as part of a usual unused follow-up will be recovered as part of this trial.&#xD;
The persons concerned will be recruited on the occasion of their hospitalisation in one of the hematology services participating in the research, or during their consultation with one of the hematologists of the corresponding service (or services). On this occasion, detailed information on their pathology and research will be given, as well as the information document on the proposed research protocol.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patient with myelodysplastic syndrome (with excess blasts) or acute myeloid leukemia&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt; 18&#xD;
&#xD;
          -  No pregnant woman&#xD;
&#xD;
          -  Patient with myelodysplastic syndrome (with excess blasts) or acute myeloid leukemia&#xD;
&#xD;
          -  Presence of a monitored serum blastose&#xD;
&#xD;
          -  Patient who can obtain free and informed consent (speaks French, no guardianship or&#xD;
             curatorship)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Minor Patient (&lt; 18 years old)&#xD;
&#xD;
          -  Medical or psychological Condition that could interact with the ability to understand&#xD;
             the study,&#xD;
&#xD;
          -  Pregnant or lactating women,&#xD;
&#xD;
          -  Major persons under guardianship or under the protection of justice&#xD;
&#xD;
          -  Persons deprived of their liberty by a judicial or administrative decision&#xD;
&#xD;
          -  Lack of information and opposition to its participation in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Assistance Publique - Hopitaux de Marseille</name>
      <address>
        <city>Marseille</city>
        <zip>13387</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>January 9, 2019</study_first_submitted>
  <study_first_submitted_qc>January 9, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 11, 2019</study_first_posted>
  <last_update_submitted>January 23, 2023</last_update_submitted>
  <last_update_submitted_qc>January 23, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 25, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT03801005
org study id: 2018-43
nct id: NCT03801005
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The objective of this study is to evaluate the immune profile of blast cells and immune
      effector cells in paired peripheral whole blood and bone marrow samples from AML and MDS
      patients by standardized flow cytometry. A special emphasis will be focused on monitoring
      expression of CD200 as well as PGP-170 (MDR1) on blasts cells.
observational model: Other
time perspective: Prospective
measure: evaluate the immune profile of blast cells and immune effector cells in paired peripheral whole blood and bone marrow samples from AML and MDS patients by standardized flow cytometry.
time frame: 9 mounths
intervention type: Biological
intervention name: Blood and Marrow sample
description: Twenty patients will be included in a prospective way over a period of nine months. No additional medullary or serum samples will be carried out in addition to those required for the clinical routine. Only an additional blood sample taken during a routine blood test will be recovered as part of the research. Just as some leftover bone marrow, taken as part of a usual unused follow-up will be recovered as part of this trial.
The persons concerned will be recruited on the occasion of their hospitalisation in one of the hematology services participating in the research, or during their consultation with one of the hematologists of the corresponding service (or services). On this occasion, detailed information on their pathology and research will be given, as well as the information document on the proposed research protocol.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor