<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/NCT03250897</url>
  </required_header>
  <id_info>
    <org_study_id>35RC16_3055_Caract-Aires-2016</org_study_id>
    <nct_id>NCT03250897</nct_id>
  </id_info>
  <brief_title>Phenotypic Characterization of Alveolar Macrophages 2016 (Caract-Aires-2016)</brief_title>
  <acronym>Caract-Aires</acronym>
  <official_title>Phenotypic Characterization of Alveolar Macrophages 2016</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rennes University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rennes University Hospital</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>
      The aim of the study is to investigate by flow cytometry the phenotype of alveolar&#xD;
      macrophages (AMs) isolated from patients with non-infectious lung diseases.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Although alveolar macrophages (AMs) represent the main immune cell population in the human&#xD;
      lungs, consensus on their phenotypic characterization is still missing.&#xD;
&#xD;
      Current translational protocols use human AMs obtained by invasive methods (broncho-alveolar&#xD;
      lavage and lung biopsy) or differentiate macrophages from blood monocytes cultured in the&#xD;
      presence of growth factors such as macrophage colony-stimulating factor (M-CSF) or&#xD;
      granulocyte-macrophage colony-stimulating factor (GM-CSF). The group has already published&#xD;
      the phenotypic and functional comparison of human blood monocyte-derived macrophages&#xD;
      differentiated with M-CSF or GM-CSF. Aim of this study is to use a multi-staining flow&#xD;
      cytometry (FACS analysis) to better characterize the phenotype of AMs isolated from&#xD;
      broncho-alveolar lavage fluids of patients affected by non-infectious lung diseases. The FACS&#xD;
      profiles of AMs will be further compared to the phenotypic profile of blood monocyte-derived&#xD;
      macrophages differentiated in the presence of GM-CSF or M-CSF. The results of this study will&#xD;
      allow to define the most valid in vitro model of AMs in a non-infectious setting.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 2016</start_date>
  <completion_date type="Anticipated">September 2018</completion_date>
  <primary_completion_date type="Anticipated">December 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>To investigate by flow cytometry the phenotype of alveolar macrophages (AMs) isolated from broncho-alveolar lavage fluids of patients with non-infectious lung diseases.</measure>
    <time_frame>1 year</time_frame>
    <description>Characterization of membrane proteins by multi-staining flow cytometry (FACS analysis)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To compare the phenotypic profile of AMs from broncho-alveolar lavage fluids of patients with non-infectious lung diseases to that of blood monocyte-derived macrophages differentiated in the presence of GM-CSF or M-CSF and obtained from healthy donors</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <enrollment type="Anticipated">18</enrollment>
  <condition>Lung Diseases</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Broncho-alveolar lavage fluids of patients with non-infectious lung diseases&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients affected by non-infectious lung diseases older than 18 years&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients affected by non-infectious lung diseases and for whom a broncho-alveolar&#xD;
             lavage is scheduled for their medical care in the pulmonary division&#xD;
&#xD;
          -  Patient Information leaflet provided&#xD;
&#xD;
          -  Written informed consent of the patient&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A suspected respiratory infection&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stéphane Jouneau, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rennes University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Stéphane Jouneau, Professor</last_name>
    <phone>0299282481</phone>
    <email>stephane.jouneau@chu-rennes.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Pneumology Division</name>
      <address>
        <city>Rennes</city>
        <zip>35033</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Stéphane Jouneau, Professor</last_name>
      <phone>+33 2 99 28 24 81</phone>
      <email>stephane.jouneau@chu-rennes.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 11, 2017</study_first_submitted>
  <study_first_submitted_qc>August 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 16, 2017</study_first_posted>
  <last_update_submitted>August 11, 2017</last_update_submitted>
  <last_update_submitted_qc>August 11, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 16, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Alveolar macrophages</keyword>
  <keyword>Blood monocyte-derived macrophages</keyword>
  <keyword>FACS analysis</keyword>
  <keyword>Broncho-alveolar lavage fluids</keyword>
  <keyword>Non-infectious lung diseases</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases</mesh_term>
  </condition_browse>
  <!-- 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/NCT03250897
org study id: 35RC16_3055_Caract-Aires-2016
nct id: NCT03250897
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of the study is to investigate by flow cytometry the phenotype of alveolar
      macrophages (AMs) isolated from patients with non-infectious lung diseases.
Although alveolar macrophages (AMs) represent the main immune cell population in the human
      lungs, consensus on their phenotypic characterization is still missing.

      Current translational protocols use human AMs obtained by invasive methods (broncho-alveolar
      lavage and lung biopsy) or differentiate macrophages from blood monocytes cultured in the
      presence of growth factors such as macrophage colony-stimulating factor (M-CSF) or
      granulocyte-macrophage colony-stimulating factor (GM-CSF). The group has already published
      the phenotypic and functional comparison of human blood monocyte-derived macrophages
      differentiated with M-CSF or GM-CSF. Aim of this study is to use a multi-staining flow
      cytometry (FACS analysis) to better characterize the phenotype of AMs isolated from
      broncho-alveolar lavage fluids of patients affected by non-infectious lung diseases. The FACS
      profiles of AMs will be further compared to the phenotypic profile of blood monocyte-derived
      macrophages differentiated in the presence of GM-CSF or M-CSF. The results of this study will
      allow to define the most valid in vitro model of AMs in a non-infectious setting.
observational model: Cohort
time perspective: Prospective
measure: To investigate by flow cytometry the phenotype of alveolar macrophages (AMs) isolated from broncho-alveolar lavage fluids of patients with non-infectious lung diseases.
time frame: 1 year
description: Characterization of membrane proteins by multi-staining flow cytometry (FACS analysis)
measure: To compare the phenotypic profile of AMs from broncho-alveolar lavage fluids of patients with non-infectious lung diseases to that of blood monocyte-derived macrophages differentiated in the presence of GM-CSF or M-CSF and obtained from healthy donors
time frame: 1 year
Broncho-alveolar lavage fluids of patients with non-infectious lung diseases
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Stéphane Jouneau, Professor
role: Principal Investigator
affiliation: Rennes University Hospital
last name: Stéphane Jouneau, Professor
phone: 0299282481
email: stephane.jouneau@chu-rennes.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Lung Diseases