<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/NCT03811600</url>
  </required_header>
  <id_info>
    <org_study_id>2019-A00029-48</org_study_id>
    <nct_id>NCT03811600</nct_id>
  </id_info>
  <brief_title>Exosomes Implication in PD1-PD-L1 Activation in OSAS</brief_title>
  <acronym>ExoSAS</acronym>
  <official_title>Exosomes Implication in PD1-PD-L1 Pathway Activation in Obstructive Sleep Apnea Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Angers</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Angers</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>
      An increased occurrence of cancer associated mortality has been described in patients with&#xD;
      Obstructive Sleep Apnea Syndrome (OSAS). This association might be partially explained by an&#xD;
      impaired cellular immune response that has been described in OSAS. Is has been suggested that&#xD;
      OSAS impact immune cells by upregulation of the PD-1/PD-L1 pathway. Exosomes are small&#xD;
      membrane vesicles released by numerous cells in the bloodstream. Exosomes have been shown to&#xD;
      be implicated in cancer cells proliferation via a PD-1/PD-L1 pathway activation.&#xD;
&#xD;
      This study will evaluate exosomal PD-1/PD-L1 expression in patients with OSAS as compared to&#xD;
      controls and will further investigate their impact on immune cells function and proliferation&#xD;
      capacities.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 3, 2019</start_date>
  <completion_date type="Actual">October 14, 2020</completion_date>
  <primary_completion_date type="Actual">October 14, 2020</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>exosomal PD1 expression</measure>
    <time_frame>at baseline</time_frame>
    <description>Peripheral blood (≈20 ml) will be collected from non-OSAS or OSAS subjects on EDTA-coated tubes. Exosomes will be isolated by centrifugation. For detecting exosome-associated surface proteins by flow cytometry, exosomes will be first captured on magnetic beads. The bead/exosome complexes will be then co-incubated with the labeled detection antibodies, either anti-PD1. Next, the complexes will be washed 3x resuspended in 300uL of PBS for antigen detection by flow cytometry.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>exosomal PD-L1 expression</measure>
    <time_frame>at baseline</time_frame>
    <description>Peripheral blood (≈20 ml) will be collected from non-OSAS or OSAS subjects on EDTA-coated tubes. Exosomes will be isolated by centrifugation. For detecting exosome-associated surface proteins by flow cytometry, exosomes will be first captured on magnetic beads. The bead/exosome complexes will be then co-incubated with the labeled detection antibodies, either anti-PD-L1. Next, the complexes will be washed 3x resuspended in 300uL of PBS for antigen detection by flow cytometry.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">90</enrollment>
  <condition>Sleep Apnea Syndromes, Obstructive</condition>
  <condition>Cancer</condition>
  <arm_group>
    <arm_group_label>OSAS patients</arm_group_label>
    <description>45 patients investigated for suspected OSAS with an apnea hypopnea index ≥15 per hour</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non OSAS patients</arm_group_label>
    <description>45 patients investigated for suspected OSAS with an apnea hypopnea index &lt;15 per hour</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>PD1/PD-L1 exosomal expression</intervention_name>
    <description>exosomal PD1/PD-L1 expression</description>
    <arm_group_label>Non OSAS patients</arm_group_label>
    <arm_group_label>OSAS patients</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Plasma and serum&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients investigated by sleep recording for suspected OSAS will be included in the study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients requiring a sleep recording for suspected OSAS&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Préviously treated OSAS&#xD;
&#xD;
          -  Cancer past history&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Cognitif impairment&#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>Laboratoire du Sommeil, Département de Pneumologie, CHU d'Angers</name>
      <address>
        <city>Angers</city>
        <zip>49100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>January 15, 2019</study_first_submitted>
  <study_first_submitted_qc>January 18, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 22, 2019</study_first_posted>
  <last_update_submitted>February 9, 2023</last_update_submitted>
  <last_update_submitted_qc>February 9, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 10, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Apnea Syndromes</mesh_term>
    <mesh_term>Sleep Apnea, Obstructive</mesh_term>
    <mesh_term>Syndrome</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/NCT03811600
org study id: 2019-A00029-48
nct id: NCT03811600
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
An increased occurrence of cancer associated mortality has been described in patients with
      Obstructive Sleep Apnea Syndrome (OSAS). This association might be partially explained by an
      impaired cellular immune response that has been described in OSAS. Is has been suggested that
      OSAS impact immune cells by upregulation of the PD-1/PD-L1 pathway. Exosomes are small
      membrane vesicles released by numerous cells in the bloodstream. Exosomes have been shown to
      be implicated in cancer cells proliferation via a PD-1/PD-L1 pathway activation.

      This study will evaluate exosomal PD-1/PD-L1 expression in patients with OSAS as compared to
      controls and will further investigate their impact on immune cells function and proliferation
      capacities.
observational model: Case-Control
time perspective: Cross-Sectional
measure: exosomal PD1 expression
time frame: at baseline
description: Peripheral blood (≈20 ml) will be collected from non-OSAS or OSAS subjects on EDTA-coated tubes. Exosomes will be isolated by centrifugation. For detecting exosome-associated surface proteins by flow cytometry, exosomes will be first captured on magnetic beads. The bead/exosome complexes will be then co-incubated with the labeled detection antibodies, either anti-PD1. Next, the complexes will be washed 3x resuspended in 300uL of PBS for antigen detection by flow cytometry.
measure: exosomal PD-L1 expression
time frame: at baseline
description: Peripheral blood (≈20 ml) will be collected from non-OSAS or OSAS subjects on EDTA-coated tubes. Exosomes will be isolated by centrifugation. For detecting exosome-associated surface proteins by flow cytometry, exosomes will be first captured on magnetic beads. The bead/exosome complexes will be then co-incubated with the labeled detection antibodies, either anti-PD-L1. Next, the complexes will be washed 3x resuspended in 300uL of PBS for antigen detection by flow cytometry.
arm group label: OSAS patients
description: 45 patients investigated for suspected OSAS with an apnea hypopnea index ≥15 per hour
arm group label: Non OSAS patients
description: 45 patients investigated for suspected OSAS with an apnea hypopnea index <15 per hour
intervention type: Diagnostic Test
intervention name: PD1/PD-L1 exosomal expression
description: exosomal PD1/PD-L1 expression
arm group label: Non OSAS patients
arm group label: OSAS patients
Plasma and serum
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Sleep Apnea Syndromes
mesh term: Sleep Apnea, Obstructive
mesh term: Syndrome