<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/NCT04473742</url>
  </required_header>
  <id_info>
    <org_study_id>35RC20_8878_MacFibOsis</org_study_id>
    <nct_id>NCT04473742</nct_id>
  </id_info>
  <brief_title>Effects of Silica and Asbestos Fibres on the Efferocytosis Capacities of Macrophages</brief_title>
  <acronym>MacFibOsis</acronym>
  <official_title>Effects of Silica and Asbestos Fibres on the Efferocytosis Capacities of Macrophages</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>
      Evaluation of the efferocytosis capacities of blood Monocyte Derived Macrophages (MDM) from&#xD;
      patients with a history of asbestosis or silica exposure and comparison of these capacities&#xD;
      with those of MDM from healthy donors.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with a proven history or current exposure will have 4 EDTA tubes drawn,&#xD;
      approximately 24mL of fresh whole blood for efferocytosis assessment and :&#xD;
&#xD;
        -  2 x 6mL serum tubes for the assessment of Antinuclear Antibody (ANA) positivity, serum&#xD;
           high-mobility group box 1 (HMGB1) and osteopontin for patients exposed to asbestos&#xD;
&#xD;
        -  1 x 6mL serum tube for serum HMGB1 and osteopontin for patients exposed to silica&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 31, 2021</start_date>
  <completion_date type="Actual">December 15, 2021</completion_date>
  <primary_completion_date type="Actual">December 15, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Efferocytosis Index (EI) calculation (%) defined as the number of efferocyte MDM / total number of MDM</measure>
    <time_frame>Through study completion, an average of 2 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>EI calculation in patients positive for ANA vs patients negative for ANA</measure>
    <time_frame>Through study completion, an average of 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum concentration of HMGB1 and Osteopontin (SPP1) by ELISA</measure>
    <time_frame>Through study completion, an average of 2 years</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">23</enrollment>
  <condition>History of Exposure to Silica or Asbestosis</condition>
  <condition>Positive Testing for ANA as a Marker of Systemic Autoimmune Diseases</condition>
  <arm_group>
    <arm_group_label>Patients exposed to silica</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Patients exposed to asbestos fibres</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Blood collection</intervention_name>
    <description>4 EDTA tubes for 24 mL blood collection</description>
    <arm_group_label>Patients exposed to asbestos fibres</arm_group_label>
    <arm_group_label>Patients exposed to silica</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Blood sample</intervention_name>
    <description>2 drying tubes for 12 mL blood collection</description>
    <arm_group_label>Patients exposed to asbestos fibres</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Blood sample</intervention_name>
    <description>1 drying tube for 6 mL blood collection</description>
    <arm_group_label>Patients exposed to silica</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient older than 18 Yo&#xD;
&#xD;
          -  Addressed to the department of occupational disease&#xD;
&#xD;
          -  With a history of asbestosis or silica exposure evaluated by a dedicated questionnaire&#xD;
             and a throughout examination of the history of occupations, according to standard&#xD;
             procedures for the follow-up of at risk workers.&#xD;
&#xD;
          -  Persons who received an oral and written information on the protocol and signed the&#xD;
             informed consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or breastfeeding women&#xD;
&#xD;
          -  Subject legally protected (under judicial protection, guardianship), persons deprived&#xD;
             of liberty&#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>CHU de Rennes</name>
      <address>
        <city>Rennes</city>
        <zip>35033</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>July 13, 2020</study_first_submitted>
  <study_first_submitted_qc>July 13, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 16, 2020</study_first_posted>
  <last_update_submitted>January 3, 2022</last_update_submitted>
  <last_update_submitted_qc>January 3, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 4, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>efferocytosis</keyword>
  <keyword>macrophages</keyword>
  <keyword>silica</keyword>
  <keyword>asbestosis</keyword>
  <keyword>HMGB1</keyword>
  <keyword>osteopontin</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Asbestosis</mesh_term>
    <mesh_term>Autoimmune Diseases</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/NCT04473742
org study id: 35RC20_8878_MacFibOsis
nct id: NCT04473742
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Evaluation of the efferocytosis capacities of blood Monocyte Derived Macrophages (MDM) from
      patients with a history of asbestosis or silica exposure and comparison of these capacities
      with those of MDM from healthy donors.
Patients with a proven history or current exposure will have 4 EDTA tubes drawn,
      approximately 24mL of fresh whole blood for efferocytosis assessment and :

        -  2 x 6mL serum tubes for the assessment of Antinuclear Antibody (ANA) positivity, serum
           high-mobility group box 1 (HMGB1) and osteopontin for patients exposed to asbestos

        -  1 x 6mL serum tube for serum HMGB1 and osteopontin for patients exposed to silica
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Efferocytosis Index (EI) calculation (%) defined as the number of efferocyte MDM / total number of MDM
time frame: Through study completion, an average of 2 years
measure: EI calculation in patients positive for ANA vs patients negative for ANA
time frame: Through study completion, an average of 2 years
measure: Serum concentration of HMGB1 and Osteopontin (SPP1) by ELISA
time frame: Through study completion, an average of 2 years
arm group label: Patients exposed to silica
arm group type: Experimental
arm group label: Patients exposed to asbestos fibres
arm group type: Active Comparator
intervention type: Biological
intervention name: Blood collection
description: 4 EDTA tubes for 24 mL blood collection
arm group label: Patients exposed to asbestos fibres
arm group label: Patients exposed to silica
intervention type: Biological
intervention name: Blood sample
description: 2 drying tubes for 12 mL blood collection
arm group label: Patients exposed to asbestos fibres
intervention type: Biological
intervention name: Blood sample
description: 1 drying tube for 6 mL blood collection
arm group label: Patients exposed to silica
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Asbestosis
mesh term: Autoimmune Diseases
sharing ipd: No