<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/NCT01692444</url>
  </required_header>
  <id_info>
    <org_study_id>CHUBX 2011/34</org_study_id>
    <nct_id>NCT01692444</nct_id>
  </id_info>
  <brief_title>Role of Fibrocytes in the Bronchial Remodelling of Chronic Obstructive Pulmonary Disease</brief_title>
  <acronym>FIBROCHIR</acronym>
  <official_title>Role of Fibrocytes in the Bronchial Remodelling of Chronic Obstructive Pulmonary Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Bordeaux</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Bordeaux</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Airway remodelling is an abnormal tissue repair following bronchial inflammation, which&#xD;
      contributes to none reversible pathological features, such as bronchial and peri-bronchial&#xD;
      fibrosis. It also influences the prognosis of Chronic Obstructive Pulmonary Disease (COPD)&#xD;
      and its mechanisms remain largely unknown. The role of fibrocytes has been demonstrated in&#xD;
      the pathophysiology of asthma, lung fibrosis or pulmonary hypertension. However, the&#xD;
      recruitment of blood fibrocytes and their involvement in COPD airway remodelling remain&#xD;
      unknown.&#xD;
&#xD;
      The main objective of the study is to analyse the distribution and quantify the number of the&#xD;
      peri-bronchial and blood circulating fibrocytes in patients with different stages of COPD&#xD;
      compared to control subjects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 10, 2013</start_date>
  <completion_date type="Actual">May 20, 2016</completion_date>
  <primary_completion_date type="Actual">May 20, 2016</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>Increased number of peri-bronchial and blood circulating fibrocytes gradually in each stages of COPD and compared to control subjects.</measure>
    <time_frame>Lung tissues and blood samples will be collected at inclusion visit during surgery (Day 0)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Characterization of fibrocytes: expression of chemokines receptors, Toll Like Receptors, HLA class II</measure>
    <time_frame>Lung tissues and blood samples will be collected at inclusion visit during surgery (Day 0)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between lung attenuation and the number of fibrocytes</measure>
    <time_frame>Assessed one year after inclusion visit (i.e. surgery date =Day 0)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between plethysmography and the number of fibrocytes.</measure>
    <time_frame>Assessed one year after inclusion visit (i.e. surgery date = Day 0)</time_frame>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">50</enrollment>
  <condition>Chronic Obstructive Pulmonary Disease</condition>
  <arm_group>
    <arm_group_label>COPD</arm_group_label>
    <description>15 patients with COPD from 1 to 4 according to the GOLD 2011</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non smoker Control</arm_group_label>
    <description>15 patients without COPD and no smoking history</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Smoker Control</arm_group_label>
    <description>15 patients without COPD but a smoking history</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Lung tissue form surgery such as lobectomy or pneumonectomy,whole blood sample for fibrocytes&#xD;
      analysis&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Controls and COPD patients will be recruited during surgical visit or hospitalization in&#xD;
        thoracic surgery department before surgery.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female aged more than 40 yr&#xD;
&#xD;
          -  Patient needed a thoracic surgery such as lobectomy for cancer or lung transplantation&#xD;
             or lung reduction volume surgery.&#xD;
&#xD;
          -  COPD group: diagnostic of COPD and differentiation of the stage from 1 to 4 according&#xD;
             to the GOLD guidelines.&#xD;
&#xD;
          -  Control group: subjects with normal lung function testing and no chronic symptoms&#xD;
             (cough or expectoration). Subjects will be separated in 2 groups according to smoking&#xD;
             history (Never smokers, smokers (former or current) and paired to patients according&#xD;
             to age and sex.&#xD;
&#xD;
          -  with a written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject without any social security or health insurance&#xD;
&#xD;
          -  Asthma, lung fibrosis or idiopathic pulmonary hypertension&#xD;
&#xD;
          -  Chronic viral infections (hepatitis, HIV)&#xD;
&#xD;
          -  Pregnant woman or breastfeeding&#xD;
&#xD;
          -  Subject included for cancer surgery with a Pn0 diagnosis not confirmed after the&#xD;
             intervention.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nicholas MOORE, MD-PhD</last_name>
    <role>Study Chair</role>
    <affiliation>University Hospital, Bordeaux</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University hospital of Bordeaux, Hôpital du Haut Lévêque</name>
      <address>
        <city>Pessac</city>
        <zip>33604</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>September 17, 2012</study_first_submitted>
  <study_first_submitted_qc>September 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2012</study_first_posted>
  <last_update_submitted>February 8, 2022</last_update_submitted>
  <last_update_submitted_qc>February 8, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 9, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Chronic Obstructive Pulmonary Disease</keyword>
  <keyword>Fibrosis</keyword>
  <keyword>Fibroblast</keyword>
  <keyword>Lung attenuation</keyword>
  <keyword>Pletysmography</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases</mesh_term>
    <mesh_term>Lung Diseases, Obstructive</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic Obstructive</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/NCT01692444
org study id: CHUBX 2011/34
nct id: NCT01692444
lead sponsor: 
has dmc: No
Airway remodelling is an abnormal tissue repair following bronchial inflammation, which
      contributes to none reversible pathological features, such as bronchial and peri-bronchial
      fibrosis. It also influences the prognosis of Chronic Obstructive Pulmonary Disease (COPD)
      and its mechanisms remain largely unknown. The role of fibrocytes has been demonstrated in
      the pathophysiology of asthma, lung fibrosis or pulmonary hypertension. However, the
      recruitment of blood fibrocytes and their involvement in COPD airway remodelling remain
      unknown.

      The main objective of the study is to analyse the distribution and quantify the number of the
      peri-bronchial and blood circulating fibrocytes in patients with different stages of COPD
      compared to control subjects.
observational model: Case-Control
time perspective: Prospective
measure: Increased number of peri-bronchial and blood circulating fibrocytes gradually in each stages of COPD and compared to control subjects.
time frame: Lung tissues and blood samples will be collected at inclusion visit during surgery (Day 0)
measure: Characterization of fibrocytes: expression of chemokines receptors, Toll Like Receptors, HLA class II
time frame: Lung tissues and blood samples will be collected at inclusion visit during surgery (Day 0)
measure: Correlation between lung attenuation and the number of fibrocytes
time frame: Assessed one year after inclusion visit (i.e. surgery date =Day 0)
measure: Correlation between plethysmography and the number of fibrocytes.
time frame: Assessed one year after inclusion visit (i.e. surgery date = Day 0)
arm group label: COPD
description: 15 patients with COPD from 1 to 4 according to the GOLD 2011
arm group label: Non smoker Control
description: 15 patients without COPD and no smoking history
arm group label: Smoker Control
description: 15 patients without COPD but a smoking history
Lung tissue form surgery such as lobectomy or pneumonectomy,whole blood sample for fibrocytes
      analysis
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
last name: Nicholas MOORE, MD-PhD
role: Study Chair
affiliation: University Hospital, Bordeaux
facility: 
country: France
responsible party type: Sponsor
mesh term: Lung Diseases
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive