<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/NCT03240198</url>
  </required_header>
  <id_info>
    <org_study_id>MB2PROF</org_study_id>
    <nct_id>NCT03240198</nct_id>
  </id_info>
  <brief_title>Biological Markers for Professional COPD</brief_title>
  <acronym>MB2PROF</acronym>
  <official_title>Marqueurs Biologiques Des Bronchopneumopathies Chroniques Obstructives Professionnelles</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Intercommunal Creteil</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Centre Hospitalier Universitaire de Besancon</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Hospital, Bordeaux</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Hospital, Caen</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Hospital, Lille</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Centre Hospitalier Le Havre</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Henri Mondor University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Centre Hospitalier Intercommunal Creteil</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Chronic obstructive pulmonary disease (COPD) is a frequent disease, mainly linked to tobacco&#xD;
      smoking leading to chronic respiratory failure. It is characterized by an inflammatory spate&#xD;
      with modification of protease-antiprotease and oxidant-antioxydant balances. Local&#xD;
      modifications are associated with systemic changes. Many occupational factors have been&#xD;
      associated with an excess of COPD in epidemiological studies, however without identification&#xD;
      of any specific clinical or biological phenotype.&#xD;
&#xD;
      Pathophysiological pathways involved in COPD might be different according to etiologic&#xD;
      agents. Therefore, it is important to focus research on blood biomarkers associated with some&#xD;
      well-characterized occupational COPD.&#xD;
&#xD;
      The objectives of MB2PROF project are:&#xD;
&#xD;
        1. To build the first multicentric cohort of cases of occupational COPD, with collection of&#xD;
           plasma and DNA samples,&#xD;
&#xD;
        2. To study the evolution of clinical and lung function parameters of occupational COPD in&#xD;
           comparison with non occupational COPD during a follow-up study,&#xD;
&#xD;
        3. To identify biological phenotypes of COPD associated to a given etiological agent.&#xD;
&#xD;
      The methodology includes:&#xD;
&#xD;
        1. The constitution of a cohort with a clinical and biological follow-up during 5 years.&#xD;
           Subjects will be recruited in 7 occupational diseases departments, with the&#xD;
           collaboration of Pneumology departments.&#xD;
&#xD;
           Four groups of males subjects will be recruited (G1 : occupational COPD (6 groups of 60&#xD;
           subjects, corresponding to 6 groups of occupational agents) ; G2 : non occupational COPD&#xD;
           (n = 60) ; G3 : subjects with similar occupational exposure to G1 subjects but without&#xD;
           COPD (6 groups of 60 subjects) ; G4 : subjects free of occupational exposure and of COPD&#xD;
           (n = 60)), paired on tobacco-smoking and age. For each subject, information on clinical&#xD;
           data, lung function parameters, occupation history and blood samples will be collected.&#xD;
&#xD;
        2. The identification of biomarkers, using proteomic and genomic approaches according to&#xD;
           subgroups (with different etiologies) of occupational COPD,&#xD;
&#xD;
        3. The study of molecular pathways identified in these subgroups, with in vitro and in vivo&#xD;
           studies The MB2PROF project is an original and ambitious multidisciplinary and&#xD;
           translational project. The constitution of well-characterized COPD cases cohort should&#xD;
           allow the identification of biomarkers and molecular pathways associated with some&#xD;
           subgroup of subjects, and improve the knowledge of mechanisms involved.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2010</start_date>
  <completion_date type="Anticipated">January 2021</completion_date>
  <primary_completion_date type="Actual">January 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>C Protein Reactive</measure>
    <time_frame>at year 1</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>blood inflammatory markers</measure>
    <time_frame>at year 1</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>C Protein Reactive</measure>
    <time_frame>every year during 5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>blood inflammatory markers</measure>
    <time_frame>every year during 5 years</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">400</enrollment>
  <condition>Copd</condition>
  <arm_group>
    <arm_group_label>COPD</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Controls</arm_group_label>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        COPD and healthy subjects exposed to tobacco smoking and/or to occupational dust&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  COPD&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Other obstructive disease&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>CHI Créteil</name>
      <address>
        <city>Créteil</city>
        <zip>94000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Pascal Andujar, MD PhD</last_name>
      <phone>33 1 57 02 20 95</phone>
      <email>pascal.andujar@chicreteil.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>September 23, 2016</study_first_submitted>
  <study_first_submitted_qc>August 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2017</study_first_posted>
  <last_update_submitted>August 29, 2017</last_update_submitted>
  <last_update_submitted_qc>August 29, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 30, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Centre Hospitalier Intercommunal Creteil</investigator_affiliation>
    <investigator_full_name>Pascal ANDUJAR</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>occupational</keyword>
  <keyword>cohort</keyword>
  <keyword>biomarkers</keyword>
  <!-- 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/NCT03240198
org study id: MB2PROF
nct id: NCT03240198
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
Chronic obstructive pulmonary disease (COPD) is a frequent disease, mainly linked to tobacco
      smoking leading to chronic respiratory failure. It is characterized by an inflammatory spate
      with modification of protease-antiprotease and oxidant-antioxydant balances. Local
      modifications are associated with systemic changes. Many occupational factors have been
      associated with an excess of COPD in epidemiological studies, however without identification
      of any specific clinical or biological phenotype.

      Pathophysiological pathways involved in COPD might be different according to etiologic
      agents. Therefore, it is important to focus research on blood biomarkers associated with some
      well-characterized occupational COPD.

      The objectives of MB2PROF project are:

        1. To build the first multicentric cohort of cases of occupational COPD, with collection of
           plasma and DNA samples,

        2. To study the evolution of clinical and lung function parameters of occupational COPD in
           comparison with non occupational COPD during a follow-up study,

        3. To identify biological phenotypes of COPD associated to a given etiological agent.

      The methodology includes:

        1. The constitution of a cohort with a clinical and biological follow-up during 5 years.
           Subjects will be recruited in 7 occupational diseases departments, with the
           collaboration of Pneumology departments.

           Four groups of males subjects will be recruited (G1 : occupational COPD (6 groups of 60
           subjects, corresponding to 6 groups of occupational agents) ; G2 : non occupational COPD
           (n = 60) ; G3 : subjects with similar occupational exposure to G1 subjects but without
           COPD (6 groups of 60 subjects) ; G4 : subjects free of occupational exposure and of COPD
           (n = 60)), paired on tobacco-smoking and age. For each subject, information on clinical
           data, lung function parameters, occupation history and blood samples will be collected.

        2. The identification of biomarkers, using proteomic and genomic approaches according to
           subgroups (with different etiologies) of occupational COPD,

        3. The study of molecular pathways identified in these subgroups, with in vitro and in vivo
           studies The MB2PROF project is an original and ambitious multidisciplinary and
           translational project. The constitution of well-characterized COPD cases cohort should
           allow the identification of biomarkers and molecular pathways associated with some
           subgroup of subjects, and improve the knowledge of mechanisms involved.
observational model: Case-Control
time perspective: Prospective
measure: C Protein Reactive
time frame: at year 1
measure: blood inflammatory markers
time frame: at year 1
measure: C Protein Reactive
time frame: every year during 5 years
measure: blood inflammatory markers
time frame: every year during 5 years
arm group label: COPD
arm group label: Controls
Blood samples
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
minimum age: 40 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Principal Investigator
investigator affiliation: Centre Hospitalier Intercommunal Creteil
investigator full name: Pascal ANDUJAR
investigator title: Principal Investigator