<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/NCT01687647</url>
  </required_header>
  <id_info>
    <org_study_id>2011-A01380-41</org_study_id>
    <secondary_id>PHRC11-221</secondary_id>
    <nct_id>NCT01687647</nct_id>
  </id_info>
  <brief_title>Sputum Cytometry Analysis in Lung Cancer Screening After Professional Asbestos Exposure</brief_title>
  <acronym>AMORCE-CBP</acronym>
  <official_title>Interest of Morphometric Analysis of Sputum Cytology for Lung Cancer Screening in Workers Highly Exposed to Asbestos - Exploratory Analysis of Biomarkers Predictive for Lung Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Caen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ministry of Health, France</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Caen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Workers exposed to asbestos are at high risk of lung cancer. Medical follow-up of this&#xD;
      population relies on repeated CT-scans which are more accurate for detection of peripheral&#xD;
      lesions, and expose to X-rays and to risk of false-positives. Analysis of sputum using&#xD;
      automate cytometry may be of interest in this population, alone or in combination with&#xD;
      CT-scan.&#xD;
&#xD;
      An ancillary study will evaluate the interest of blood predictive biomarkers.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date>September 2012</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">March 2015</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Screening</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Risk of false positive</measure>
    <time_frame>within 3 months</time_frame>
    <description>Ratio of false positives (RFP) for detection of lung cancer in reference to conventional cytology analysis of sputum</description>
  </primary_outcome>
  <primary_outcome>
    <measure>detection of lung cancer</measure>
    <time_frame>within 3 months</time_frame>
    <description>Ratio of sensitivities for detection of lung cancer in reference to conventionnal cytology analysis of sputum</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sensitivity for lung cancer detection compared with CT-scan</measure>
    <time_frame>within 3 months</time_frame>
    <description>Ratio of sensitivity (RSN) for lung cancer detection in reference with CT scan.&#xD;
Interest of the combination &quot;cytometry + CT-scan&quot; compared with CT-scan alone will also be evaluated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Specificity for detection of lung cancer</measure>
    <time_frame>within 3 months</time_frame>
    <description>Ratio of false positives (RFP) of automated cytometry analysis compared with CT-scan screening.&#xD;
The combination &quot;automated cytometry + CTscan&quot; will also be evaluated compared with CT scan alone.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Predictive Biomarkers</measure>
    <time_frame>Annually during a maximum of 5 years</time_frame>
    <description>Frequency of specific biomarkers at the time of screening. Links between lung cancer during 5 years of prospective follow-up.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Lung Neoplasms</condition>
  <arm_group>
    <arm_group_label>Screening</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Paired-design: low-dose CT scan, sputum sample and blood test will be performed on all subjects.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>low-dose CT-scan AND induced sputum sample AND blood test</intervention_name>
    <description>All subjects will receive a low-dose CT-scan, a blood test (ancillary study) and provide an induced sputum</description>
    <arm_group_label>Screening</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  High professional asbestos exposure&#xD;
&#xD;
          -  Member of a former cohort recruited between 2000 and 2006 in Caen, Rouen and Le Havre&#xD;
             (inclusion criteria: 50-75 years at the time of initial recruitment, high intermittent&#xD;
             asbestos exposure &gt;= 1 year, or high discontinuous asbestos exposure &gt;=10 years). All&#xD;
             the living members of the cohort will be contacted: a maximum of 1000 subjects is&#xD;
             expected, probably less.&#xD;
&#xD;
          -  Informed consent signed&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Personal history of lung cancer&#xD;
&#xD;
          -  Refusal of the study protocol&#xD;
&#xD;
          -  Uncontrolled asthma or lung failure&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>56 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lydia GUITTET, MD,PhD</last_name>
    <role>Study Director</role>
    <affiliation>Caen University Hospital, INSERM</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Caen University Hospital</name>
      <address>
        <city>Caen</city>
        <zip>14000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Le Havre Hospital</name>
      <address>
        <city>Le Havre</city>
        <zip>76600</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rouen University Hospital</name>
      <address>
        <city>Rouen</city>
        <zip>76031</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>April 2014</verification_date>
  <study_first_submitted>August 31, 2012</study_first_submitted>
  <study_first_submitted_qc>September 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2012</study_first_posted>
  <last_update_submitted>April 8, 2014</last_update_submitted>
  <last_update_submitted_qc>April 8, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 9, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Lung cancer screening</keyword>
  <keyword>Asbestos exposed workers</keyword>
  <keyword>Sputum analysis</keyword>
  <keyword>Automated cytometry</keyword>
  <keyword>Predictive biomarkers</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</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/NCT01687647
org study id: 2011-A01380-41
secondary id: PHRC11-221
nct id: NCT01687647
lead sponsor: 
collaborator: 
has dmc: No
Workers exposed to asbestos are at high risk of lung cancer. Medical follow-up of this
      population relies on repeated CT-scans which are more accurate for detection of peripheral
      lesions, and expose to X-rays and to risk of false-positives. Analysis of sputum using
      automate cytometry may be of interest in this population, alone or in combination with
      CT-scan.

      An ancillary study will evaluate the interest of blood predictive biomarkers.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Screening
masking: Double (Participant, Outcomes Assessor)
measure: Risk of false positive
time frame: within 3 months
description: Ratio of false positives (RFP) for detection of lung cancer in reference to conventional cytology analysis of sputum
measure: detection of lung cancer
time frame: within 3 months
description: Ratio of sensitivities for detection of lung cancer in reference to conventionnal cytology analysis of sputum
measure: Sensitivity for lung cancer detection compared with CT-scan
time frame: within 3 months
description: Ratio of sensitivity (RSN) for lung cancer detection in reference with CT scan.
Interest of the combination "cytometry + CT-scan" compared with CT-scan alone will also be evaluated.
measure: Specificity for detection of lung cancer
time frame: within 3 months
description: Ratio of false positives (RFP) of automated cytometry analysis compared with CT-scan screening.
The combination "automated cytometry + CTscan" will also be evaluated compared with CT scan alone.
measure: Predictive Biomarkers
time frame: Annually during a maximum of 5 years
description: Frequency of specific biomarkers at the time of screening. Links between lung cancer during 5 years of prospective follow-up.
arm group label: Screening
arm group type: Other
description: Paired-design: low-dose CT scan, sputum sample and blood test will be performed on all subjects.
intervention type: Other
intervention name: low-dose CT-scan AND induced sputum sample AND blood test
description: All subjects will receive a low-dose CT-scan, a blood test (ancillary study) and provide an induced sputum
arm group label: Screening
criteria: 
gender: All
minimum age: 56 Years
maximum age: N/A
healthy volunteers: No
last name: Lydia GUITTET, MD,PhD
role: Study Director
affiliation: Caen University Hospital, INSERM
facility: 
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Lung Neoplasms