<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/NCT03250390</url>
  </required_header>
  <id_info>
    <org_study_id>2017_05</org_study_id>
    <secondary_id>2017-A00932-51</secondary_id>
    <secondary_id>PHRCI_2016</secondary_id>
    <nct_id>NCT03250390</nct_id>
  </id_info>
  <brief_title>Breath Analysis to Diagnose Lung Cancer</brief_title>
  <acronym>CATOCOV</acronym>
  <official_title>Analysis of Volatile Organic Compounds in Exhaled Air as a Diagnostic Tool for Thoracic Cancers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Lille</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Institut National de Recherche en Informatique et en Automatique</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Institut Pasteur de Lille</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Institut MinesTelecom (IMT)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Lille</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>
      Determination of volatile organic compounds to discriminate patients with lung cancer from&#xD;
      healthy smokers and non-smokers healthy subjects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">April 29, 2019</start_date>
  <completion_date type="Anticipated">April 29, 2023</completion_date>
  <primary_completion_date type="Anticipated">April 29, 2023</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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Discriminating power of VOCs</measure>
    <time_frame>34 months</time_frame>
    <description>Discriminating power of VOCs using discriminant analyzes using innovative data mining methods based on multi-objective combinatorial optimization.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">2000</enrollment>
  <condition>Lung Cancer</condition>
  <arm_group>
    <arm_group_label>patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with bronchopulmonary cancer who have not yet received therapeutic treatment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>controls</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The controls consisted of 2 groups: smokers and non-smokers.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Collection of volatile organic compounds during exhalation</intervention_name>
    <description>The volatile organic compounds (VOCs) are collected in sorbents at rest and at the end of exhalation according to the concentration of carbon dioxide using ReCIVA breath sampler.&#xD;
The identification of the VOCs will be done by chromatography (Gas Chromatography Mass Spectrometry GC-MS)</description>
    <arm_group_label>controls</arm_group_label>
    <arm_group_label>patients</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with histologically proven lung cancer&#xD;
&#xD;
        Controls:&#xD;
&#xD;
          -  healthy smoker or non-smoker subjects&#xD;
&#xD;
          -  without respiratory diseases excepted chronic obstructive pulmonary disease.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  history of cancer other than lung cancer within 5 years before inclusion&#xD;
&#xD;
          -  oral or facial malformation&#xD;
&#xD;
          -  incomprehension of maneuvers for the collection&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sébastien Hulo, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Lille</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sébastien Hulo, MD</last_name>
    <phone>3.20.44.52.85</phone>
    <phone_ext>+33</phone_ext>
    <email>sebastien.hulo@chru-lille.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Institut Pasteur - Centre de Prévention et d'Education à la Santé (CPES)</name>
      <address>
        <city>Lille</city>
        <zip>59000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hôpital Calmette, CHU</name>
      <address>
        <city>Lille</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Hulo Sébastien, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hopital Victor Provo</name>
      <address>
        <city>Roubaix</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier de Saint Quentin</name>
      <address>
        <city>Saint-Quentin</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Chu Amiens Salouël</name>
      <address>
        <city>Salouël</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Ch Seclin - Seclin</name>
      <address>
        <city>Seclin</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Cyrielle Jardin, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Clinique Teissier</name>
      <address>
        <city>Valenciennes</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Thomas GEY, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>August 7, 2017</study_first_submitted>
  <study_first_submitted_qc>August 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 15, 2017</study_first_posted>
  <last_update_submitted>November 7, 2022</last_update_submitted>
  <last_update_submitted_qc>November 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 8, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Lung cancer</keyword>
  <keyword>diagnosis</keyword>
  <keyword>volatile organic compounds</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</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/NCT03250390
org study id: 2017_05
secondary id: 2017-A00932-51
secondary id: PHRCI_2016
nct id: NCT03250390
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Determination of volatile organic compounds to discriminate patients with lung cancer from
      healthy smokers and non-smokers healthy subjects.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Discriminating power of VOCs
time frame: 34 months
description: Discriminating power of VOCs using discriminant analyzes using innovative data mining methods based on multi-objective combinatorial optimization.
arm group label: patients
arm group type: Experimental
description: Patients with bronchopulmonary cancer who have not yet received therapeutic treatment.
arm group label: controls
arm group type: Active Comparator
description: The controls consisted of 2 groups: smokers and non-smokers.
intervention type: Device
intervention name: Collection of volatile organic compounds during exhalation
description: The volatile organic compounds (VOCs) are collected in sorbents at rest and at the end of exhalation according to the concentration of carbon dioxide using ReCIVA breath sampler.
The identification of the VOCs will be done by chromatography (Gas Chromatography Mass Spectrometry GC-MS)
arm group label: controls
arm group label: patients
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sébastien Hulo, MD
role: Principal Investigator
affiliation: University Hospital, Lille
last name: Sébastien Hulo, MD
phone: 3.20.44.52.85
phone ext: +33
email: sebastien.hulo@chru-lille.fr
facility: 
status: Recruiting
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
country: France
responsible party type: Sponsor
mesh term: Lung Neoplasms
sharing ipd: No