<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/NCT03803137</url>
  </required_header>
  <id_info>
    <org_study_id>2017081</org_study_id>
    <nct_id>NCT03803137</nct_id>
  </id_info>
  <brief_title>Volatil Organic Compounds in Exhaled Air and Sweat After Thoracic Surgery for Carcinological Resection</brief_title>
  <acronym>Onco-VOC</acronym>
  <official_title>Volatil Organic Compounds in Exhaled Air and Sweat After Thoracic Surgery for Carcinological Resection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hopital Foch</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hopital Foch</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>
      Bronchopulmonary cancer, with 39 000 new cases and 30 000 deaths per year, is a main issue in&#xD;
      public health in France. It is the leading cause of cancer death in France. A lot of progress&#xD;
      in medical care has been made, but surgery remains the most effective treatment, when it is&#xD;
      still possible. The goal is to detect and manage the lung cancer as early as possible.&#xD;
      Alongside screening strategies by annual thoracic scanner, new approaches with innovative&#xD;
      technologies open up for cancer detection and therapeutic follow-up.&#xD;
&#xD;
      The study of volatile organic compounds (VOC) detected in exhaled air or in sweat, is an&#xD;
      innovative research area for respiratory diseases. The volatolomic analysis can be done&#xD;
      either by the technique of the mass spectrometry which allows the identification of each VOC&#xD;
      in the exhaled air or by the technique of electronic nose, simpler and faster, which provides&#xD;
      an idea of the general profile of the VOC without identifying them. The VOC have shown their&#xD;
      interest in some situations, such as diagnostic or prognostic tool in patients followed for&#xD;
      thoracic tumorous pathology or bronchial or pulmonary vascular diseases.&#xD;
&#xD;
      The composition of VOC in exhaled air and sweat is altered in patients with lung cancer. The&#xD;
      VOC analysis and their variation could be used particularly in the follow-up of patients&#xD;
      treated for lung cancer.&#xD;
&#xD;
      The purpose of this clinical research is to identify the VOCs related to lung cancers by&#xD;
      comparing the VOC profiles in exhaled air and in sweat from patients diagnosed with localized&#xD;
      lung cancer before and after resection surgery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 20, 2018</start_date>
  <completion_date type="Anticipated">September 2021</completion_date>
  <primary_completion_date type="Anticipated">September 2021</primary_completion_date>
  <phase>N/A</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Comparison of Volatil Organic Compound (VOC) profiles by mass spectrometry</measure>
    <time_frame>change from baseline profiles at 2 month post-surgery</time_frame>
    <description>Comparison of variation in Volatil Organic Compound (VOC) profiles in exhaled air of patients before and after surgery. The VOC will be identified by their molecular mass (by the mass spectrometry)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Comparison of Volatil Organic Compound (VOC) profiles in by electronic noses</measure>
    <time_frame>change from baseline profiles at 2 month post-surgery</time_frame>
    <description>Comparison of variation in Volatil Organic Compound (VOC) profiles in exhaled air of patients before and after surgery. The VOC will be identified by the sensor deflection (by the electronic noses).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Comparison of Volatil Organic Compound (VOC) profiles in sweat</measure>
    <time_frame>30 days before the surgery and 45 to 75 days after surgery</time_frame>
    <description>Comparison of Volatil Organic Compound (VOC) profiles in sweat of patients before and after surgery. The VOC will be identified by their molecular mass (by the mass spectrometry).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Variation of Volatil Organic Compound (VOC) and relapse rate</measure>
    <time_frame>30 days before the surgery, 45 to 75 days after surgery and 2 years</time_frame>
    <description>Correlation between the variation of Volatil Organic Compound (VOC) before-after surgery and relapse rate at 2 years</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between Volatil Organic Compound (VOC) profiles and relapse rate</measure>
    <time_frame>2 months and 2 years after surgery</time_frame>
    <description>Correlation between the Volatil Organic Compound (VOC) profiles 2 months after the surgery and relapse rate at 2 years</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of Volatil Organic Compound (VOC) profiles in exhaled air and tumoral lung tissue</measure>
    <time_frame>30 days before the surgery, day of surgery and 45 to 75 days after surgery</time_frame>
    <description>Comparison of Volatil Organic Compound (VOC) profiles in exhaled air of patients and those released ex-vivo by the tumoral lung tissue. The VOC will be identified by their molecular mass (by the mass spectrometry).</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Lung Cancer, Non-small Cell</condition>
  <arm_group>
    <arm_group_label>VOC analysis</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>VOC analysis in exhaled air and sweat in patients with thoracic surgery for carcinological resection</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>VOC analysis</intervention_name>
    <description>VOC analysis in exhaled air with e-noses and mass spectrometry</description>
    <arm_group_label>VOC analysis</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient aged ≥ 18 years old&#xD;
&#xD;
          -  Patient with non-small cell lung cancer&#xD;
&#xD;
          -  Operable grade I or II&#xD;
&#xD;
          -  No specific treatment before surgery (radiotherapy, chemotherapy or targeted therapy)&#xD;
&#xD;
          -  Patient with healthcare insurance&#xD;
&#xD;
        Non Inclusion Criteria:&#xD;
&#xD;
          -  Treatment with radiotherapy, chemotherapy, or neoadjuvant cancer targeted therapy&#xD;
             before thoracic surgery&#xD;
&#xD;
          -  Patient with oxygen therapy or invasive ventilation&#xD;
&#xD;
          -  Patient unable to perform a slow vital capacity&#xD;
&#xD;
          -  Dermatological therapy interfering with sweat collection (psoriasis, irritant&#xD;
             dermatitis, for instance)&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Patient deprived of liberty by judicial or administrative decision&#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>Philippe Devillier</last_name>
    <role>Principal Investigator</role>
    <affiliation>Pneumology department</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Elisabeth Hullier-Ammar</last_name>
    <phone>+33 1 46 25 11 75</phone>
    <email>drci-promotion@hopital-foch.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hôpital Foch</name>
      <address>
        <city>Suresnes</city>
        <zip>92150</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Philippe Devillier</last_name>
      <phone>33 1 46 25 27 91</phone>
      <email>p.devillier@hopital-foch.com</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>October 5, 2018</study_first_submitted>
  <study_first_submitted_qc>January 10, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 14, 2019</study_first_posted>
  <last_update_submitted>December 17, 2020</last_update_submitted>
  <last_update_submitted_qc>December 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma, Non-Small-Cell Lung</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03803137
org study id: 2017081
nct id: NCT03803137
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Bronchopulmonary cancer, with 39 000 new cases and 30 000 deaths per year, is a main issue in
      public health in France. It is the leading cause of cancer death in France. A lot of progress
      in medical care has been made, but surgery remains the most effective treatment, when it is
      still possible. The goal is to detect and manage the lung cancer as early as possible.
      Alongside screening strategies by annual thoracic scanner, new approaches with innovative
      technologies open up for cancer detection and therapeutic follow-up.

      The study of volatile organic compounds (VOC) detected in exhaled air or in sweat, is an
      innovative research area for respiratory diseases. The volatolomic analysis can be done
      either by the technique of the mass spectrometry which allows the identification of each VOC
      in the exhaled air or by the technique of electronic nose, simpler and faster, which provides
      an idea of the general profile of the VOC without identifying them. The VOC have shown their
      interest in some situations, such as diagnostic or prognostic tool in patients followed for
      thoracic tumorous pathology or bronchial or pulmonary vascular diseases.

      The composition of VOC in exhaled air and sweat is altered in patients with lung cancer. The
      VOC analysis and their variation could be used particularly in the follow-up of patients
      treated for lung cancer.

      The purpose of this clinical research is to identify the VOCs related to lung cancers by
      comparing the VOC profiles in exhaled air and in sweat from patients diagnosed with localized
      lung cancer before and after resection surgery.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Comparison of Volatil Organic Compound (VOC) profiles by mass spectrometry
time frame: change from baseline profiles at 2 month post-surgery
description: Comparison of variation in Volatil Organic Compound (VOC) profiles in exhaled air of patients before and after surgery. The VOC will be identified by their molecular mass (by the mass spectrometry)
measure: Comparison of Volatil Organic Compound (VOC) profiles in by electronic noses
time frame: change from baseline profiles at 2 month post-surgery
description: Comparison of variation in Volatil Organic Compound (VOC) profiles in exhaled air of patients before and after surgery. The VOC will be identified by the sensor deflection (by the electronic noses).
measure: Comparison of Volatil Organic Compound (VOC) profiles in sweat
time frame: 30 days before the surgery and 45 to 75 days after surgery
description: Comparison of Volatil Organic Compound (VOC) profiles in sweat of patients before and after surgery. The VOC will be identified by their molecular mass (by the mass spectrometry).
measure: Variation of Volatil Organic Compound (VOC) and relapse rate
time frame: 30 days before the surgery, 45 to 75 days after surgery and 2 years
description: Correlation between the variation of Volatil Organic Compound (VOC) before-after surgery and relapse rate at 2 years
measure: Correlation between Volatil Organic Compound (VOC) profiles and relapse rate
time frame: 2 months and 2 years after surgery
description: Correlation between the Volatil Organic Compound (VOC) profiles 2 months after the surgery and relapse rate at 2 years
measure: Comparison of Volatil Organic Compound (VOC) profiles in exhaled air and tumoral lung tissue
time frame: 30 days before the surgery, day of surgery and 45 to 75 days after surgery
description: Comparison of Volatil Organic Compound (VOC) profiles in exhaled air of patients and those released ex-vivo by the tumoral lung tissue. The VOC will be identified by their molecular mass (by the mass spectrometry).
arm group label: VOC analysis
arm group type: Experimental
description: VOC analysis in exhaled air and sweat in patients with thoracic surgery for carcinological resection
intervention type: Other
intervention name: VOC analysis
description: VOC analysis in exhaled air with e-noses and mass spectrometry
arm group label: VOC analysis
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Philippe Devillier
role: Principal Investigator
affiliation: Pneumology department
last name: Elisabeth Hullier-Ammar
phone: +33 1 46 25 11 75
email: drci-promotion@hopital-foch.com
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Carcinoma, Non-Small-Cell Lung
sharing ipd: Undecided