xml: <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/NCT05985330</url>
    </required_header>
    <id_info>
      <org_study_id>GEORGES 2022</org_study_id>
      <nct_id>NCT05985330</nct_id>
    </id_info>
    <brief_title>Pilot Study of the Contribution of Fractional Exhaled Nitric Oxide as a Prognostic Marker of Response to Anti-PD-L1 Immunotherapy in Non-small Cell Lung Cancer</brief_title>
    <acronym>FENOTYPE</acronym>
    <official_title>Pilot Study of the Contribution of Fractional Exhaled Nitric Oxide as a Prognostic Marker of Response to Anti-PD-L1 Immunotherapy in Non-small Cell Lung Cancer</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Centre Hospitalier Universitaire Dijon</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Centre Hospitalier Universitaire Dijon</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Based on the use of the patient's natural defences, immunotherapy mobilizes the immune system&#xD;
        to recognize and destroy cancer cells, and it has revolutionized the treatment of lung&#xD;
        cancer.&#xD;
  &#xD;
        However, the effectiveness of immunotherapy varies from patient to patient. At present, we&#xD;
        have no weak markers to predict with certainty the efficacy of immunotherapy treatment in a&#xD;
        given individual.&#xD;
  &#xD;
        Current scientific data identifies a number of molecules produced by the cancer cells and&#xD;
        their environment which can be detected by various means (blood tests, breath analysis,&#xD;
        etc.).&#xD;
  &#xD;
        The aim of this study is to understand whether the amount of nitric oxide (NO) present in the&#xD;
        breath is a more accurate predictor of response to immunotherapy.&#xD;
  &#xD;
        Participation in this study involves breath testing (to measure FeNO (Fractional exhaled&#xD;
        Nitric Oxide)) before receiving the first infusion of immunotherapy, and at the follow-up&#xD;
        visit after the 4th course of immunotherapy.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">September 2026</completion_date>
    <primary_completion_date type="Anticipated">September 2026</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Response to immunotherapy by CT scan</measure>
      <time_frame>after 4 courses of immunotherapy, an average of 9 weeks</time_frame>
      <description>Evaluation according to RECIST criteria by comparing FeNO levels between patients responding and not responding to immunotherapy.</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">56</enrollment>
    <condition>Metastatic Non-small Cell Lung Cancer</condition>
    <arm_group>
      <arm_group_label>Patients</arm_group_label>
      <description>Patients with metastatic non-small-cell lung cancer</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Measurement of FeNO</intervention_name>
      <description>Before the first immunotherapy infusion and at the follow-up visit after the 4th course of immunotherapy</description>
      <arm_group_label>Patients</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with metastatic non-small-cell lung cancer requiring immunotherapy alone&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients with metastatic NSCLC&#xD;
  &#xD;
            -  Patient not previously treated&#xD;
  &#xD;
            -  PD-L1 tumor expression &gt; 50%, to be treated with immunotherapy alone after validation&#xD;
               by a multidisciplinary consultation meeting.&#xD;
  &#xD;
            -  Patients over 18 years of age&#xD;
  &#xD;
            -  Patient having given his/her non-opposition&#xD;
  &#xD;
            -  Patient who speaks and reads French&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients previously treated for NSCLC&#xD;
  &#xD;
            -  Patient with oncogene addiction or a first-line targetable rearrangement&#xD;
  &#xD;
            -  Patient not suitable for immunotherapy alone&#xD;
  &#xD;
            -  Patient having received corticosteroid treatment in the 15 days prior to FeNO.&#xD;
  &#xD;
            -  Patient on inhaled corticosteroid at time of inclusion.&#xD;
  &#xD;
            -  Blood eosinophilia &gt; 500 /mm3&#xD;
  &#xD;
            -  Patient on 24-hour oxygen therapy&#xD;
  &#xD;
            -  Contraindication to immunotherapy&#xD;
  &#xD;
            -  Inability to perform FeNO measurement manoeuvres&#xD;
  &#xD;
            -  Pregnant, parturient or breast-feeding women&#xD;
  &#xD;
            -  Person under judicial protection (curatorship, guardianship)&#xD;
  &#xD;
            -  Person subject to limited judicial protection&#xD;
  &#xD;
            -  Adult unable to express their non-opposition&#xD;
  &#xD;
            -  Patient refusing to participate in the study&#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_contact>
      <last_name>Marjolaine GEORGES</last_name>
      <phone>03.80.29.37.72</phone>
      <email>marjolaine.georges@chu-dijon.fr</email>
    </overall_contact>
    <location>
      <facility>
        <name>Chu Dijon Bourgogne</name>
        <address>
          <city>Dijon</city>
          <zip>21000</zip>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Marjolaine GEORGES</last_name>
        <phone>03.80.29.37.72</phone>
        <email>marjolaine.georges@chu-dijon.fr</email>
      </contact>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 24, 2023</study_first_submitted>
    <study_first_submitted_qc>August 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 8, 2023</last_update_submitted>
    <last_update_submitted_qc>August 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</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>Lung Neoplasms</mesh_term>
      <mesh_term>Carcinoma, Non-Small-Cell Lung</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05985330
  org study id: GEORGES 2022
  nct id: NCT05985330
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Based on the use of the patient's natural defences, immunotherapy mobilizes the immune system
        to recognize and destroy cancer cells, and it has revolutionized the treatment of lung
        cancer.
  
        However, the effectiveness of immunotherapy varies from patient to patient. At present, we
        have no weak markers to predict with certainty the efficacy of immunotherapy treatment in a
        given individual.
  
        Current scientific data identifies a number of molecules produced by the cancer cells and
        their environment which can be detected by various means (blood tests, breath analysis,
        etc.).
  
        The aim of this study is to understand whether the amount of nitric oxide (NO) present in the
        breath is a more accurate predictor of response to immunotherapy.
  
        Participation in this study involves breath testing (to measure FeNO (Fractional exhaled
        Nitric Oxide)) before receiving the first infusion of immunotherapy, and at the follow-up
        visit after the 4th course of immunotherapy.
  observational model: Cohort
  time perspective: Prospective
  measure: Response to immunotherapy by CT scan
  time frame: after 4 courses of immunotherapy, an average of 9 weeks
  description: Evaluation according to RECIST criteria by comparing FeNO levels between patients responding and not responding to immunotherapy.
  arm group label: Patients
  description: Patients with metastatic non-small-cell lung cancer
  intervention type: Other
  intervention name: Measurement of FeNO
  description: Before the first immunotherapy infusion and at the follow-up visit after the 4th course of immunotherapy
  arm group label: Patients
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Marjolaine GEORGES
  phone: 03.80.29.37.72
  email: marjolaine.georges@chu-dijon.fr
  facility: 
  contact: 
  country: France
  responsible party type: Sponsor
  mesh term: Lung Neoplasms
  mesh term: Carcinoma, Non-Small-Cell Lung