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/NCT06020443</url>
    </required_header>
    <id_info>
      <org_study_id>GHR 1303</org_study_id>
      <secondary_id>2023-A00803-42</secondary_id>
      <nct_id>NCT06020443</nct_id>
    </id_info>
    <brief_title>Adherence to Lung Cancer Screening by Low-dose Thoracic CT in Haut-Rhin Department, France.</brief_title>
    <acronym>DECANPHAR</acronym>
    <official_title>Adherence to Lung Cancer Screening by Low-dose Thoracic CT in Haut-Rhin Department, France.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Groupe Hospitalier de la Region de Mulhouse et Sud Alsace</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Groupe Hospitalier de la Region de Mulhouse et Sud Alsace</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>
        The main objective of the study is to measure adherence to a lung cancer screening program&#xD;
        using low-dose thoracic CT.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Secondary objectives&#xD;
  &#xD;
          1. To evaluate patient compliance over the entire duration of the screening program&#xD;
  &#xD;
          2. To assess patient smoking cessation&#xD;
  &#xD;
          3. To describe radiation doses received during CT scans&#xD;
  &#xD;
          4. To identify organizational constraints for general practitioners&#xD;
  &#xD;
          5. To compare stages at diagnosis before and after implementation of screening program&#xD;
  &#xD;
        Conduct of research Eligible patients will be identified by general practitioners. Patients&#xD;
        included will require a low-dose thoracic CT scan to be performed by a radiologist of their&#xD;
        choice. Smoking cessation will be systematically proposed, and will be carried out by the&#xD;
        general practitioner or a tobaccologist.&#xD;
  &#xD;
        The radiation dose from thoracic CT scans should not exceed 100 mGy.cm Product Dose Length&#xD;
        (i.e. &lt; 1.5 mSv). Imaging reports will be forwarded to the general practitioner.&#xD;
  &#xD;
        If the first CT scan is negative (T0): a second scan will be scheduled 1 year later (T1). If&#xD;
        this second scan is also negative, in the absence of lung cancer risk factors other than&#xD;
        smoking, scans will then be performed every two years. In the presence of a risk factor for&#xD;
        lung cancer (other than tobacco), screening will remain annual.&#xD;
  &#xD;
        In the event of a result classified as uncertain: a follow-up scan is scheduled at 3 months ;&#xD;
        if the follow-up scan is negative, the next screening will be scheduled 1 year after this&#xD;
        follow-up scan. If the screening performed 1 year later is also negative, subsequent&#xD;
        screenings will be performed annually.&#xD;
  &#xD;
        In the event of a positive result: the general practitioner will refer the patient to a&#xD;
        pneumologist of his/her choice for further examinations; data from these additional&#xD;
        examinations will be collected.&#xD;
  &#xD;
        The screening protocol may evolve in line with recommendations issued by the French National&#xD;
        Authority for Health (HAS).&#xD;
  &#xD;
        For participants undergoing CT scan at the imaging department of Emile Muller hospital in&#xD;
        Mulhouse (GHRMSA), a blood sample will be collected (optional) for subsequent biomarker&#xD;
        assays.&#xD;
      </textblock>
    </detailed_description>
    <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 2024</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>
      <intervention_model_description>Low Dose chest CT Scan for Lung Cancer Screening</intervention_model_description>
      <primary_purpose>Diagnostic</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Rate of included patients having undergone the first screening scan</measure>
      <time_frame>T0</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Rate of patients who refused to participate in the screening program</measure>
      <time_frame>1 year</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Rate of included patients having completed CT scans at each stage of follow-up</measure>
      <time_frame>3 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of patients newly committed to smoking cessation during the screening period</measure>
      <time_frame>3 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Tobacco consumption</measure>
      <time_frame>3 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Radiation doses received at each CT scan</measure>
      <time_frame>3 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Organizational constraints of the screening program</measure>
      <time_frame>before starting the study</time_frame>
      <description>Organizational constraints of the screening program will be assessed on a subgroup of general practitioners by semi-structured interviews</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Stage at diagnosis (TNM classification) of patients with lung cancer</measure>
      <time_frame>3 years</time_frame>
      <description>The stages at diagnosis of patients with lung cancer included in the study will be compared with those of undetected patients (data from the Haut-Rhin Cancer Registry).</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">126</enrollment>
    <condition>High-Risk Cancer</condition>
    <condition>Lung Cancer</condition>
    <arm_group>
      <arm_group_label>Patients with a high risk of lung cancer</arm_group_label>
      <arm_group_type>Other</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Low Dose chest CT Scan for Lung Cancer Screening</intervention_name>
      <description>Low dose CT scans will be performed for three years</description>
      <arm_group_label>Patients with a high risk of lung cancer</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients aged 50 to 74 years&#xD;
  &#xD;
            -  Smoking OR having smoked (withdrawal of &lt;15 years): ≥15 cigarettes/day for ≥25 years&#xD;
               OR ≥10 cigarettes/day for ≥30 years&#xD;
  &#xD;
            -  Affiliated or beneficiary of a social security scheme&#xD;
  &#xD;
            -  Written informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Inability to walk up two flights of stairs without stopping&#xD;
  &#xD;
            -  BMI &gt; 35 kg/m²&#xD;
  &#xD;
            -  Recent chest CT scan &lt; 1 year&#xD;
  &#xD;
            -  Personal history of lung cancer &lt; 5 years or under treatment&#xD;
  &#xD;
            -  Personal history of cancer being monitored by chest CT scan&#xD;
  &#xD;
            -  Contraindication to lung cancer treatment or diagnostic investigations&#xD;
  &#xD;
            -  Current or recent respiratory symptoms immediately suggestive of lung cancer&#xD;
  &#xD;
            -  Pregnant or breast-feeding woman&#xD;
  &#xD;
            -  Person under court protection, guardianship or curatorship&#xD;
  &#xD;
            -  Person deprived of liberty by judicial or administrative decision.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>50 Years</minimum_age>
      <maximum_age>74 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Patrick Strentz, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>General Practioner, Colmar, France</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Didier Debieuvre, MD</last_name>
      <phone>+33389647032</phone>
      <email>debieuvred@ghrmsa.fr</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 28, 2023</study_first_submitted>
    <study_first_submitted_qc>August 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 31, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 31, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>screening</keyword>
    <keyword>low dose chest computed tomography</keyword>
    <keyword>lung cancer</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>
  
  
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/NCT06020443
  org study id: GHR 1303
  secondary id: 2023-A00803-42
  nct id: NCT06020443
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The main objective of the study is to measure adherence to a lung cancer screening program
        using low-dose thoracic CT.
  Secondary objectives
  
          1. To evaluate patient compliance over the entire duration of the screening program
  
          2. To assess patient smoking cessation
  
          3. To describe radiation doses received during CT scans
  
          4. To identify organizational constraints for general practitioners
  
          5. To compare stages at diagnosis before and after implementation of screening program
  
        Conduct of research Eligible patients will be identified by general practitioners. Patients
        included will require a low-dose thoracic CT scan to be performed by a radiologist of their
        choice. Smoking cessation will be systematically proposed, and will be carried out by the
        general practitioner or a tobaccologist.
  
        The radiation dose from thoracic CT scans should not exceed 100 mGy.cm Product Dose Length
        (i.e. < 1.5 mSv). Imaging reports will be forwarded to the general practitioner.
  
        If the first CT scan is negative (T0): a second scan will be scheduled 1 year later (T1). If
        this second scan is also negative, in the absence of lung cancer risk factors other than
        smoking, scans will then be performed every two years. In the presence of a risk factor for
        lung cancer (other than tobacco), screening will remain annual.
  
        In the event of a result classified as uncertain: a follow-up scan is scheduled at 3 months ;
        if the follow-up scan is negative, the next screening will be scheduled 1 year after this
        follow-up scan. If the screening performed 1 year later is also negative, subsequent
        screenings will be performed annually.
  
        In the event of a positive result: the general practitioner will refer the patient to a
        pneumologist of his/her choice for further examinations; data from these additional
        examinations will be collected.
  
        The screening protocol may evolve in line with recommendations issued by the French National
        Authority for Health (HAS).
  
        For participants undergoing CT scan at the imaging department of Emile Muller hospital in
        Mulhouse (GHRMSA), a blood sample will be collected (optional) for subsequent biomarker
        assays.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: Low Dose chest CT Scan for Lung Cancer Screening
  primary purpose: Diagnostic
  masking: None (Open Label)
  measure: Rate of included patients having undergone the first screening scan
  time frame: T0
  measure: Rate of patients who refused to participate in the screening program
  time frame: 1 year
  measure: Rate of included patients having completed CT scans at each stage of follow-up
  time frame: 3 years
  measure: Number of patients newly committed to smoking cessation during the screening period
  time frame: 3 years
  measure: Tobacco consumption
  time frame: 3 years
  measure: Radiation doses received at each CT scan
  time frame: 3 years
  measure: Organizational constraints of the screening program
  time frame: before starting the study
  description: Organizational constraints of the screening program will be assessed on a subgroup of general practitioners by semi-structured interviews
  measure: Stage at diagnosis (TNM classification) of patients with lung cancer
  time frame: 3 years
  description: The stages at diagnosis of patients with lung cancer included in the study will be compared with those of undetected patients (data from the Haut-Rhin Cancer Registry).
  arm group label: Patients with a high risk of lung cancer
  arm group type: Other
  intervention type: Procedure
  intervention name: Low Dose chest CT Scan for Lung Cancer Screening
  description: Low dose CT scans will be performed for three years
  arm group label: Patients with a high risk of lung cancer
  criteria: 
  gender: All
  minimum age: 50 Years
  maximum age: 74 Years
  healthy volunteers: No
  last name: Patrick Strentz, MD
  role: Principal Investigator
  affiliation: General Practioner, Colmar, France
  last name: Didier Debieuvre, MD
  phone: +33389647032
  email: debieuvred@ghrmsa.fr
  responsible party type: Sponsor
  mesh term: Lung Neoplasms
  sharing ipd: No