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/NCT05963191</url>
    </required_header>
    <id_info>
      <org_study_id>SFED 156</org_study_id>
      <nct_id>NCT05963191</nct_id>
    </id_info>
    <brief_title>CAD-EYE System for the Detection of Neoplastic Lesions in Patients With Lynch Syndrome</brief_title>
    <acronym>CADLYNCH</acronym>
    <official_title>Evaluation of the CAD-EYE System for the Detection of Colorectal Neoplastic Lesions in Patients With Lynch Syndrome</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>PERROD Guillaume</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>French Society of Digestive Endoscopy</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>
        Lynch syndrome (LS) is the most common genetic predisposition syndrome for colorectal cancer&#xD;
        (CRC), responsible for around 2-4% of cancers. It is characterized by a pathogenic germline&#xD;
        mutation in one of the DNA mismatch repair genes (path_MMR) MLH1, MSH2, MSH6, PMS2 or a&#xD;
        deletion in the 3' region of the Epcam gene. Patients followed up for LS are at high risk of&#xD;
        developing CRC at an early age, and have a high cumulative CRC risk. In this context, CRC&#xD;
        screening by colonoscopy is of major importance, as it is associated with a reduction in both&#xD;
        CRC incidence and mortality.&#xD;
  &#xD;
        In France, the Institut National du Cancer (INCa) recommends colonoscopy with indigo carmine&#xD;
        chromoendoscopy (CE), as it is associated with a significant increase in the adenoma&#xD;
        detection rate (ADR) compared with white light. However, EC is not routinely performed in&#xD;
        clinical practice, as it is a time-consuming technique requiring a dedicated slot with a&#xD;
        trained operator.&#xD;
  &#xD;
        Recent years have seen the emergence of artificial intelligence techniques for real-time&#xD;
        polyp detection aids or CADe devices. These easy-to-use systems have shown very promising&#xD;
        results compared with high-definition (HD) white light. Indeed, data from the first&#xD;
        meta-analysis of 5 randomized controlled trials (4354 patients) confirmed a significantly&#xD;
        higher ADD in the CADe group than in the HD group (36.6% vs. 25.2%; 95% CI], 1.27-1.62; P &lt;&#xD;
        0.01; I2 Z 42%) 10. The CAD EYE system (Fujifilm) is a CADe device supporting both detection&#xD;
        (sensitivity &gt; 95%) and characterization of colonic polyps in real time.&#xD;
  &#xD;
        To date, artificial intelligence has never been evaluated for CRC screening in patients&#xD;
        followed up for LS. The aim of this work is to evaluate the effectiveness of the CAD EYE&#xD;
        system in this specific population. To this end, we intend to conduct a randomized,&#xD;
        controlled, non-inferiority trial comparing CAD EYE with CE in patients with LS.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2, 2023</start_date>
    <completion_date type="Anticipated">October 2, 2025</completion_date>
    <primary_completion_date type="Anticipated">October 2, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Diagnostic</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>to evaluate the effectiveness of the CAD EYE system in screening for neoplastic lesions in Lynch syndrome.</measure>
      <time_frame>Through study completion, an average of 2 years</time_frame>
      <description>Comparison of the adenoma detection rate (ADR) between the CAD-EYE group and the indigo carmin chromoendoscopy (CE) group (reference technique).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Detection rates of specific lesions</measure>
      <time_frame>Through study completion, an average of 2 years</time_frame>
      <description>Mean number of adenomas and serrated lesions per patient</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Diagnostic performance of CAD EYE</measure>
      <time_frame>Through study completion, an average of 2 years</time_frame>
      <description>Comparison of the diagnostic performance of CAD EYE assessed by specificity, negative predictive value and positive predictive value for the characterization (adenoma/hyperplastic) of colonic polyps with the CAD EYE automated detection system. The anatomopathology of polyps was taken as the diagnostic reference.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Rate of resect and discard strategy</measure>
      <time_frame>Through study completion, an average of 2 years</time_frame>
      <description>Evaluation of the feasibility of a &quot;resect and discard&quot; strategy in Lynch Syndrome. Retrospective analysis comparing CAD-EYE histological prediction vs. endoscopist prediction, using histological report as reference examination (Sensitivity and negative predictive value).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time of Colonoscopies</measure>
      <time_frame>Through study completion, an average of 2 years</time_frame>
      <description>Comparison of different procedure times between the 2 groups. Total procedure time will be defined as the time from endoscope insertion to extraction through the anus. Withdrawal time will be defined as the time spent on inspection, from the cecum to extraction of the endoscope through the anus, excluding the time required for polypectomy.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">272</enrollment>
    <condition>Lynch Syndrome</condition>
    <arm_group>
      <arm_group_label>CAD-EYE group: Colorectal cancer screening with CAD EYE colonoscopy</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The colonoscopy procedure for each patient will be no different from a conventional colonoscopy examination. In the CAD EYE group, descent is performed under white light, with the CAD EYE system switched on (device with CE mark). When polyps are detected, they are rigorously described and histological predictions of endoscopist and CAD EYE will be reported separately.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>CE group : Colorectal cancer screening with indigo carmine chromo colonoscopy</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>The colonoscopy procedure for each patient will be no different from a conventional colonoscopy examination. In the CE group, descent is performed under white light with indigo carmin chromoendoscopy (0.4%) applied through a catheter spray. When polyps are detected, they are rigorously described and histological prediction of the endoscopist reported.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Colorectal cancer screening with CAD EYE colonoscopy</intervention_name>
      <description>The colonoscopy procedure for each patient will be no different from a conventional colonoscopy examination. A colonoscopy is considered complete if the endoscope reaches the appendicular orifice or the terminal ileum. In line with recommendations, water lavage (using a lavage pump) and aspiration of food residues will be performed on ascent and/or descent to visualize the entire colonic mucosa.&#xD;
  In the CAD EYE group, descent is performed under white light, with the CAD EYE system switched on. When polyps are detected, they are rigorously described and histological predictions of endoscopist and CAD EYE will be reported separately. Then polyps will be removed by polypectomy or mucosectomy. Removed polyps are then sent for anatomopathological analysis.</description>
      <arm_group_label>CAD-EYE group: Colorectal cancer screening with CAD EYE colonoscopy</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Confirmed pathogenic mutation (path_MLH1, path_MSH2, path_MSH6, path_PMS2, path_EpCAM)&#xD;
  &#xD;
            -  Male or female of legal age at time of colonoscopy prescription.&#xD;
  &#xD;
            -  Patient agreeing to participate in the study&#xD;
  &#xD;
            -  Person affiliated with or benefiting from a social security scheme&#xD;
  &#xD;
            -  Free, informed and express consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patient undergoing total colectomy with ileoanal or ileosigmoid anastomosis&#xD;
  &#xD;
            -  Patient with a history of Crohn's disease or ulcerative colitis&#xD;
  &#xD;
            -  Patients with a known allergy or intolerance to polyethylene glycol and ascorbic acid.&#xD;
  &#xD;
            -  Patients unable to undergo fractionated colonic preparation&#xD;
  &#xD;
            -  Inadequate colonic preparation: Boston sub-score &lt;2 per segment&#xD;
  &#xD;
            -  Patient under guardianship or protected person&#xD;
  &#xD;
            -  Patient who does not understand French or cannot read&#xD;
  &#xD;
            -  Person not affiliated to a Social Security system.&#xD;
  &#xD;
            -  Pregnant women&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>90 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Guillaume Perrod, MD</last_name>
      <phone>+33 1 56 09 34 17</phone>
      <email>guillaume.perrod@aphp.fr</email>
    </overall_contact>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 10, 2023</study_first_submitted>
    <study_first_submitted_qc>July 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 18, 2023</last_update_submitted>
    <last_update_submitted_qc>July 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 27, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>French Society of Digestive Endoscopy</investigator_affiliation>
      <investigator_full_name>PERROD Guillaume</investigator_full_name>
      <investigator_title>Principal Investigator, Medical Doctor</investigator_title>
    </responsible_party>
    <keyword>Lynch Syndrome</keyword>
    <keyword>CAD EYE</keyword>
    <keyword>adenoma detection rate</keyword>
    <keyword>colorectal screening</keyword>
    <keyword>artificial intelligence</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Colorectal Neoplasms, Hereditary Nonpolyposis</mesh_term>
      <mesh_term>Syndrome</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/NCT05963191
  org study id: SFED 156
  nct id: NCT05963191
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Lynch syndrome (LS) is the most common genetic predisposition syndrome for colorectal cancer
        (CRC), responsible for around 2-4% of cancers. It is characterized by a pathogenic germline
        mutation in one of the DNA mismatch repair genes (path_MMR) MLH1, MSH2, MSH6, PMS2 or a
        deletion in the 3' region of the Epcam gene. Patients followed up for LS are at high risk of
        developing CRC at an early age, and have a high cumulative CRC risk. In this context, CRC
        screening by colonoscopy is of major importance, as it is associated with a reduction in both
        CRC incidence and mortality.
  
        In France, the Institut National du Cancer (INCa) recommends colonoscopy with indigo carmine
        chromoendoscopy (CE), as it is associated with a significant increase in the adenoma
        detection rate (ADR) compared with white light. However, EC is not routinely performed in
        clinical practice, as it is a time-consuming technique requiring a dedicated slot with a
        trained operator.
  
        Recent years have seen the emergence of artificial intelligence techniques for real-time
        polyp detection aids or CADe devices. These easy-to-use systems have shown very promising
        results compared with high-definition (HD) white light. Indeed, data from the first
        meta-analysis of 5 randomized controlled trials (4354 patients) confirmed a significantly
        higher ADD in the CADe group than in the HD group (36.6% vs. 25.2%; 95% CI], 1.27-1.62; P <
        0.01; I2 Z 42%) 10. The CAD EYE system (Fujifilm) is a CADe device supporting both detection
        (sensitivity > 95%) and characterization of colonic polyps in real time.
  
        To date, artificial intelligence has never been evaluated for CRC screening in patients
        followed up for LS. The aim of this work is to evaluate the effectiveness of the CAD EYE
        system in this specific population. To this end, we intend to conduct a randomized,
        controlled, non-inferiority trial comparing CAD EYE with CE in patients with LS.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Diagnostic
  masking: Single (Participant)
  measure: to evaluate the effectiveness of the CAD EYE system in screening for neoplastic lesions in Lynch syndrome.
  time frame: Through study completion, an average of 2 years
  description: Comparison of the adenoma detection rate (ADR) between the CAD-EYE group and the indigo carmin chromoendoscopy (CE) group (reference technique).
  measure: Detection rates of specific lesions
  time frame: Through study completion, an average of 2 years
  description: Mean number of adenomas and serrated lesions per patient
  measure: Diagnostic performance of CAD EYE
  time frame: Through study completion, an average of 2 years
  description: Comparison of the diagnostic performance of CAD EYE assessed by specificity, negative predictive value and positive predictive value for the characterization (adenoma/hyperplastic) of colonic polyps with the CAD EYE automated detection system. The anatomopathology of polyps was taken as the diagnostic reference.
  measure: Rate of resect and discard strategy
  time frame: Through study completion, an average of 2 years
  description: Evaluation of the feasibility of a "resect and discard" strategy in Lynch Syndrome. Retrospective analysis comparing CAD-EYE histological prediction vs. endoscopist prediction, using histological report as reference examination (Sensitivity and negative predictive value).
  measure: Time of Colonoscopies
  time frame: Through study completion, an average of 2 years
  description: Comparison of different procedure times between the 2 groups. Total procedure time will be defined as the time from endoscope insertion to extraction through the anus. Withdrawal time will be defined as the time spent on inspection, from the cecum to extraction of the endoscope through the anus, excluding the time required for polypectomy.
  arm group label: CAD-EYE group: Colorectal cancer screening with CAD EYE colonoscopy
  arm group type: Experimental
  description: The colonoscopy procedure for each patient will be no different from a conventional colonoscopy examination. In the CAD EYE group, descent is performed under white light, with the CAD EYE system switched on (device with CE mark). When polyps are detected, they are rigorously described and histological predictions of endoscopist and CAD EYE will be reported separately.
  arm group label: CE group : Colorectal cancer screening with indigo carmine chromo colonoscopy
  arm group type: No Intervention
  description: The colonoscopy procedure for each patient will be no different from a conventional colonoscopy examination. In the CE group, descent is performed under white light with indigo carmin chromoendoscopy (0.4%) applied through a catheter spray. When polyps are detected, they are rigorously described and histological prediction of the endoscopist reported.
  intervention type: Device
  intervention name: Colorectal cancer screening with CAD EYE colonoscopy
  description: The colonoscopy procedure for each patient will be no different from a conventional colonoscopy examination. A colonoscopy is considered complete if the endoscope reaches the appendicular orifice or the terminal ileum. In line with recommendations, water lavage (using a lavage pump) and aspiration of food residues will be performed on ascent and/or descent to visualize the entire colonic mucosa.
  In the CAD EYE group, descent is performed under white light, with the CAD EYE system switched on. When polyps are detected, they are rigorously described and histological predictions of endoscopist and CAD EYE will be reported separately. Then polyps will be removed by polypectomy or mucosectomy. Removed polyps are then sent for anatomopathological analysis.
  arm group label: CAD-EYE group: Colorectal cancer screening with CAD EYE colonoscopy
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 90 Years
  healthy volunteers: No
  last name: Guillaume Perrod, MD
  phone: +33 1 56 09 34 17
  email: guillaume.perrod@aphp.fr
  responsible party type: Sponsor-Investigator
  investigator affiliation: French Society of Digestive Endoscopy
  investigator full name: PERROD Guillaume
  investigator title: Principal Investigator, Medical Doctor
  mesh term: Colorectal Neoplasms, Hereditary Nonpolyposis
  mesh term: Syndrome