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/NCT06041945</url>
    </required_header>
    <id_info>
      <org_study_id>SAVE study</org_study_id>
      <nct_id>NCT06041945</nct_id>
    </id_info>
    <brief_title>Artificial Intelligence to Implement Cost-saving Strategies for Colonoscopy Screening Based on in Vivo Prediction of Polyp Histology</brief_title>
    <acronym>SAVE</acronym>
    <official_title>Saving by Artificial Intelligence for Virtual Endoscopy Biopsy Artificial Intelligence to Implement Cost-saving Strategies for Colonoscopy Screening Based on in Vivo Prediction of Polyp Histology</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Istituto Clinico Humanitas</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Istituto Clinico Humanitas</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>
        This three parallel-arms, randomized, multicenter trial is aimed at investigating the value&#xD;
        of AI-assisted optical biopsy for differentiating between neoplastic and non-neoplastic&#xD;
        polyps which will lead to the implementation of cost-saving strategies in screening programs.&#xD;
        A cost-effectiveness analyses with the use of modern trial emulation analyses of large&#xD;
        observational and clinical trial datasets and real-cost data will be conducted. To improve&#xD;
        personalized treatment with a novel colonoscopy CADx risk-prediction tool, the investigators&#xD;
        will even develop a novel deep learning algorithm for the optical biopsy of the alternative&#xD;
        pathway of colorectal cancer carcinogenesis, namely the serrated pathway and develop&#xD;
        cost-effectiveness models of AI-assisted optical biopsy in colorectal cancer screening that&#xD;
        provides reliable information to identify cancer risk regardless of physicians' skill.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 13, 2023</start_date>
    <completion_date type="Anticipated">September 1, 2027</completion_date>
    <primary_completion_date type="Anticipated">September 1, 2027</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>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Non-inferiority in Adenoma Detection Rate</measure>
      <time_frame>4 years</time_frame>
      <description>Non-inferiority in the Adenoma Detection Rate, defined as the proportion of participants with at least one adenoma (per-patient analysis) in the three arms, when adopting a cost-saving leave-in-situ strategy for non-neoplastic rectosigmoid diminutive polyps.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Negative Predictive Value for colorectal neoplasia</measure>
      <time_frame>4 years</time_frame>
      <description>Negative Predictive Value for colorectal neoplasia when adopting a leave-in-situ strategy for rectosigmoid diminutive polyps based on the use of Artificial Intelligence.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Concordance between post-polypectomy surveillance and when adopting a leave-in-situ strategy</measure>
      <time_frame>4 years</time_frame>
      <description>Concordance between post-polypectomy surveillance based on strategies based on optical diagnosis with Artificial Intelligence and those based on histology, and when adopting a leave-in-situ strategy for colorectal diminutive polyps based on the use of Artificial Intelligence</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in the cost of polypectomy and histology in screening programs</measure>
      <time_frame>4 years</time_frame>
      <description>Change in the cost of polypectomy and histology in screening programs, when implementing strategies based on Artificial Intelligence-based optical biopsy, without changes in benefit related with detection of colorectal neoplasia</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">1800</enrollment>
    <condition>Colonic Neoplasms</condition>
    <arm_group>
      <arm_group_label>Standard Arm CADe</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Standard, high-definition colonoscopy with the use of CADe assistance (GI-GENIUS, Medtronic; CAD-EYE, Fujifilm; WISE VISION ,NEC). All detected polyps regardless of size and optical diagnosis will be resected and sent to pathology.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Standard Arm CADe/CADx</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Standard, high-definition colonoscopy with the use of CADe/CADx assistance (GI-GENIUS, Medtronic; CAD-EYE, Fujifilm; WISE VISION ,NEC). All detected polyps regardless of size and optical diagnosis will be resected and sent to pathology.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Leave-In-Situ Arm</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Standard, high-definition colonoscopy with the use of CADe/CADx assistance (GI-GENIUS, Medtronic; CAD-EYE, Fujifilm; WISE VISION, NEC).&#xD;
  Polyps will be left in situ if diminutive (≤5 mm) in size, located in the rectum or sigma and optically diagnosed by the endoscopist using the system to be hyperplastic with high confidence, otherwise resected and sent to pathology.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Standard, high-definition colonoscopy with the use of CADe assistance</intervention_name>
      <description>All detected polyps regardless of size and optical diagnosis will be resected and sent to pathology.</description>
      <arm_group_label>Standard Arm CADe</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Standard, high-definition colonoscopy with the use of CADe/CADx assistance, no leave-in-situ</intervention_name>
      <description>All detected polyps regardless of size and optical diagnosis will be resected and sent to pathology.</description>
      <arm_group_label>Standard Arm CADe/CADx</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Standard, high-definition colonoscopy with the use of CADe/CADx assistance, leave-in-situ</intervention_name>
      <description>Polyps will be left in situ if diminutive (≤5 mm) in size, located in the rectum or sigma and optically diagnosed by the endoscopist using the system to be hyperplastic with high confidence, otherwise resected and sent to pathology.</description>
      <arm_group_label>Leave-In-Situ Arm</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  All &gt;40 years-old patients undergoing colonoscopy for selected indications&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  patients with personal history of CRC, or IBD&#xD;
  &#xD;
            -  patients affected with Lynch syndrome or Familiar Adenomatous Polyposis.&#xD;
  &#xD;
            -  patients with inadequate bowel preparation (defined as Boston Bowel Preparation Scale&#xD;
               &lt;2 in any colonic segment).&#xD;
  &#xD;
            -  patients with previous colonic resection.&#xD;
  &#xD;
            -  patients on antithrombotic therapy, precluding polyp resection.&#xD;
  &#xD;
            -  patients who were not able or refused to give informed written consent.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>40 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Cesare Hassan</last_name>
      <phone>02-82247385</phone>
      <email>cesare.hassan@hunimed.eu</email>
    </overall_contact>
    <location>
      <facility>
        <name>Istituto Clinico Humanitas</name>
        <address>
          <city>Rozzano</city>
          <state>Milano</state>
          <zip>20089</zip>
          <country>Italy</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Italy</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 4, 2023</study_first_submitted>
    <study_first_submitted_qc>September 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 18, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 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>Colonic Neoplasms</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/NCT06041945
  org study id: SAVE study
  nct id: NCT06041945
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This three parallel-arms, randomized, multicenter trial is aimed at investigating the value
        of AI-assisted optical biopsy for differentiating between neoplastic and non-neoplastic
        polyps which will lead to the implementation of cost-saving strategies in screening programs.
        A cost-effectiveness analyses with the use of modern trial emulation analyses of large
        observational and clinical trial datasets and real-cost data will be conducted. To improve
        personalized treatment with a novel colonoscopy CADx risk-prediction tool, the investigators
        will even develop a novel deep learning algorithm for the optical biopsy of the alternative
        pathway of colorectal cancer carcinogenesis, namely the serrated pathway and develop
        cost-effectiveness models of AI-assisted optical biopsy in colorectal cancer screening that
        provides reliable information to identify cancer risk regardless of physicians' skill.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Non-inferiority in Adenoma Detection Rate
  time frame: 4 years
  description: Non-inferiority in the Adenoma Detection Rate, defined as the proportion of participants with at least one adenoma (per-patient analysis) in the three arms, when adopting a cost-saving leave-in-situ strategy for non-neoplastic rectosigmoid diminutive polyps.
  measure: Negative Predictive Value for colorectal neoplasia
  time frame: 4 years
  description: Negative Predictive Value for colorectal neoplasia when adopting a leave-in-situ strategy for rectosigmoid diminutive polyps based on the use of Artificial Intelligence.
  measure: Concordance between post-polypectomy surveillance and when adopting a leave-in-situ strategy
  time frame: 4 years
  description: Concordance between post-polypectomy surveillance based on strategies based on optical diagnosis with Artificial Intelligence and those based on histology, and when adopting a leave-in-situ strategy for colorectal diminutive polyps based on the use of Artificial Intelligence
  measure: Change in the cost of polypectomy and histology in screening programs
  time frame: 4 years
  description: Change in the cost of polypectomy and histology in screening programs, when implementing strategies based on Artificial Intelligence-based optical biopsy, without changes in benefit related with detection of colorectal neoplasia
  arm group label: Standard Arm CADe
  arm group type: Active Comparator
  description: Standard, high-definition colonoscopy with the use of CADe assistance (GI-GENIUS, Medtronic; CAD-EYE, Fujifilm; WISE VISION ,NEC). All detected polyps regardless of size and optical diagnosis will be resected and sent to pathology.
  arm group label: Standard Arm CADe/CADx
  arm group type: Active Comparator
  description: Standard, high-definition colonoscopy with the use of CADe/CADx assistance (GI-GENIUS, Medtronic; CAD-EYE, Fujifilm; WISE VISION ,NEC). All detected polyps regardless of size and optical diagnosis will be resected and sent to pathology.
  arm group label: Leave-In-Situ Arm
  arm group type: Experimental
  description: Standard, high-definition colonoscopy with the use of CADe/CADx assistance (GI-GENIUS, Medtronic; CAD-EYE, Fujifilm; WISE VISION, NEC).
  Polyps will be left in situ if diminutive (≤5 mm) in size, located in the rectum or sigma and optically diagnosed by the endoscopist using the system to be hyperplastic with high confidence, otherwise resected and sent to pathology.
  intervention type: Device
  intervention name: Standard, high-definition colonoscopy with the use of CADe assistance
  description: All detected polyps regardless of size and optical diagnosis will be resected and sent to pathology.
  arm group label: Standard Arm CADe
  intervention type: Device
  intervention name: Standard, high-definition colonoscopy with the use of CADe/CADx assistance, no leave-in-situ
  description: All detected polyps regardless of size and optical diagnosis will be resected and sent to pathology.
  arm group label: Standard Arm CADe/CADx
  intervention type: Device
  intervention name: Standard, high-definition colonoscopy with the use of CADe/CADx assistance, leave-in-situ
  description: Polyps will be left in situ if diminutive (≤5 mm) in size, located in the rectum or sigma and optically diagnosed by the endoscopist using the system to be hyperplastic with high confidence, otherwise resected and sent to pathology.
  arm group label: Leave-In-Situ Arm
  criteria: 
  gender: All
  minimum age: 40 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Cesare Hassan
  phone: 02-82247385
  email: cesare.hassan@hunimed.eu
  facility: 
  country: Italy
  responsible party type: Sponsor
  mesh term: Colonic Neoplasms