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Artificial Intelligence to Implement Cost-saving Strategies for Colonoscopy Screening Based on in Vivo Prediction of Polyp Histology

RecruitingNAAges 40 Years - anyAllIstituto Clinico Humanitas
NCT06041945 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * All \>40 years-old patients undergoing colonoscopy for selected indications Exclusion Criteria: * patients with personal history of CRC, or IBD * patients affected with Lynch syndrome or Familiar Adenomatous Polyposis. * patients with inadequate bowel preparation (defined as Boston Bowel Preparation Scale \<2 in any colonic segment). * patients with previous colonic resection. * patients on antithrombotic therapy, precluding polyp resection. * patients who were not able or refused to give informed written consent.
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What it tests

  • Standard, high-definition colonoscopy with the use of CADe assistance
  • Standard, high-definition colonoscopy with the use of CADe/CADx assistance, no leave-in-situ
  • Standard, high-definition colonoscopy with the use of CADe/CADx assistance, leave-in-situ
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Where

2 sites
Istituto Clinico Humanitas
Rozzano, Italy
Istituto Clinico Humanitas
Rozzano, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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