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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorIstituto Clinico Humanitas

About this trial

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.

Eligibility criteria

Qualifiers

All >40 years-old patients undergoing colonoscopy for selected indications

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • 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

Treatment groups

1,800 Participants
are divided into 3 treatment groups

Sponsors and collaborators