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RECRUITINGINTERVENTIONAL

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

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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.

Who May Be Eligible (Plain English)

Who May Qualify: - All \>40 years-old patients undergoing colonoscopy for selected indications Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DEVICE

Standard, high-definition colonoscopy with the use of CADe assistance

All detected polyps regardless of size and optical diagnosis will be resected and sent to pathology.

DEVICE

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

All detected polyps regardless of size and optical diagnosis will be resected and sent to pathology.

DEVICE

Standard, high-definition colonoscopy with the use of CADe/CADx assistance, leave-in-situ

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.

Locations (2)

Istituto Clinico Humanitas
Rozzano, Milano, Italy
Istituto Clinico Humanitas
Rozzano, Milano, Italy