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Clinical Trial Summary

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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT06041945
Study type Interventional
Source Istituto Clinico Humanitas
Contact Cesare Hassan
Phone 02-82247385
Email cesare.hassan@hunimed.eu
Status Recruiting
Phase N/A
Start date September 21, 2023
Completion date September 1, 2027

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