NCT06041945

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,800 (estimated)
• Sponsor: Istituto Clinico Humanitas · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Accepted

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.

Conditions

• Colonic Neoplasms

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-09-21
• Primary completion: 2027-09-01
• Completion: 2027-09-01
• First posted: 2023-09-18
• Last updated: 2023-10-04

Locations

2 sites across 1 country: Italy