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Artificial Intelligence to Implement Cost-saving Strategies for Colonoscopy Screening Based on in Vivo Prediction of Polyp Histology
Sponsor: Istituto Clinico Humanitas
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.
Official title: 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
Key Details
Gender
All
Age Range
40 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1800
Start Date
2023-09-21
Completion Date
2027-09-01
Last Updated
2023-10-04
Healthy Volunteers
Yes
Conditions
Interventions
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.
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.
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