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RECRUITING
NCT06799793
NA

Artificial Intelligence-based Screening Models for Prevention and Early Detection of Colorectal Cancer

Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

View on ClinicalTrials.gov

Summary

Colorectal cancer screening is based on the fecal occult blood test (FIT), which has low sensitivity for adenomatous polyps, based on the currently used cut-off. Risk factors such as obesity, diabetes, alcohol, and cigarette smoking are associated with the presence of high-risk neoplasia in the screening population. CADe systems appear to increase ADR in screening programs; however, uncertainty remains regarding their true effectiveness. The study could provide the tools to: 1. devise a personalized pathway of CRC screening so as to refer to colonoscopy (with CAD or without CAD depending on the results that will be obtained) those at high risk of carrying neoplasms amenable to removal or curative treatment; 2. define risk categories for theoretical screening models giving the possibility of moving from the concept "one size fits all" to that of "personalized and precision prevention".

Official title: Definire Modelli di Screening Personalizzati, Basati Sull'Intelligenza Artificiale, Per la Prevenzione e la Diagnosi Precoce Del Cancro Del Colon-retto

Key Details

Gender

All

Age Range

50 Years - 69 Years

Study Type

INTERVENTIONAL

Enrollment

1400

Start Date

2024-12-03

Completion Date

2026-12-31

Last Updated

2025-01-29

Healthy Volunteers

No

Interventions

DEVICE

GI Genius

GI Genius software component is an artificial intelligence-based medical device that has been trained to process colonoscopy images containing regions consistent with colorectal lesions such as polyps, including those with flat morphology (nonpolyp).

OTHER

Colonscope Olympus

Colonoscopy with one of the Olympus colonoscopes supplied to the IRCCS AOUBO Gastroenterology Unit without the aid of the CAD system

Locations (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Bologna, Italy