RecruitingNot ApplicableNCT06799793

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

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


Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Enrollment

1,400 participants

Start Date

Dec 3, 2024

Study Type

INTERVENTIONAL

Conditions

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".


Eligibility

Min Age: 50 YearsMax Age: 69 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether AI-based computer models can improve the way doctors interpret positive bowel cancer screening results to better identify which patients are most likely to have colorectal cancer (bowel cancer) or advanced pre-cancerous polyps, and should be prioritized for colonoscopy. **You may be eligible if...** - You are between 50 and 69 years old - You tested positive for blood in your stool on a standard immunochemical fecal occult blood test (FIT test) as part of a national screening program - You provided written consent **You may NOT be eligible if...** - You do not understand Italian - You have had your entire colon or part of your bowel surgically removed - You had a colonoscopy within the last 12 months - You have a personal history of colorectal cancer - You have hereditary colorectal cancer syndromes (like Lynch syndrome or FAP) - You have a reason you cannot safely have a colonoscopy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEGI 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).

OTHERColonscope 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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06799793


Related Trials