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
IRCCS Azienda Ospedaliero-Universitaria di Bologna
1,400 participants
Dec 3, 2024
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
Inclusion Criteria4
- Subjects aged 50-69 years who underwent the fecal occult blood screening program
- Male and female sex
- Positivity to fecal occult blood (FIT) on the immunochemical screening test (OC-Sensor);the cut-off for determination of test positivity is 20 micrograms HgB/gr of stool (cut-off used in our country).
- Subjects who provided written consent to participate in the study.
Exclusion Criteria8
- Subjects who do not understand the Italian language
- Subjects with previous history of total colectomy or bowel resections
- Subjects with colonoscopy performed in the previous 12 months
- Subjects with contraindications to colonoscopy
- Subjects who have contraindication to sedation or anesthesia
- Subjects with a personal history of CRC
- Subjects with hereditary gastrointestinal cancer syndrome: familial adenomatous polyposis (FAP), attenuated FAP, MutYH-associated polyposis, Lynch or Lynch-like syndrome, and serratus polyposis syndrome.
- Subjects with inflammatory bowel disease (Crohn's disease, ulcerative colitis).
Interventions
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).
Colonoscopy with one of the Olympus colonoscopes supplied to the IRCCS AOUBO Gastroenterology Unit without the aid of the CAD system
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06799793