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

NCT06799793 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1400

Last updated 2025-01-29

No results posted yet for this study

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".

Conditions

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

Sponsors & Collaborators

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna

    lead OTHER

Principal Investigators

  • Giovanni Barbara, MD · IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-03
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06799793 on ClinicalTrials.gov