NCT06799793 Artificial Intelligence-based Screening Models for Prevention and Early Detection of Colorectal Cancer
| NCT ID | NCT06799793 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna |
| Condition | Colorectal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,400 participants |
| Start Date | 2024-12-03 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,400 participants in total. It began in 2024-12-03 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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 Criteria: * 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).
Contact & Investigator
Giovanni Barbara, MD
PRINCIPAL INVESTIGATOR
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Frequently Asked Questions
Who can join the NCT06799793 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, up to 69 Years, studying Colorectal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06799793 currently recruiting?
Yes, NCT06799793 is actively recruiting participants. Contact the research team at giovanni.barbara@unibo.it for enrollment information.
Where is the NCT06799793 trial being conducted?
This trial is being conducted at Bologna, Italy.
Who is sponsoring the NCT06799793 clinical trial?
NCT06799793 is sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna. The principal investigator is Giovanni Barbara, MD at IRCCS Azienda Ospedaliero-Universitaria di Bologna. The trial plans to enroll 1,400 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.