NCT06799793Recruiting
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
Source: ClinicalTrials.gov · Last updated 29 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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".
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 1400 (estimated)
- First submitted
- 28 Nov 2024
- Start date
- 3 Dec 2024
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Diseases
- Colorectal cancer
- NCT number
- NCT06799793
What you commit to
- Study type: Interventional
- Planned participants: 1400
- From 3 Dec 2024 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Subjects with previous history of total colectomy or bowel resections
- Subjects with colonoscopy performed in the previous 12 months
Other illness
- 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).
Other
- Subjects who do not understand the Italian language
- Subjects with contraindications to colonoscopy
- Subjects who have contraindication to sedation or anesthesia
Who the study is looking for
- 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.
Age in the registry: 50 years to 69 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| IRCCS Azienda Ospedaliero-Universitaria di Bologna Coordinator of this site? Confirm its status | Bologna | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.