AI-based screening for colorectal cancer prevention and early detection
Definire Modelli di Screening Personalizzati, Basati Sull'Intelligenza Artificiale, Per la Prevenzione e la Diagnosi Precoce Del Cancro Del Colon-retto
This study is testing if using artificial intelligence can create personalized screening plans for people aged 50-69 who have positive fecal blood tests to better identify those at high risk for colorectal cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1400 (estimated) |
| Ages | 50 Years to 69 Years |
| Sex | All |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Locations | 1 site (Bologna, Bologna) |
| Trial ID | NCT06799793 on ClinicalTrials.gov |
What this trial studies
This study aims to enhance colorectal cancer screening by utilizing artificial intelligence to develop personalized screening pathways. It focuses on individuals aged 50-69 who have tested positive for fecal occult blood, assessing their risk factors to determine the need for colonoscopy. The goal is to move away from a one-size-fits-all approach to a more tailored strategy that identifies those at high risk for neoplasms. The study will employ advanced AI tools like GI Genius and Colonscope Olympus to improve detection rates.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 50-69 who have tested positive for fecal occult blood in a screening program.
Not a fit: Patients with a personal history of colorectal cancer or hereditary gastrointestinal cancer syndromes will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to earlier detection and prevention of colorectal cancer, significantly improving patient outcomes.
How similar studies have performed: Other studies have shown promise in using AI for cancer detection, suggesting potential success for this novel approach.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Bologna, Bologna
- IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna, Bologna, Italy (Recruiting)
Study contacts
- Principal investigator: Giovanni Barbara, MD — IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Study coordinator: Giovanni Barbara, MD
- Email: giovanni.barbara@unibo.it
- Phone: +39 051 2142211
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.