AI-based screening for colorectal cancer prevention and early detection

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.