CompletedNot Applicable

The Yield of Artificial Intelligence (GI Genius) in Lynch Syndrome - A Randomized Tandem-colonoscopy Trial

Israel100 participantsStarted 2024-11-03

Plain-language summary

We aim to investigate the incremental detection rate of polyps using AI- assisted colonoscopy compared with high-definition white-light endoscopy (HD-WLE). We will conduct a single-center randomized tandem colonoscopy trial of patients with Lynch syndrome with and without AI. Patients will undergo tandem colonoscopy, the second colonoscopy with either HD-WLE or an AI- assisted device.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * patients with a known pathogenic variant in one of the mismatch repair genes, who are undergoing endoscopic screening and surveillance in our institute Exclusion Criteria: * patients \< 18 years old * lack of informed consent * concomitant inflammatory bowel disease * previous total colectomy * inadequate bowel cleansing (Boston Bowel Preparation Scale (BBPS) ≤5 or \< 2 in one of the 3 segments)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

adenoma incremental detection rate

Timeframe: From the start of the first colonoscopy until the end of the second colonoscopy, performed on the day of enrollment (both colonoscopies performed consecutively on the same day).]

Trial details

NCT IDNCT06654128

SponsorSheba Medical Center

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2025-11-01

View on ClinicalTrials.gov More Lynch Syndrome trials