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

NCT ID: NCT06654128

Last Updated: 2025-03-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-03

Study Completion Date

2025-07-01

Brief Summary

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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.

Detailed Description

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We will include patients with a known pathogenic variant (PV) / likely PV in one of the MMR genes, who are undergoing endoscopic screening and surveillance in our institute. Patients will undergo a first colonoscopy with HD-WLE, and will be randomized at 1:1 ratio to undergo a second colonoscopy with either HD-WLE or an AI- assisted device. All visualized polyps will be removed and size, histology and numbers of polyps detected on each exam will be recorded. We will evaluate the adenoma detection rate and polyp detection rate in each arm and the number of adenomas / polyps in each arm.

Conditions

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Lynch Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

comparison of 2 groups of patients undergoing tandem colonoscopy
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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high-definition white-light endoscopy

patients undergoing first and second colonoscopy with high-definition white-light endoscopy

Group Type NO_INTERVENTION

No interventions assigned to this group

artificial intelligence

patients undergoing first colonoscopy with high-definition white-light endoscopy and second colonoscopy with artificial intelligence

Group Type ACTIVE_COMPARATOR

artificial intelligence

Intervention Type DIAGNOSTIC_TEST

patients will undergo tandem colonoscopy with artificial intelligence

Interventions

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artificial intelligence

patients will undergo tandem colonoscopy with artificial intelligence

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sheba Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Sheba Medical Center

Ramat Gan, , Israel

Site Status

Countries

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Israel

Other Identifiers

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SHEBA-20-6956-IL-CTIL

Identifier Type: -

Identifier Source: org_study_id

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