Video Capsule Examination in Patients With Lynch Syndrome

Summary

Surveillance for colorectal cancer (CRC) in patients predisposed to develop CRC during their lifetime has been impacted by access to colonoscopy suites and endoscopy specialists in the past couple of years. An alternative method, namely the colon capsule, has been proposed, however this investigation is time consuming for the clinician and the images require up to one hour (30-60 minutes) reading to issue a result. The investigators propose to obtain images from paired colonoscopies and colon capsules with the purpose of developing an AI algorithm which could aid the clinicians in reading the colon and expand access to this investigation.

The main aim of the study is to determine whether it is possible to obtain usable paired images from patients with Lynch and other cancer predisposition syndromes. This will depend on the willingness of the patients to take part in the study and the technical ability of obtaining data from paired images of colonoscopies and colon capsule.

At recruitment, participants will undergo a colon capsule investigation, followed by a routine colonoscopy as per their normal standard of care. Paired endoscopic images from colonoscopies and colon capsules will be collected and anonymised data will be accessed by the bioinformatician for analysis.

If the study will be successful in reaching the primary endpoint, further trials will be opened, allowing for a larger population to be included and to obtain more robust data, which eventually can lead to validated AI algorithms and application of computer-aided video-capsules examination as a screening tool in at-risk population.

Conditions

• Lynch Syndrome
• Li Fraumeni Syndrome
• PTEN Hamartoma Syndrome
• FAP
• MUTYH Biallelic Mutation
• STK11 Mutation
• CDH1 Gene Mutation
• CHEK2 Gene Mutation
• BMPR1A Gene Mutation
• SMAD4 Gene Mutation

Interventions

DEVICE

Video capsule investigation

Participants will undergo both a video capsule examination and a colonoscopy on the same day.

Sponsors & Collaborators

• King's College London

  collaborator OTHER

• Royal Marsden NHS Foundation Trust

  lead OTHER

Principal Investigators

• Richard Lee, PhD · Royal Marsden NHS Foundation Trust

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-03-04

Primary Completion

2025-10-31

Completion

2025-10-31

Countries

• United Kingdom

Study Locations