RecruitingNot ApplicableNCT06712095

Video Capsule Examination in Patients With Lynch Syndrome

Video Capsule Examination in Patients With Lynch and Other Cancer-predisposition Syndromes - a Proof-of-concept Study for Obtaining Data to Support the Development of Machine Learning Algorithms to Detect Early Cancers


Sponsor

Royal Marsden NHS Foundation Trust

Enrollment

25 participants

Start Date

Mar 4, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study uses a swallowable camera (video capsule endoscopy) to look at the small intestine in people with Lynch syndrome or other inherited cancer syndromes, to check for early signs of cancer or polyps. **You may be eligible if...** - You are over 18 years old - You do not currently have active cancer - You carry a known genetic mutation linked to hereditary cancer syndromes (such as Lynch syndrome: MLH1, MSH2, MSH6, PMS2; or FAP, Peutz-Jeghers, juvenile polyposis, or other related syndromes) - You have not had major surgery removing parts of your colon or rectum - You are able to consent and undergo colonoscopy **You may NOT be eligible if...** - You have had extensive bowel surgery that could cause the capsule to get stuck - You have had prior radiation to the abdomen or pelvis Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEVideo capsule investigation

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


Locations(1)

The Royal Marsden NHS Foundation Trust

London, (Select), United Kingdom

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NCT06712095


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