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Video Capsule Examination in Patients With Lynch Syndrome

RecruitingNAAges 18 Years - anyAllRoyal Marsden NHS Foundation Trust
NCT06712095 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 te

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📋 Eligibility rules (as published)
Inclusion Criteria: * Patients over the age of 18 years old with no active cancer * No previous resection of the colon and/or rectum * Carriers of a pathogenic/likely pathogenic variant in any of the following cancer-predisposition genes: Lynch syndrome (MLH1, MSH2, MSH6, PMS2), APC (FAP syndrome); biallelic MUTYH; STK11 (Peutz-Jeghers syndrome); PTEN, CDH1, CHEK2, TP53, BMPR1A and SMAD4 (Juvenile polyposis syndrome) * Able to consent to the study and undergo colonoscopy. Exclusion Criteria: * Extensive surgery which poses a high risk of video-capsule blockage or narrowing of the bowel due to extensive tumour. Extensive surgery implies any removal of large portions of the small or large bowel that might cause a narrowing (stricture) in the digestive tract. * Previous irradiation to abdomen or pelvis (risk for small bowel obstruction) * Carriers of a variant associated with reduced penetrance (in the view of a geneticist) or a variant of uncertain significance. * Patients with a PS of 3 or 4 and/or mobility issues * Pregnancy * Pacemaker or internal electro-medical device (artificial heart valve, cochlear implant or an internal electromedical device). * Insulin-dependent diabetes * Patients who require deep sedation for colonoscopy
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What it tests

  • Video capsule investigation
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Where

1 site
The Royal Marsden NHS Foundation Trust
London, United Kingdom
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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