Video Capsule Examination in Patients With Lynch Syndrome
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
| Condition(s) | 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 |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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 |
| Who can participate | 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 |
| Ages | 18 Years |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | Royal Marsden NHS Foundation Trust |
| Locations | London, (Select), United Kingdom |
| Start date | 2024-03-04 |
| NCT ID | NCT06712095 |
| Official listing | https://clinicaltrials.gov/study/NCT06712095 |