NCT06712095 Video Capsule Examination in Patients With Lynch Syndrome
| NCT ID | NCT06712095 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Royal Marsden NHS Foundation Trust |
| Condition | Lynch Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 25 participants |
| Start Date | 2024-03-04 |
| Primary Completion | 2025-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 25 participants in total. It began in 2024-03-04 with a primary completion date of 2025-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Richard Lee, PhD
PRINCIPAL INVESTIGATOR
Royal Marsden NHS Foundation Trust
Frequently Asked Questions
Who can join the NCT06712095 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Lynch Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06712095 currently recruiting?
Yes, NCT06712095 is actively recruiting participants. Contact the research team at elena.cojocaru@nhs.net for enrollment information.
Where is the NCT06712095 trial being conducted?
This trial is being conducted at London, United Kingdom.
Who is sponsoring the NCT06712095 clinical trial?
NCT06712095 is sponsored by Royal Marsden NHS Foundation Trust. The principal investigator is Richard Lee, PhD at Royal Marsden NHS Foundation Trust. The trial plans to enroll 25 participants.