Using video capsules to examine patients with Lynch Syndrome

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to explore the feasibility of using video capsule examinations as an alternative to traditional colonoscopy for patients with Lynch Syndrome and other cancer predisposition syndromes. By obtaining paired images from both colonoscopies and video capsules, the researchers intend to develop an AI algorithm that can assist clinicians in interpreting the images more efficiently. The study will assess the willingness of patients to participate and the technical ability to gather usable data from these paired examinations. The ultimate goal is to enhance access to colorectal cancer surveillance for at-risk patients.

Why it matters

Who can join: the full rules

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

Where it's running

• The Royal Marsden NHS Foundation Trust
  London, (Select), United Kingdom Recruiting

Study contacts

• Principal investigator: Richard Lee, PhD — Royal Marsden NHS Foundation Trust
• Study coordinator: Elena Cojocaru, MD
• Email: elena.cojocaru@nhs.net
• Phone: +44 20 7808 2603

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.