Video Capsule Examination in Patients With Lynch Syndrome

Launched by ROYAL MARSDEN NHS FOUNDATION TRUST · Nov 29, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring a new way to help doctors check for colon cancer in patients who have a higher risk due to conditions like Lynch Syndrome and other related genetic syndromes. Traditionally, doctors use a procedure called colonoscopy, but getting access to this can sometimes be difficult. As an alternative, a small camera inside a capsule (called a colon capsule) is being tested to see if it can provide helpful images of the colon. The goal of this study is to collect images from both the colon capsule and colonoscopy to help develop a computer program that can make reading these images easier and faster for doctors.

To participate in this study, you need to be at least 18 years old, not currently have cancer, and have a specific genetic mutation related to cancer risk. You will first swallow the capsule, and then undergo a routine colonoscopy as part of your regular care. This study is currently recruiting participants, and if successful, could lead to larger studies that might improve screening methods for people at risk of colon cancer in the future. It's important to note that certain health conditions may make you ineligible, like having a pacemaker or needing deep sedation for the colonoscopy.

Gender

ALL

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