Using video capsules to examine patients with Lynch Syndrome

Video Capsule Examination in Patients With Lynch and Other Cancer-predisposition Syndromes - a Proof-of-concept Study for Obtaining Data to Support the Development of Machine Learning Algorithms to Detect Early Cancers

This study is testing whether video capsules can be a good alternative to regular colonoscopies for people with Lynch Syndrome to help improve cancer screening.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 25 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Royal Marsden NHS Foundation Trust (Academic / other)
• Locations: 1 site (London, (Select))
• Trial ID: NCT06712095 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults over 18 years old who are carriers of specific pathogenic variants associated with cancer predisposition and have not undergone previous colon or rectal surgery.

Not a fit: Patients with extensive bowel surgery or those with active cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve colorectal cancer surveillance for patients with Lynch Syndrome and related conditions.

How similar studies have performed: While the use of video capsules is gaining traction, this specific approach of pairing it with AI analysis for Lynch Syndrome patients is relatively novel and has not been extensively tested in prior studies.

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

Where this trial is running

London, (Select)

• 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

Conditions Lynch Syndrome; Li Fraumeni Syndrome; PTEN Hamartoma Syndrome; FAP; MUTYH Biallelic Mutation; STK11 Mutation; CDH1 Gene Mutation; CHEK2 Gene Mutation