Video Capsule Examination in Patients With Lynch Syndrome

NCT ID: NCT06712095

Last Updated: 2024-12-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-04
• Study Completion Date: 2025-10-31

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Videocapsule investigation

Group Type: EXPERIMENTAL

Video capsule investigation

Intervention Type: DEVICE

Participants will undergo both a video capsule examination and a colonoscopy on the same day.

Interventions

Video capsule investigation

Participants will undergo both a video capsule examination and a colonoscopy on the same day.

Intervention Type: DEVICE

Other Intervention Names

Colonoscopy

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

King's College London

OTHER

Sponsor Role: collaborator

Royal Marsden NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard Lee, PhD

Role: PRINCIPAL_INVESTIGATOR

Royal Marsden NHS Foundation Trust

Locations

The Royal Marsden NHS Foundation Trust

London, (Select), United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Elena Cojocaru, MD

Role: CONTACT

Phone: +44 20 7808 2603

Email: elena.cojocaru@nhs.net

Lydia Taylor, RN

Role: CONTACT

Email: lydia.taylor@rmh.nhs.uk

Facility Contacts

Elena Cojocaru, MD

Role: primary

Lydia Taylor, RN

Role: backup

Other Identifiers

CCR5717

Identifier Type: -

Identifier Source: org_study_id