Video Capsule Examination in Patients With Lynch Syndrome (PILLCAM)

Royal Marsden NHS Foundation Trust

Status

Enrolling

Conditions

PTEN Hamartoma Syndrome

CDH1 Gene Mutation

FAP

STK11 Mutation

SMAD4 Gene Mutation

Lynch Syndrome

BMPR1A Gene Mutation

MUTYH Biallelic Mutation

CHEK2 Gene Mutation

Li Fraumeni Syndrome

Treatments

Device: Video capsule investigation

Study type

Interventional

Funder types

Other

Identifiers

NCT06712095

CCR5717

Details and patient eligibility

About

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.

Enrollment

25 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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