Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
NCT06712095

Video Capsule Examination in Patients With Lynch Syndrome

Led by Royal Marsden NHS Foundation Trust · Updated on 2024-12-05

25

Participants Needed

1

Research Sites

86 weeks

Total Duration

On this page

Sponsors

R

Royal Marsden NHS Foundation Trust

Lead Sponsor

K

King's College London

Collaborating Sponsor

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

Video Capsule Examination in Patients With Lynch Syndrome

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 or likely pathogenic variant in cancer-predisposition genes including Lynch syndrome (MLH1, MSH2, MSH6, PMS2), APC (FAP), biallelic MUTYH, STK11 (Peutz-Jeghers), PTEN, CDH1, CHEK2, TP53, BMPR1A, and SMAD4 (Juvenile polyposis syndrome)
  • Able to consent to the study and undergo colonoscopy
Not Eligible

You will not qualify if you...

  • Extensive surgery causing high risk of video-capsule blockage or narrowing of the bowel
  • Previous radiation to the abdomen or pelvis increasing risk of small bowel obstruction
  • Carriers of variants with reduced penetrance or uncertain significance as determined by a geneticist
  • Patients with performance status 3 or 4 and/or mobility issues
  • Pregnancy
  • Having a pacemaker or internal electro-medical device such as artificial heart valve or cochlear implant
  • Insulin-dependent diabetes
  • Patients requiring deep sedation for colonoscopy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

The Royal Marsden NHS Foundation Trust

London, (Select), United Kingdom, SW3 6JJ

Actively Recruiting

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Research Team

E

Elena Cojocaru, MD

CONTACT

L

Lydia Taylor, RN

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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