Pillcam
Research type
Research Study
Full title
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.
IRAS ID
317522
Contact name
Richard Lee
Contact email
Sponsor organisation
The Royal Marsden Hospital NHS Foundation Trust
Duration of Study in the UK
1 years, 5 months, 28 days
Research 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 during and post the COVID pandemic. The colon capsule is an alternative investigation; however it is time consuming for the clinician and issuing a report takes several hours of reading by the clinician.
We propose to obtain images from paired colonoscopies and colon capsules with the purpose of developing an AI algorithm that could aid clinicians in reading the colon images and expand access to this investigation. This could potentially allow more patients to have a bowel examination in a timely manner, including those who present in primary care with lower GI symptoms such as bleeding or non-specific constitutional symptoms.
Our study is a feasibility study to determine whether it is feasible to obtain paired images from patients and to explore the development of algorithms using the data obtained.
At recruitment, patients who have a high risk of developing bowel cancer will undergo a colon capsule investigation, which is specifically designed to visualize the colon, followed immediately by a baseline colonoscopy as per their normal standard of care.
Participants will only undergo one single bowel preparation, which will suffice for both colonoscopy and colon capsule.During this clinical study, we will collect paired endoscopic images from colonoscopies and colon capsules and anonymized images will be transferred to the bioinformatics team for image analysis.
The recruitment and image analysis is estimated to be completed in 18 months. If this clinical study will be successful, further trials will be opened, allowing for a larger population to be included and to obtain more robust data, which eventually can lead to the application of colon capsules as a screening tool in at-risk populations.
REC name
London - Bromley Research Ethics Committee
REC reference
23/PR/0812
Date of REC Opinion
8 Dec 2023
REC opinion
Further Information Favourable Opinion