Video Capsule Examination in Patients With Lynch Syndrome (PILLCAM)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Lynch Syndrome; FAP; CDH1 Gene Mutation; CHEK2 Gene Mutation; BMPR1A Gene Mutation; PTEN Hamartoma Syndrome; Li Fraumeni Syndrome; SMAD4 Gene Mutation; MUTYH Biallelic Mutation; STK11 Mutation
• Intervention / Treatment: Device: Video capsule investigation

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elena Cojocaru, MD; Phone Number: +44 20 7808 2603; Email: elena.cojocaru@nhs.net
• Study Contact Backup: Name: Lydia Taylor, RN; Email: lydia.taylor@rmh.nhs.uk

Study Locations

• United Kingdom
  • (Select)
    • London, (Select), United Kingdom, SW3 6JJ
      • Recruiting
      • The Royal Marsden NHS Foundation Trust
      • Contact: Elena Cojocaru, MD; Phone Number: 2603 +44 020 7352 8171; Email: elena.cojocaru@nhs.net
      • Contact: Lydia Taylor, RN; Phone Number: 2603 +44 020 7352 8171; Email: lydia.taylor@rmh.nhs.uk
      • Principal Investigator: Richard Lee, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Videocapsule investigation	Device: Video capsule investigation; Participants will undergo both a video capsule examination and a colonoscopy on the same day.; Other Names: Colonoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The proportion of paired images the bioinformatician assesses as useful for the development of algorithm	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The proportion of patients at high-risk as defined by inclusion criteria who agree to undergo video capsule examination.		18 months
The proportion of patients who undergo both video capsule examination and colonoscopy, from whom it is possible to obtain paired images		18 months
The description of any adverse events collected for the Pillcam procedure.	All adverse events will be collected using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.	18 months

Collaborators and Investigators

• Sponsor: Royal Marsden NHS Foundation Trust
• Collaborators: King's College London
• Investigators: Principal Investigator: Richard Lee, PhD, Royal Marsden NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2024
• Primary Completion (Estimated): October 31, 2025
• Study Completion (Estimated): October 31, 2025

Study Registration Dates

• First Submitted: November 26, 2024
• First Submitted That Met QC Criteria: November 29, 2024
• First Posted (Actual): December 2, 2024

Study Record Updates

• Last Update Posted (Estimated): December 5, 2024
• Last Update Submitted That Met QC Criteria: December 3, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Site; Neoplasms; Genetic Diseases, Inborn; Metabolic Diseases; Intestinal Diseases; Disease; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Colonic Diseases; Neoplastic Syndromes, Hereditary; Neoplasms, Multiple Primary; DNA Repair-Deficiency Disorders; Syndrome; Colorectal Neoplasms, Hereditary Nonpolyposis; Li-Fraumeni Syndrome; Hamartoma; Hamartoma Syndrome, Multiple
• Other Study ID Numbers: CCR5717

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No