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NCT Number: NCT06712095

Video Capsule Examination in Patients With Lynch Syndrome

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.

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Key information

Conditions

Lynch Syndrome BMPR1A Gene Mutation CDH1 Gene Mutation CHEK2 Gene Mutation Colonic Diseases Colorectal Neoplasms Colorectal Neoplasms, Hereditary Nonpolyposis Congenital, Hereditary, and Neonatal Diseases and Abnormalities DNA Repair-Deficiency Disorders Digestive System Diseases Digestive System Neoplasms FAP Gastrointestinal Diseases Gastrointestinal Neoplasms Genetic Diseases, Inborn Hamartoma Hamartoma Syndrome, Multiple Intestinal Diseases Intestinal Neoplasms Li Fraumeni Syndrome Li-Fraumeni Syndrome MUTYH Biallelic Mutation Metabolic Diseases Neoplasms Neoplasms by Site Neoplasms, Multiple Primary Neoplastic Syndromes, Hereditary Nutritional and Metabolic Diseases PTEN Hamartoma Syndrome SMAD4 Gene Mutation STK11 Mutation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Royal Marsden NHS Foundation Trust

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

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Video capsule investigation

Device

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

Other names: Colonoscopy

Primary outcomes

  1. The proportion of paired images the bioinformatician assesses as useful for the development of algorithm

    Time frame: 18 months

Secondary outcomes

  1. The proportion of patients at high-risk as defined by inclusion criteria who agree to undergo video capsule examination.

    Time frame: 18 months

  2. The proportion of patients who undergo both video capsule examination and colonoscopy, from whom it is possible to obtain paired images

    Time frame: 18 months

  3. The description of any adverse events collected for the Pillcam procedure.

    Time frame: 18 months

    All adverse events will be collected using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Royal Marsden NHS Foundation Trust

Other

Collaborators

  • King's College London

Registry information

Official study 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

Acronym: PILLCAM

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 2, 2024
Registry last updated
Dec 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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