Clinical trial NCT06712095: Video Capsule Examination in Patients With Lynch Syndrome
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lynch Syndrome
Li Fraumeni Syndrome
PTEN Hamartoma Syndrome
FAP
MUTYH Biallelic Mutation
STK11 Mutation
CDH1 Gene Mutation
CHEK2 Gene Mutation
BMPR1A Gene Mutation
SMAD4 Gene Mutation
Lead sponsor: Royal Marsden NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: King's College London
First posted: 2024-12-02
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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 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.


Eligibility criteria: 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

Primary outcomes:
measure: The proportion of paired images the bioinformatician assesses as useful for the development of algorithm
timeFrame: 18 months
Secondary outcomes:
measure: The proportion of patients at high-risk as defined by inclusion criteria who agree to undergo video capsule examination.
timeFrame: 18 months
measure: The proportion of patients who undergo both video capsule examination and colonoscopy, from whom it is possible to obtain paired images
timeFrame: 18 months
measure: The description of any adverse events collected for the Pillcam procedure.
timeFrame: 18 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: The Royal Marsden NHS Foundation Trust
state: (Select)
Study officials:
affiliation: Royal Marsden NHS Foundation Trust
name: Richard Lee, PhD
role: PRINCIPAL_INVESTIGATOR
References: