Lynch SyndromePILLCAMNCT06712095
Video Capsule Examination in Patients With Lynch Syndrome
A study testing Video capsule investigation in people with Lynch Syndrome and Li Fraumeni Syndrome, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lynch Syndrome, Li Fraumeni Syndrome, PTEN Hamartoma Syndrome
- What is being tested?
- Video capsule investigation
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Mar 2024to 31 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Lydia Taylor, RN contact
United Kingdom1 site, 1 recruiting
- Recruiting
The Royal Marsden NHS Foundation Trust
London, (Select), SW3 6JJ
Elena Cojocaru, MD, +44 020 7352 8171 ext. 2603, elena.cojocaru@nhs.net
Lydia Taylor, RN, +44 020 7352 8171 ext. 2603, lydia.taylor@rmh.nhs.uk
About this study
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
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.
Read more
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
- Lynch Syndrome, Li Fraumeni Syndrome, PTEN Hamartoma Syndrome, FAP, MUTYH Biallelic Mutation, STK11 Mutation
- Being tested
- Video capsule investigation
- Medical subject headings
- Colorectal Neoplasms, Hereditary Nonpolyposis, Li-Fraumeni Syndrome, Hamartoma Syndrome, Multiple
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video capsule investigationDevice
Also called Colonoscopy
Participants will undergo both a video capsule examination and a colonoscopy on the same day.
| Study group | Role | What they receive |
|---|---|---|
| Videocapsule investigation | Experimental | Not described Receives: Device: Video capsule investigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of paired images the bioinformatician assesses as useful for the development of algorithm
Measured: 18 months
Secondary outcomes (3)
The proportion of patients at high-risk as defined by inclusion criteria who agree to undergo video capsule examination.
Measured: 18 months
The proportion of patients who undergo both video capsule examination and colonoscopy, from whom it is possible to obtain paired images
Measured: 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.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2024
- Study start4 Mar 2024
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lynch SyndromeStudies of the same condition, open and under way.
- More trials run by Royal Marsden NHS Foundation TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- King's College London
- Responsible party
- Sponsor
- Investigators
- Richard Lee, PhD, Principal investigator, Royal Marsden NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06712095
- Sponsor's protocol ID
- CCR5717
- Acronym
- PILLCAM
- Status last verified
- Dec 2024
- First submitted
- 26 Nov 2024
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06712095
- Acronym / sponsor ID
- PILLCAM / CCR5717
- Conditions
- Lynch Syndrome, Li Fraumeni Syndrome, PTEN Hamartoma Syndrome, FAP, MUTYH Biallelic Mutation, STK11 Mutation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Collaborators
- King's College London
- Study start
- 4 Mar 2024 (actual)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 2 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Videocapsule investigation | Experimental | Device: Video capsule investigation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Video capsule investigationAlso: ColonoscopyParticipants will undergo both a video capsule examination and a colonoscopy on the same day. | Device | Videocapsule investigation |
Primary outcome
The proportion of paired images the bioinformatician assesses as useful for the development of algorithm
Time frame: 18 months
3 secondary outcomes
The proportion of patients at high-risk as defined by inclusion criteria who agree to undergo video capsule examination.
Time frame: 18 months
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
The description of any adverse events collected for the Pillcam procedure.
Time frame: 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
Related trials for Lynch Syndrome
RecruitingPhase 2
A Phase IIa Randomized, Double-Blinded Clinical Trial of Naproxen or Aspirin for Cancer Immune Interception in Lynch Syndrome
T Cells, Colorectal Cancer
Recruiting
FITting Non-invasive Tests in Lynch Syndrome Surveillance
Colorectal Cancer
Active, not recruitingObservational study
The IMPACT Study - Identification of Men With a Genetic Predisposition to ProstAte Cancer
Prostate Cancer, BRCA Mutation
RecruitingObservational study
Analysing Outcomes After Prostate Cancer Diagnosis and Treatment in Carriers of Rare Germline Mutations
Prostate Cancer
Active, not recruitingPhase 3
Combination Chemotherapy With or Without Atezolizumab in Treating Patients With Stage III Colon Cancer and Deficient DNA Mismatch Repair
Colon Adenocarcinoma, DNA Repair Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lydia Taylor, RN contact
Richard Lee, PhD principal investigator
Royal Marsden NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video capsule investigation in people with Lynch Syndrome and Li Fraumeni Syndrome, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elena Cojocaru, MD (+44 20 7808 2603, elena.cojocaru@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of paired images the bioinformatician assesses as useful for the development of algorithm (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2024.