RecruitingNAINTERVENTIONAL

Video Capsule Examination in Patients With Lynch Syndrome

This study aims to find a quicker way to check for bowel cancer in people who have a higher chance of developing it due to inherited conditions like Lynch Syndrome. Currently, a common test is a colonoscopy, but these can be hard to access quickly. Another option is a colon capsule, which is a tiny camera you swallow, but reading all the images takes a long time for doctors. Researchers want to see if they can collect good quality images from both colonoscopies and colon capsules in the same people. They plan to use these images to train a special computer program (AI) to help doctors review the capsule images more quickly and accurately. If successful, this could make vital screening available to more people at risk.

At a glance

Status

Recruiting

Phase

Sponsor

Royal Marsden NHS Foundation Trust

Enrolment target

Start

04 Mar 2024

Estimated completion

31 Oct 2025

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

What is this study about?

This study is looking into a new way to check for bowel cancer in people who have certain inherited conditions, like Lynch Syndrome, that increase their risk. Currently, the main way to check is with a colonoscopy, where a doctor uses a tube with a camera to look inside your bowel. However, getting an appointment for a colonoscopy can sometimes take a while.

There's another method called a colon capsule. This is a tiny camera inside a capsule that you swallow. It travels through your digestive system, taking pictures along the way, and you simply pass it out. While this sounds convenient, doctors need to spend a lot of time (sometimes up to an hour) reviewing all the images it takes. This makes it difficult to use widely.

This research aims to solve that problem. The main goal is to collect detailed images from both a colonoscopy and a colon capsule from the same people. These images will then be used to create and teach an advanced computer program, known as AI (Artificial Intelligence). This AI would help doctors interpret the capsule images much faster. If this study works out, it could mean that many more people at risk of bowel cancer could get checked more easily and quickly in the future, making screening more accessible.

Key takeaways

Aims to make bowel cancer screening easier and faster.
Uses a tiny camera you swallow (colon capsule) and a standard colonoscopy.
Researchers want to teach a computer program (AI) to read capsule images quickly.
Could help more people at risk get checked for bowel cancer.
You participate by having both a colon capsule and your usual colonoscopy.
You can stop participating at any time.

Who may be eligible?

You might be able to join this study if you are over 18 years old and do not have active cancer. You should not have had surgery to remove part of your bowel or rectum.

The study is specifically looking for people who have been diagnosed with certain inherited conditions or gene changes that increase their risk of cancer. These include conditions like Lynch syndrome, FAP syndrome, and others related to specific gene variants (like MLH1, APC, MUTYH, STK11, PTEN, CDH1, CHEK2, TP53, BMPR1A, and SMAD4).

However, you cannot join if you've had extensive bowel surgery that might cause blockages, or if you've had radiation treatment to your tummy or pelvis. Also, you can't participate if you have a pacemaker or some other internal electronic medical devices, or if you are pregnant or have insulin-dependent diabetes. If you need deep sedation (stronger sleepy medicine) for a colonoscopy, you also wouldn't be able to take part.

Quick self-check

Are you over 18 years old?
Do you have an inherited condition that increases your cancer risk (e.g., Lynch syndrome)?
Have you NOT had major bowel or rectum surgery?
Do you NOT have a pacemaker or other internal electronic device?
Are you NOT pregnant and do you NOT have insulin-dependent diabetes?
Can you have a colonoscopy without needing very strong sedation?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you would first have a colon capsule investigation. This involves swallowing a small capsule with a camera inside, which then takes pictures as it passes through your bowel. Shortly after this, you would have a routine colonoscopy, just as you would normally, as part of your regular medical checks. Both your colon capsule and colonoscopy images will be collected. Your personal details will be removed so that the images are anonymous, and a specialist will use these images for analysis. The study doesn't involve any new medications or extra follow-up appointments beyond your usual care. The total duration of your active participation would be the time taken for these two procedures.

Potential risks and benefits

Taking part in this study might benefit future patients by helping to develop a faster and more accessible way to screen for bowel cancer. For you, there are no direct personal benefits beyond your usual care, as you'll be having your standard colonoscopy anyway. Risks associated with the colon capsule are generally low, but there's a small chance of the capsule getting stuck, though this is less likely in people without bowel narrowing. Colonoscopies also carry small risks, which your doctor will discuss with you. You are free to withdraw from the study at any time without giving a reason, and this will not affect your medical care.

Locations (1)

The Royal Marsden NHS Foundation Trust
London, United Kingdom· Recruiting

Common questions

What is a colon capsule?

It's a small camera inside a capsule that you swallow. It takes pictures of your bowel as it moves through your body.

What is AI?

AI stands for Artificial Intelligence. It's a special computer program that can learn from images to help doctors quickly look at and understand the pictures from the colon capsule.

Will I get my results from the capsule and colonoscopy?

Yes, you will receive results from your colonoscopy and colon capsule as part of your routine medical care.

Will this study change my regular care?

No, you will still receive your usual medical checks, including routine colonoscopies, as advised by your doctor.

Can the capsule get stuck?

There's a very small chance the capsule could get stuck, especially if you have parts of your bowel that are very narrow. Doctors will assess this risk before you take part.

How to find out more

Elena Cojocaru, MD

elena.cojocaru@nhs.net +44 20 7808 2603 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.