Not yet recruitingNAINTERVENTIONAL

Study Aiming to Test Whether Non-invasive Liquid Biopsies Can Safely Reduce Invasive Surveillance Methods in Lynch Syndrome

Lynch syndrome increases your risk of certain cancers, like bowel or womb cancer. Currently, checking for these cancers often involves colonoscopies or other invasive procedures. While these work, they can be uncomfortable and might stop some people from getting regular checks. This study is exploring a new approach using 'liquid biopsies' – simple tests on samples like blood, urine, or stool. The main goal is to see if these easier tests can help doctors personalise your cancer checks, potentially allowing more time between those less comfortable procedures, while still making sure you get safe and effective monitoring. It's about finding ways to make cancer surveillance better and easier to manage.

At a glance

Status

Not yet recruiting

Phase

Sponsor

UNICANCER

Enrolment target

2,000

Start

01 Apr 2026

Estimated completion

01 Dec 2030

Lynch Syndrome

What is this study about?

Lynch syndrome is a condition passed down through families that makes you more likely to get certain cancers, especially bowel cancer and cancer of the womb. It affects quite a lot of people in the UK.

Right now, doctors mainly keep an eye on things by using procedures like colonoscopies, where a tiny camera looks inside your bowel. They might also take small tissue samples (biopsies) for testing. While these methods are good at finding cancer, they can be a bit uncomfortable and sometimes put people off having their regular checks. This means some might miss out on important monitoring they need.

This study, called PREDI-LYNCH, is looking into a different, potentially gentler way to check for cancer. It uses what are called 'liquid biopsies' – simple tests done on samples like blood, urine, or even stool. For women, it can also involve a vaginal swab. The hope is that these easier tests could help doctors create a more personal checking plan for you, possibly meaning you won't need as many of the more invasive procedures, while still keeping you safe and detecting any cancers early.

Key takeaways

Exploring gentler ways to check for cancer in Lynch syndrome.
Compares standard care with new 'liquid biopsy' tests.
Aims to reduce invasive procedures like colonoscopies.
Focuses on samples like blood, urine, and stool.
Could lead to more personalised cancer checking plans.
You must have confirmed Lynch syndrome to take part.

Who may be eligible?

To join this study, you need to be an adult between 35 and 80 years old and have a confirmed diagnosis of Lynch syndrome. This means tests have shown you have a specific change in certain genes (MLH1, MSH2, MSH6, or EPCAM).

There are also some reasons you might not be able to take part. For example, if you’ve already had your entire colon and rectum removed, or if you’ve been treated for cancer in the last two years. You also can’t join if you are pregnant or if doctors think you wouldn't be able to keep up with the study's appointments and requirements.

Quick self-check

Are you between 35 and 80 years old?
Do you have a genetically confirmed diagnosis of Lynch syndrome?
Have you NOT had your entire colon and rectum removed?
Have you NOT been treated for cancer in the last 2 years?
Are you able and willing to attend all study appointments?
Are you NOT currently pregnant?

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

What does participation involve?

If you join this study, you will either continue with the standard follow-up, which includes a colonoscopy every 18 months, or you will have a yearly 'liquid biopsy' (providing blood, urine, stool, and potentially vaginal samples) along with a colonoscopy every 36 months. If any of your liquid biopsy tests show something unusual, you will have extra checks straight away to confirm the results.

The study will also look at your quality of life and how healthcare is used. You'll have regular appointments to provide samples and sometimes undergo a colonoscopy. The exact duration of your participation will depend on which group you are in and will be explained fully by the study team.

Potential risks and benefits

Taking part in this study could potentially mean fewer invasive procedures like colonoscopies in the future, which might improve your comfort and quality of life. However, it's also possible that the liquid biopsies might not be as effective as current methods, or might lead to needing more frequent confirmatory tests. As with any medical study, there are always potential, though usually small, risks associated with the procedures involved, like colonoscopies or blood draws. You are free to withdraw from the study at any time without affecting your usual medical care.

Locations (9)

Klinicki Bolnicki Centar Sestre Milosrdnice Ustanova
Zagreb, Croatia
Masaryk Memorial Cancer Institute
Brno, Czechia
Tampereen Korkeakoulusäätiö SR
Helsinki, Finland
GGC Network
Paris, France
Ist. Tumori di Milano
Milan, Italy
Pauls Stradins Clinical University Hospital
Riga, Latvia
Erasmus Medisch Centrum Rotterdam
Rotterdam, Netherlands
Oslo University Hospital
Oslo, Norway
University of Edinburgh
Edinburgh, United Kingdom

Common questions

What is Lynch syndrome?

Lynch syndrome is an inherited condition that increases your risk of developing certain cancers, like bowel and womb cancer.

What are 'liquid biopsies'?

Liquid biopsies are simple tests performed on samples you can provide easily, like blood, urine, or stool, to look for signs of cancer.

Will I still need colonoscopies if I join?

Yes, colonoscopies are still a part of both study groups, but for some, the aim is to potentially reduce how often you need them.

Is this study safe?

The study aims to maintain effective cancer monitoring while exploring safer and less invasive methods. Any unusual test result will be followed up quickly.

What if I change my mind about participating?

You can withdraw from the study at any time without it affecting your medical care.

How to find out more

Amina Ghorbel, PhD

a-ghorbel@unicancer.fr +33 (0) 6 68 50 20 12 Official trial record

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