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Liquid biopsies may let lynch syndrome patients skip half their colonoscopies

NCT ID NCT07360834

Diagnosis Sponsor: UNICANCER Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 04, 2026 · Updated 3 times

Summary

This study tests whether annual liquid biopsies (from blood, urine, stool, and vaginal swabs) can safely replace colonoscopies every 18 months for people with Lynch syndrome. 2,000 participants will be split into two groups: one gets standard care (colonoscopy every 18 months), the other gets liquid biopsies plus a colonoscopy every 36 months. The goal is to see if the liquid biopsy approach catches cancers just as early, while being less invasive and more convenient.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
liquid biopsy (blood, urine, stool, vaginal swab) and colonoscopy
What this could lead to
If successful, this could allow people with Lynch syndrome to have fewer invasive colonoscopies while still catching cancers early, improving quality of life.
What could go wrong
This is a large but early-stage study that has not yet started recruiting. Liquid biopsies may miss some early cancers, and the approach must prove it is as safe as standard care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 2,000 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Dec 2026

An estimate. Start dates often move.

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

35 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Participant must have signed a written informed consent prior to any trial specific procedures. When the patient is physically unable to give their written consent, a trusted person of their choice, independent from the investigator or the sponsor, can confirm in writing the patient's consent. 2. Age 35-80 3. Genetically confirmed class 4-5 (likely pathogenic (LP) or pathogenic (P) variant, respectively) in MLH1, MSH2, MSH6, or EPCAM gene. 4. The participant should be insurance covered for the financial costs of the standard surveillance and healthcare related to LS, such as affiliated to Social Security System Exclusion Criteria: 1. Previously performed proctocolectomy or equivalent (entire colon and rectum removed) 2. Active treatment for cancer within 2 years prior to inclusion. 3. Checkpoint inhibitor therapy within 12 months 4. Pregnancy 5. Participants unwilling or unable to comply with the medical follow-up required by the trial because of geographic, familial, social, or psychological reasons. 6. Persons deprived of their liberty or under protective custody or guardianship.

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Conditions

The condition(s) this trial relates to.

Colorectal Neoplasms, Hereditary Nonpolyposis Lynch syndrome mismatch repair cancer syndrome 1

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Lynch syndrome

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    9 sites in 9 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Erasmus Medisch Centrum Rotterdam

    Rotterdam, Netherlands

  • GGC Network

    Paris, France

  • Ist. Tumori di Milano

    Milan, Italy

  • Klinicki Bolnicki Centar Sestre Milosrdnice Ustanova

    Zagreb, Croatia

  • Masaryk Memorial Cancer Institute

    Brno, Czechia

  • Oslo University Hospital

    Oslo, Norway

  • Pauls Stradins Clinical University Hospital

    Riga, Latvia

  • Tampereen Korkeakoulusäätiö SR

    Helsinki, Finland

  • University of Edinburgh

    Edinburgh, United Kingdom

More trials for these conditions

Other studies related to the condition(s) this trial covers.