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ClinicalTrials.gov ID

NCT07360834

Lead Sponsor

UNICANCEROTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

2,000Estimated

Last Update Posted

Aug 3, 2026Actual

Start Date

Dec 1, 2026Estimated

Primary Completion Date

Dec 1, 2027Estimated

Completion Date

Dec 1, 2030Estimated

Official Title

Predicting Cancer Onset in Lynch Syndrome by Liquid Biopsies

Brief Summary

Lynch syndrome is an inherited genetic predisposition that increases the risk of developing several types of cancer, particularly colon and rectal cancers (colorectal cancer), as well as cancer of the uterine lining (endometrial cancer). It affects around 1 in 400 people in Europe.

Today, surveillance mainly relies on examinations such as colonoscopy (an examination of the colon using a camera) or gynaecological evaluations, sometimes accompanied by biopsies (the removal of a small tissue sample for microscopic analysis). Although effective, these procedures are invasive and demanding; they can affect quality of life and discourage some individuals from adhering to their recommended surveillance programme.

The European project PREDI-LYNCH is exploring an additional pathway that is simpler and better tolerated. This project relies on "liquid biopsies", meaning tests performed on easily collected samples such as blood, urine, stool, and vaginal swabs for women with a uterus. The PREDI-LYNCH study aims to determine whether these non-invasive tests could enable personalised surveillance and potentially increase the interval between more burdensome procedures, while maintaining a high level of medical safety.

Detailed Description

This European clinical study evaluates whether non-invasive liquid biopsy tests (blood, urine, stool and vaginal samples when applicable) can improve cancer surveillance in adults with genetically confirmed Lynch syndrome (MLH1, MSH2, MSH6 or EPCAM). The trial compares two strategies: standard follow-up with colonoscopy every 18 months versus an approach combining annual liquid biopsies with a colonoscopy every 36 months. The main outcome is the number of new cancer cases diagnosed, confirmed by standard procedures. Secondary outcomes include early cancer detection, lesion identification, diagnostic timing, feasibility, quality of life and healthcare use. Each positive test leads to fast confirmatory exams. The aim is to determine if liquid biopsies can safely reduce invasive procedures while maintaining effective cancer monitoring.

• Lynch Syndrome

• INVITRO DIAGNOSTIC TESTS AND COLONOSCOPY

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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.

Primary Purpose

Prevention

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

UNICANCEROTHER

msvoboda@mou.cz+420 543 134 103

toni.seppala@tuni.fi+358444722846

a-ghorbel@unicancer.fr0668502012

marco.vitellaro@istitutotumori.mi.it+39 02.2390 2540

arvids.irmejs@rsu.lv+371 29171604

a.wagner@erasmusmc.nl0031107036913

m.l.hoivik@medisin.uio.no+47 924 37 392

neil.ryan@ed.ac.uk+1 778 223 9770