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

NCT07360834 · tracked via the Priya Life Science Netherlands tracker

Sponsor

UNICANCER

Phase

Not applicable

Started

2026-12-01

Last updated

2026-08-03

Condition(s) studied

Lynch Syndrome

Investigational drug(s) / intervention(s)

INVITRO DIAGNOSTIC TESTS AND COLONOSCOPY

INVITRO DIAGNOSTIC TESTS AND COLONOSCOPY: 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

Study 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.

Eligibility

Sex

ALL

Min age

35 Years

Max age

80 Years

Healthy volunteers

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 outcome measure(s)

To determine whether a multimodal surveillance strategy - using combining concurrent circulating tumor DNA (ctDNA), urine tumor DNA (utDNA), vaginal swab tumor DNA (vsDNA), and stool (qFIT) - is non-inferior to standard-of-care screening surveillance — Baseline, month 12, month 24, month 36, month 48
Number of newly diagnosed histologically confirmed invasive cancers (CRC, EC, UC) during surveillance and follow-up phases, expressed as cumulative incidence (%) and incidence per 1,000 person-years.

Trial sites (9)

Facility	City	Region
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

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Other trials for the same condition

Preventive Dendritic Cell Vaccination for Lynch Syndrome Carriers Starting soon

The GEOLynch Cohort Study Recruiting

Preventive Dendritic Cell Vaccination for Lynch Syndrome Starting soon

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07360834 on ClinicalTrials.gov ↗ ← All trials in the Netherlands