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

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.

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Key information

Conditions

Lynch Syndrome Colonic Diseases Colorectal Neoplasms Colorectal Neoplasms, Hereditary Nonpolyposis Congenital, Hereditary, and Neonatal Diseases and Abnormalities DNA Repair-Deficiency Disorders Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Genetic Diseases, Inborn Intestinal Diseases Intestinal Neoplasms Metabolic Diseases Neoplasms Neoplasms by Site Neoplastic Syndromes, Hereditary Nutritional and Metabolic Diseases Turcot syndrome

Age range

35 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Klinicki Bolnicki Centar Sestre Milosrdnice Ustanova, Zagreb, Croatia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.
Age 35-80
Genetically confirmed class 4-5 (likely pathogenic (LP) or pathogenic (P) variant, respectively) in MLH1, MSH2, MSH6, or EPCAM gene.
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

Previously performed proctocolectomy or equivalent (entire colon and rectum removed)
Active treatment for cancer within 2 years prior to inclusion.
Checkpoint inhibitor therapy within 12 months
Pregnancy
Participants unwilling or unable to comply with the medical follow-up required by the trial because of geographic, familial, social, or psychological reasons.
Persons deprived of their liberty or under protective custody or guardianship.

Treatment and study plan

INVITRO DIAGNOSTIC TESTS AND COLONOSCOPY

Diagnostic Test

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

Primary outcomes

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

Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Amina Ghorbel, PhD

CONTACT

[email protected]

+33 (0) 6 68 50 20 12

Sponsors and collaborators

Lead sponsor

UNICANCER

Other

Registry information

Official study title

Predicting Cancer Onset in Lynch Syndrome by Liquid Biopsies

Acronym: PREDI-LYNCH

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2030
First posted: Jan 22, 2026
Registry last updated: Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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