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NOT YET RECRUITING
NCT07360834
NA

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

Sponsor: UNICANCER

View on ClinicalTrials.gov

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.

Official title: Predicting Cancer Onset in Lynch Syndrome by Liquid Biopsies

Key Details

Gender

All

Age Range

35 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

2000

Start Date

2026-04-01

Completion Date

2030-12-01

Last Updated

2026-01-23

Healthy Volunteers

No

Conditions

Interventions

DIAGNOSTIC_TEST

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

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