Clinical Trial

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

Study acronym: PREDI-LYNCH
Not Yet Recruiting
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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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-01-13.
Trial Details
NCT Number NCT07360834
Lead Sponsor UNICANCER
Conditions Lynch Syndrome
Enrollment 2,000 participants
Start Date 2026-12-01
Primary Completion 2027-12-01 (estimated)
Study Completion 2030-12-01 (estimated)
Updated on ClinicalTrials.gov 2026-08-03