NCT07360834Not yet recruiting
Study Aiming to Test Whether Non-invasive Liquid Biopsies Can Safely Reduce Invasive Surveillance Methods in Lynch Syndrome
Predicting Cancer Onset in Lynch Syndrome by Liquid Biopsies
Source: ClinicalTrials.gov · Last updated 3 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 2000 (estimated)
- First submitted
- 13 Jan 2026
- Start date
- Dec 2026
- Primary completion date
- Dec 2027
- Lead sponsor
- UNICANCER
- NCT number
- NCT07360834
What you commit to
- Study type: Interventional
- Planned participants: 2000
- From Dec 2026 to the primary completion date, Dec 2027
- 9 sites in 9 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other
- 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.
Who the study is looking for
- 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
Age in the registry: 35 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (9)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Masaryk Memorial Cancer Institute Coordinator of this site? Confirm its status | Brno | Czechia | Unknown status |
| Tampereen Korkeakoulusäätiö SR Coordinator of this site? Confirm its status | Helsinki | Finland | Unknown status |
| GGC Network Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| University of Edinburgh Coordinator of this site? Confirm its status | Edinburgh | United Kingdom | Unknown status |
| Klinicki Bolnicki Centar Sestre Milosrdnice Ustanova Coordinator of this site? Confirm its status | Zagreb | Croatia | Unknown status |
| Ist. Tumori di Milano Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Pauls Stradins Clinical University Hospital Coordinator of this site? Confirm its status | Riga | Latvia | Unknown status |
| Erasmus Medisch Centrum Rotterdam Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Unknown status |
| Oslo University Hospital Coordinator of this site? Confirm its status | Oslo | Norway | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.