An interventional study of INVITRO DIAGNOSTIC TESTS AND COLONOSCOPY in Lynch Syndrome, sponsored by UNICANCER. Not yet recruiting at 9 sites in 9 countries. Open to participants aged 35 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-08-03.
Sponsored by UNICANCER · Not applicable, Interventional, and Prevention
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.
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.
145 studies on the registry are indexed under Colorectal Neoplasms, Hereditary Nonpolyposis; 59 are open to participants now.
This study's planned enrollment of 2,000 is above the median of 200 across 75 interventional studies indexed under Colorectal Neoplasms, Hereditary Nonpolyposis.
Browse Colorectal Neoplasms, Hereditary Nonpolyposis studies →UNICANCER is the lead sponsor of 219 studies on the registry; 52 are open to participants now.
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsies Liquids +/- Colonoscopy
Diagnostic Test: INVITRO DIAGNOSTIC TESTS AND COLONOSCOPY
Colonoscopy each 18 months
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
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
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.
Time frame: Baseline, month 12, month 24, month 36, month 48
Plan to share: No
Start is estimated for Dec 2026; primary completion for Dec 2027, 12 months later.
Of 37 interventional studies with no phase under Colorectal Neoplasms, Hereditary Nonpolyposis, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 27 and three quarters within 86. This study's planned 12 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Colorectal Neoplasms, Hereditary Nonpolyposis →