An observational study in Lynch Syndrome, sponsored by University of Edinburgh. Not yet recruiting at 1 site in United Kingdom. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by University of Edinburgh · Observational
Lynch syndrome is the most common inherited condition that raises a person's risk of getting certain cancers. It happens because of changes in genes that normally fix damaged DNA. People with Lynch syndrome have a higher chance over their lifetime of cancers like bowel, womb (endometrial), ovarian, and others.
For people with a uterus, cancer of the womb lining (endometrial cancer) is often the first cancer to appear, affecting over 40% of some groups.
Even though the risk is high, the current ways of checking for endometrial cancer aren't ideal. They often involve uncomfortable and invasive tests, like taking tissue samples (biopsies) or internal scans. These can be expensive and don't always catch cancer early, so many people don't keep up with regular checks.
New methods are being developed that look for tiny amounts of cancer DNA in easy, non-invasive samples, like urine or self-collected vaginal swabs. These approaches could make testing easier, more comfortable, and possibly just as accurate.
The PREDI-ENDO study will compare these simple tests (urine and self-collected swabs) with the standard, more invasive tests. It will include people with Lynch syndrome, those who may have symptoms, and those who would rather avoid invasive procedures. Researchers will also compare different types of samples to see which works best.
About 400 women across around 20 sites in the UK will be asked to take part. They'll do these new tests alongside their usual hospital tests to see if screening can be made easier and better.
The goal is to develop safer, simpler, and more reliable ways to find cancer early, and possibly replace the current invasive tests in the future.
141 studies on the registry are indexed under Colorectal Neoplasms, Hereditary Nonpolyposis; 60 are open to participants now.
This study's planned enrollment of 1,450 is above the median of 400 across 60 observational studies indexed under Colorectal Neoplasms, Hereditary Nonpolyposis.
Browse Colorectal Neoplasms, Hereditary Nonpolyposis studies →University of Edinburgh is the lead sponsor of 403 studies on the registry; 65 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Women with Lynch syndrome with a uterus who are at a higher risk of uterine cancer.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Confirmed Lynch syndrome and a uterus. Research samples are collected at agreed visits alongside usual care where possible.
Confirmed Lynch syndrome and a uterus. Routine invasive screening is declined or unavailable. Outcome follow-up uses medical records and/or cancer registry records.
Confirmed MMRd womb cancer. Lynch syndrome is not required. Feasible samples and available routine tissue support laboratory test development.
To define the diagnostic accuracy of non-invasive surveillance approaches for EC detection and assess non-inferiority to standard surveillance using invasive modalities.
Non-inferiority of the diagnostic accuracy of non-invasive surveillance approaches for EC detection in individuals with LS compared to standard practice invasive modalities.
Time frame: 36 months
To define diagnostic sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and yield of each screening test.
Diagnostic sensitivity, specificity, PPV, NPV, and yield of each screening test.
Time frame: 36 months
To assess the association between screening and clinicopathological features of the tumours, to understand the biology or clinical features of interval cancers missed by screening as well as the impact of screening on tumour stage.
Clinicopathological features of interval (detected between screening tests) and incident (detected by screening) EC, including tumour MMR status, tumour location in the endometrium, tumour stage and grade, etc.
Time frame: 36 months
To determine the feasibility, acceptability, and referral outcomes of annual non-invasive surveillance
Number and type of follow-up interventions triggered by surveillance.
Time frame: 36 months
To identify barriers to and ways of optimising surveillance compliance, including integration of at-home self-sampling into surveillance protocols.
Changes in QoL questionnaires and symptom checklist over time.
Time frame: 36 months
To model the cost-effectiveness of the non-invasive approach and invasive approach.
Incremental cost per case detected and QALY gains.
Time frame: 36 months
To validate an extended MSI-Plus panel for EC early detection from uDNA or vsDNA analysis.
Diagnostic sensitivity of MSI-Plus enhanced for EC detection from uDNA and vsDNA.
Time frame: 36 months
To develop and validate molecular classifiers for EC using multi-omic data from Ellele samples. This will include assessment of tumour shedding patterns and identification of novel molecular biomarkers predictive of disease (50 participants.
Multi-omic molecular classifier for EC detection from Ellele samples (50 participants).
Time frame: 12 months
Documents are hosted by the registry — open the source record to download them.
Plan to share: Undecided
Start is estimated for Oct 2026; primary completion for Oct 2029, 36 months later.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Colorectal Neoplasms, Hereditary Nonpolyposis →