NCT07877779Not yet recruiting
Protocol for Non-invasive Gynaecological Surveillance in Lynch Syndrome
PREDI-ENDO: Protocol for Non-invasive Gynaecological Surveillance in Lynch Syndrome
Source: ClinicalTrials.gov · Last updated 22 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 1450 (estimated)
- First submitted
- 9 Oct 2026
- Start date
- 16 Oct 2026
- Primary completion date
- 30 Oct 2029
- Lead sponsor
- University of Edinburgh
- Diseases
- Endometrial cancer
- NCT number
- NCT07877779
What you commit to
- Study type: Observational
- Planned participants: 1450
- From 16 Oct 2026 to the primary completion date, 30 Oct 2029
- 1 site in 1 country
- 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.
Other illness
- For the Lynch syndrome surveillance cohorts: active urogenital cancer at enrolment. This does not exclude participants with confirmed MMRd endometrial cancer from the separately defined cancer validation cohort.
- Participation in another interventional trial for urogenital cancer risk or surveillance that would conflict with PREDI-ENDO procedures or interpretation.
Other
- Pregnancy at enrolment.
- For an active sampling pathway requiring a vaginal sample: inability to provide that sample for anatomical or clinical reasons. This does not exclude an otherwise eligible participant from the minimal-contact cohort or from a feasible sample pathway discussed with the clinical and research team.
- Participation in the main PREDI-LYNCH multicancer liquid-biopsy and colonoscopy trial
Who the study is looking for
- Age ≥18yrs with no upper limit
- Uterus in situ at enrolment
- Ability to provide informed consent
- For Lynch syndrome active surveillance and minimal-contact cohorts: clinically confirmed Lynch syndrome, verified through medical records and/or a clinical genetics report.
- For the MMRd endometrial cancer validation cohort: clinically confirmed mismatch repair deficient endometrial cancer, diagnosed by specialist pathology review, mismatch repair immunohistochemistry and/or clinically validated microsatellite instability testing.
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| NHS Lothian Coordinator of this site? Confirm its status | Edinburgh | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.