Lynch SyndromePREDI-ENDONCT07877779
Protocol for Non-invasive Gynaecological Surveillance in Lynch Syndrome
An observational study of Lynch Syndrome, run by University of Edinburgh at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Lynch Syndrome
- How many people
- 1,450 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 16 Oct 2026to 1 Jan 2031
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women with Lynch syndrome with a uterus who are at a higher risk of uterine cancer.
Who may be able to join
- 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.
Who cannot join
- Pregnancy at enrolment.
- 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.
- 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 another interventional trial for urogenital cancer risk or surveillance that would conflict with PREDI-ENDO procedures or interpretation.
- Participation in the main PREDI-LYNCH multicancer liquid-biopsy and colonoscopy trial
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Lauren C Sutherland, MSc contact
United Kingdom1 site
NHS Lothian
Edinburgh, Scotland, EH16 4UU
Ann M Doust, 07810643488, ann.doust@ed.ac.uk
Lauren Sutherland, MSc, lauren.sutherland@ed.ac.uk
About this study
Official title: PREDI-ENDO: Protocol for Non-invasive Gynaecological Surveillance in Lynch Syndrome
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.
Read more
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.
- Conditions
- Lynch Syndrome
- Keywords
- Lynch syndrome, endometrial cancer
- Medical subject headings
- Colorectal Neoplasms, Hereditary Nonpolyposis, Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Active Lynch syndrome cohort | Confirmed Lynch syndrome and a uterus. Research samples are collected at agreed visits alongside usual care where possible. | |
| Minimal-contact Lynch syndrome cohort | Confirmed Lynch syndrome and a uterus. Routine invasive screening is declined or unavailable. Outcome follow-up uses medical records and/or cancer registry records. | |
| MMRd womb cancer validation cohort | Confirmed MMRd womb cancer. Lynch syndrome is not required. Feasible samples and available routine tissue support laboratory test development. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 36 months
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 36 months
To model the cost-effectiveness of the non-invasive approach and invasive approach.
Incremental cost per case detected and QALY gains.
Measured: 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.
Measured: 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).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2026
- Study start16 Oct 2026 (estimated)
- Primary completion30 Oct 2029 (estimated)
- Study completion1 Jan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lynch SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Lothian
- Responsible party
- Sponsor
- Investigators
- Neil Ryan, MD, Principal investigator, University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07877779
- Sponsor's protocol ID
- AC26070
- Acronym
- PREDI-ENDO
- Status last verified
- Oct 2026
- First submitted
- 9 Oct 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided