DNA methylation testing of urine, vaginal, and cervical samples to help detect endometrial cancer in women with postmenopausal bleeding.
Official title: The ENDOMETRIAL Study: EvaluatioN of DNA methylatiOn Markers for EndomeTrial Cancer Risk-stratification Using Patient-collected urIne and vAginal Samples and Clinician-collected Cervical Samples From Women With Postmenopausal bLeeding
Run by University of Aarhus · NCT07400835 · Data updated 2026-11-12
This project tests whether DNA methylation tests on self-collected urine and vaginal samples and clinician-collected cervical samples can help detect endometrial cancer in women with postmenopausal bleeding.
Quick facts
| Study type | Observational |
|---|---|
| Sex | Women only |
| Enrollment | 600 (estimated) |
| Sponsor | University of Aarhus Academic / other |
| Locations | 3 sites (Aarhus N and 2 other locations) |
| Status | Recruiting |
| Started | February 24, 2026 |
| Main results expected | February 24, 2028 |
| Study ends | February 24, 2030 |
| Registry record updated | May 13, 2026 |
| Trial ID | NCT07400835 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women with postmenopausal bleeding who are undergoing diagnostic evaluation at participating gynecology departments in Central or Southern Denmark, can provide informed consent, read Danish, and have not had a hysterectomy.
✕Probably not a fit
Women who have had a hysterectomy, have another concurrent cancer diagnosis, cannot provide consent or samples, or live outside the participating regions are unlikely to be eligible or to benefit from this approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study compares DNA methylation testing on patient-collected urine and vaginal samples and clinician-collected cervical samples with the standard diagnostic pathway using transvaginal ultrasound (TVUS) and, when indicated, endometrial biopsy. Women with postmenopausal bleeding at participating centers in Central and Southern Denmark provide self-collected samples alongside routine clinical evaluation, and results are linked to histopathology and clinical follow-up. Researchers will measure diagnostic accuracy of methylation tests versus TVUS and track two-year cancer outcomes for women with different test results. The approach aims to determine whether adding methylation testing can improve triage and reduce unnecessary invasive procedures.
Why it matters
Potential benefit: If successful, methylation testing could enable simple self-sampling that reduces unnecessary invasive biopsies and speeds up diagnosis for symptomatic women.
How similar studies have gone: Previous smaller studies of DNA methylation markers for endometrial cancer have shown promising accuracy, but large-scale validation using patient-collected urine and vaginal samples is still limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Postmenopausal bleeding (defined as vaginal bleeding after absence of periods for ≥ 12 months) undergoing diagnostic evaluation for EC at gynaecological departments * Treated in Central Denmark Region or Southern Denmark Region, Denmark * Able to provide written consent for participation * Able to read and understand Danish Exclusion Criteria: * Other concurrent cancer diagnosis besides diagnostic evaluation for postmenopausal bleeding * Withdrawal of consent * Hysterectomized
Where it's running
-
Department of Obstetrics and Gynaecology, Aarhus University Hospital
Aarhus N, Denmark Recruiting -
Department of Obstetrics and Gynaecology, Odense University Hospital
Odense, Denmark Recruiting -
Department of Obstetrics and Gynaecology, Randers Regional Hospital
Randers, Denmark Not yet recruiting
Study contacts
- Principal investigator: Mette Tranberg, PhD — University Clinic for Cancer Screening, Department of Public Health Programmes, Randers Regional Hospital
- Study coordinator: Karen O. Binderup
- Email: kabind@rm.dk
- Phone: +4524656562
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.