DNA methylation testing of urine, vaginal, and cervical samples to help detect endometrial cancer in women with postmenopausal bleeding.
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
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 |
|---|---|
| Enrollment | 600 (estimated) |
| Sex | Female |
| Sponsor | University of Aarhus Academic / other |
| Locations | 3 sites (Aarhus N and 2 other locations) |
| Trial ID | NCT07400835 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Aarhus N and 2 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.