NCT07400835Recruiting
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
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
Source: ClinicalTrials.gov · Last updated 13 May 2026
Brief summary (registry, in English)
The goal of this observational study is to investigate the clinical utility of DNA-methylation testing in urine and vaginal samples collected by patients and cervical samples collected by clinicians, to determine the risk of endometrial cancer in symptomatic women with postmenopausal bleeding. The study aims to answer the following research questions: * What is the diagnostic accuracy of DNA methylation testing in urine, vaginal and cervical samples compared to traditional TVUS for endometrial cancer detection? * What is the 2-year risk of EC among women testing negative on TVUS and/or DNA methylation tests or those testing positive on methylation only? Researchers will compare DNA methylation testing in patient-collected urine and vaginal samples as well as in clinician-collected cervical samples, with the traditional diagnostic pathway for women with PMB, which includes TVUS evaluation, and when indicated by abnormal TVUS findings, endometrial biopsy according to clinical guidelines. Participants will * take a urine and vaginal sample * have a cervical sample collected by a clinician * undergo TVUS evaluation according to clinical guidelines * If TVUS shows thickened endometrium (≥ 5 mm) and/or irregularity, an endometrial biopsy will be collected according to clinical guidelines * fill out a questionnaire regarding acceptability and preferences of sampling methods and complete a lifestyle questionnaire.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 600 (estimated)
- First submitted
- 3 Feb 2026
- Start date
- 24 Feb 2026
- Primary completion date
- 24 Feb 2028
- Lead sponsor
- University of Aarhus
- Diseases
- Endometrial cancer, Childhood cancers
- NCT number
- NCT07400835
What you commit to
- Study type: Observational
- Planned participants: 600
- From 24 Feb 2026 to the primary completion date, 24 Feb 2028
- 3 sites 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.
Prior treatment
- Other concurrent cancer diagnosis besides diagnostic evaluation for postmenopausal bleeding
Other
- Withdrawal of consent
- Hysterectomized
Who the study is looking for
- 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
Sex: Female · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Obstetrics and Gynaecology, Aarhus University Hospital Coordinator of this site? Confirm its status | Aarhus N | Denmark | Recruiting |
| Department of Obstetrics and Gynaecology, Odense University Hospital Coordinator of this site? Confirm its status | Odense | Denmark | Recruiting |
| Department of Obstetrics and Gynaecology, Randers Regional Hospital Coordinator of this site? Confirm its status | Randers | Denmark | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.