Tests DNA markers in urine, vaginal and cervical samples for endometrial cancer
Tests DNA markers in samples from women with bleeding after menopause.
Plain-language title generated from the registry record
Registry title: 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
Key facts
- Where
- Aarhus N, Odense, and Randers, DenmarkSee the 3 sites
Where in Denmark
- Department of Obstetrics and Gynaecology, Aarhus University HospitalAarhus N, DenmarkTaking people
- Department of Obstetrics and Gynaecology, Odense University HospitalOdense, DenmarkTaking people
- Department of Obstetrics and Gynaecology, Randers Regional HospitalRanders, DenmarkNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Aarhus
- Trial code
- NCT07400835
- Record updated
- 13 May 2026
- Original description
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:Read full original descriptionShow less
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
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.
Inclusion: 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: Other concurrent cancer diagnosis besides diagnostic evaluation for postmenopausal bleeding; Withdrawal of consent; Hysterectomized.