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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

NCT07400835ENROLLING_BY_INVITATIONOBSERVATIONAL

Summary

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.

Key Facts

Lead Sponsor

University of Aarhus

Enrollment

600

Start Date

2026-02-02

Completion Date

2028-02-02

Study Type

OBSERVATIONAL

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

Interventions

DNA-methylation testing in patient-collected urine and vaginal samples and clinician-collected cervical samples

Conditions

Postmenopausal Bleeding

Eligibility

Sex

FEMALE

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

Outcome Measures

Primary Outcomes

Area under the Curve (AUC)

The performance of each methylation marker panels in urine, vaginal and cervical samples and the TVUS will be evaluated by area Under the Curve with 95% CIs.

Time frame: At the time of enrollment and to the time of diagnosis

Locations

Department of Obstetrics and Gynaecology, Aarhus University Hospital, Aarhus N, Denmark

Department of Obstetrics and Gynaecology, Odense University Hospital, Odense, Denmark

Department of Obstetrics and Gynaecology, Randers Regional Hospital, Randers, Denmark