RecruitingNCT07400835

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


Sponsor

University of Aarhus

Enrollment

600 participants

Start Date

Feb 24, 2026

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Sex: FEMALE

Inclusion Criteria4

  • 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 Criteria3

  • Other concurrent cancer diagnosis besides diagnostic evaluation for postmenopausal bleeding
  • Withdrawal of consent
  • Hysterectomized

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Interventions

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

DNA-methylation testing of methylation markers CDO1, GHSR and ZIC1 for patient-collected vaginal samples, GHSR, CDH13 and SST for patient-collected urine samples and CDH13 + CDO1 + ZIC1 for clinician-collected cervical samples.


Locations(3)

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

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NCT07400835