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

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.

Conditions

• Postmenopausal Bleeding

Interventions

DIAGNOSTIC_TEST

DNA-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.

Sponsors & Collaborators

• Central Denmark Region

  collaborator OTHER

• University of Southern Denmark

  collaborator OTHER

• Randers Regional Hospital

  collaborator OTHER

• Region of Southern Denmark

  collaborator OTHER

• Amsterdam UMC

  collaborator OTHER

• Aarhus University Hospital

  collaborator OTHER

• University of Aarhus

  lead OTHER

Principal Investigators

• Mette Tranberg, PhD · University Clinic for Cancer Screening, Department of Public Health Programmes, Randers Regional Hospital

Eligibility

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-02-24

Primary Completion

2028-02-24

Completion

2030-02-24

Countries

• Denmark

Study Locations