Actively Recruiting

FEMALE
NCT07400835

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

Led by University of Aarhus · Updated on 2026-05-13

600

Participants Needed

3

Research Sites

208 weeks

Total Duration

On this page

Sponsors

U

University of Aarhus

Lead Sponsor

C

Central Denmark Region

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official 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

Who Can Participate

FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Women with postmenopausal bleeding defined as vaginal bleeding after 12 months without periods undergoing evaluation for endometrial cancer
  • Treated in Central Denmark Region or Southern Denmark Region, Denmark
  • Able to provide written consent to participate
  • Able to read and understand Danish
Not Eligible

You will not qualify if you...

  • Having any other cancer diagnosis besides the evaluation for postmenopausal bleeding
  • Withdrawal of consent
  • Having had a hysterectomy

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Trial Site Locations

Total: 3 locations

1

Department of Obstetrics and Gynaecology, Aarhus University Hospital

Aarhus N, Denmark, 8200

Actively Recruiting

2

Department of Obstetrics and Gynaecology, Odense University Hospital

Odense, Denmark, 5000

Actively Recruiting

3

Department of Obstetrics and Gynaecology, Randers Regional Hospital

Randers, Denmark, 8930

Not Yet Recruiting

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Research Team

K

Karen O. Binderup

CONTACT

M

Mette Tranberg, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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