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

NCT07400835 | Recruiting

• 1 other identifier: endometrial-PMB-stúdy
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 3

Brief 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

Keywords

DNA methylation; Postmenopausal bleeding; Endometrial Cancer; Patient-collected urine samples; cervical samples; Patient-collected vaginal samples

Outcome Measures

Primary Outcomes (1)

• 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.

  At the time of enrollment and to the time of diagnosis

Study Arms (1)

Women with postmenopausal bleeding

Women referred for diagnostic evaluation to gynaecological departments for endometrial cancer due to postmenopausal bleeding

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

Interventions

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

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.

Women with postmenopausal bleeding

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women with postmenopausal bleeding undergoing diagnostic evaluation for endometrial cancer will be recruited from Department of Obstetrics and Gynaecology, Aarhus University Hospital, Randers Regional Hospital, Central Denmark Region, and Odense University Hospital, Southern Denmark Region, Denmark.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Aarhus: lead
• Central Denmark Region: collaborator
• University of Southern Denmark: collaborator
• Region of Southern Denmark: collaborator
• Amsterdam UMC: collaborator
• Aarhus University Hospital: collaborator
• Randers Regional Hospital: collaborator

Study Sites (3)

Department of Obstetrics and Gynaecology, Aarhus University Hospital

Aarhus N, 8200, Denmark

RECRUITING

Department of Obstetrics and Gynaecology, Odense University Hospital

Odense, 5000, Denmark

RECRUITING

Department of Obstetrics and Gynaecology, Randers Regional Hospital

Randers, 8930, Denmark

NOT YET RECRUITING

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Biospecimen

Retention: SAMPLES WITH DNA

Patient-collected urine and vaginal samples, and clinician-collected cervical samples.

MeSH Terms

Conditions

Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Mette Tranberg, PhD

  University Clinic for Cancer Screening, Department of Public Health Programmes, Randers Regional Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karen O. Binderup

CONTACT

+4524656562; kabind@rm.dk

Mette Tranberg, PhD

CONTACT

+4578420264; mettrani@rm.dk

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2026
• First Posted: February 10, 2026
• Study Start: February 24, 2026
• Primary Completion (Estimated): February 24, 2028
• Study Completion (Estimated): February 24, 2030
• Last Updated: May 13, 2026

Record last verified: 2026-02

Locations

DK (3)