Actively Recruiting
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
Eligibility Criteria
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
You will not qualify if you...
- Having any other cancer diagnosis besides the evaluation for postmenopausal bleeding
- Withdrawal of consent
- Having had a hysterectomy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
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
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here