Actively Recruiting
The Clinical Utility of DNA Methylation Testing in Patient-collected Urine and Vaginal Samples to Detect Endometrial Cancer: a Case-control Study
Led by University of Aarhus · Updated on 2026-01-26
120
Participants Needed
3
Research Sites
145 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 case-control study is to investigate the use of DNA-methylation testing in patient-collected urine and vaginal samples to detect endometrial cancer. The study aims to answer the following questions: * Can DNA methylation testing in vaginal and full-void urine samples distinguish endometrial cancer cases from healthy controls? Researchers will compare patient-collected urine and vaginal samples from patients with diagnosed endometrial cancer (cases) to gynaecologically and oncologically healthy controls (controls). Participants will * take a urine and vaginal sample at the hospital. * answer a questionnaire regarding acceptability and preferences of self-sampling methods. * answer a lifestyle questionnaire.
CONDITIONS
Official Title
The Clinical Utility of DNA Methylation Testing in Patient-collected Urine and Vaginal Samples to Detect Endometrial Cancer: a Case-control Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 60 years or older
- Diagnosed with cancer of the uterus lining (endometrial cancer) for cases
- Postmenopausal women aged 60 years or older for healthy controls
- Living in Central Denmark Region or Southern Denmark Region (cases) or Central Denmark Region (controls)
- Able to provide written consent for participation
- Able to read and understand Danish
You will not qualify if you...
- Having another cancer diagnosis besides endometrial cancer (cases)
- Withdrawal of consent
- Diagnosed with cancer or undergoing diagnostic assessment in the last 5 years (controls)
- Vaginal bleeding within the last 3 months (controls)
- Known gynecological diseases such as cervical dysplasia or atypical endometrial hyperplasia within the last 5 years (controls)
- Previously had a hysterectomy (controls)
AI-Screening
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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 Orthopaedics, Randers Regional Hospital
Randers, Denmark, 8930
Actively 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
2
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