Using DNA testing on urine and vaginal samples to detect endometrial cancer
Official title: A Case-control Study of the Clinical Utility of DNA Methylation Testing in Patient-collected Vaginal and Urine Samples: A Novel, Patient-friendly and Simple Diagnostic Solution to Detect Endometrial Cancer.
Run by University of Aarhus · NCT06846775 · Data updated 2026-11-12
This study is testing whether DNA testing on urine and vaginal samples can help find endometrial cancer earlier in women compared to healthy individuals.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 60 Years and up |
| Sex | Women only |
| Enrollment | 120 (estimated) |
| Sponsor | University of Aarhus Academic / other |
| Locations | 3 sites (Aarhus N and 2 other locations) |
| Status | Recruiting |
| Started | April 15, 2025 |
| Main results expected | February 28, 2026 |
| Study ends | January 30, 2028 |
| Registry record updated | January 26, 2026 |
| Trial ID | NCT06846775 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include postmenopausal women aged 60 and older, either diagnosed with endometrial cancer or healthy controls living in Central Denmark or Southern Denmark.
✕Probably not a fit
Patients with other concurrent cancers or those who have undergone a hysterectomy will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational case-control study aims to evaluate the effectiveness of DNA-methylation testing on patient-collected urine and vaginal samples for detecting endometrial cancer. Researchers will compare samples from women diagnosed with endometrial cancer to those from healthy controls to determine if the testing can accurately distinguish between the two groups. Participants will provide samples at the hospital and complete questionnaires regarding their experiences and lifestyle. The study seeks to improve early detection methods for endometrial cancer, which currently lacks effective screening.
Why it matters
Potential benefit: If successful, this study could lead to a non-invasive and accurate method for early detection of endometrial cancer, potentially improving patient outcomes.
How similar studies have gone: While there have been studies on DNA-methylation testing, this specific approach using patient-collected samples for endometrial cancer detection is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Patients with endometrial cancer (cases): Inclusion Criteria: * Women ≥ 60 years * Diagnosed with cancer corpus uteri * Living in Central Denmark Region or Southern Denmark Region, Denmark * Able to provide written consent for participation * Able to read and understand Danish Patients with endometrial cancer (cases): Exclusion Criteria: * Other concurrent cancer diagnosis besides cancer corpus uteri * Withdrawal of consent Healthy controls: Inclusion Criteria: * Postmenopausal women ≥ 60 years * Living in Central Denmark Region, Denmark * Able to provide written consent for participation * Able to read and understand Danish Healthy controls: Exclusion Criteria: * Diagnosed with cancer or undergoing diagnostic assessment herfore without the last 5 years. * Vaginal bleeding within the last 3 months. * Known gynaecological diseases such as cervical dysplasia or atypical endomatrial hyperplasia within the last 5 years. * Previously hysterectomized * Withdrawal of consent.
Where it's running
-
Department of Obstetrics and Gynaecology, Aarhus University Hospital
Aarhus N, Denmark Recruiting -
Department of Obstetrics and Gynaecology, Odense University Hospital
Odense, Denmark Recruiting -
Department of Orthopaedics, Randers Regional Hospital
Randers, Denmark Recruiting
Study contacts
- Principal investigator: Mette Tranberg — University Research Clinic for Cancer Screening, Department of Public Health Programmes, Randers Regional Hospital
- Study coordinator: Karen O. Binderup
- Email: kabind@rm.dk
- Phone: +4578420187
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.