NCT06846775Recruiting
The Clinical Utility of DNA Methylation Testing in Patient-collected Urine and Vaginal Samples to Detect Endometrial Cancer: a Case-control Study
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.
Source: ClinicalTrials.gov · Last updated 26 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 120 (estimated)
- First submitted
- 20 Feb 2025
- Start date
- 15 Apr 2025
- Primary completion date
- 28 Feb 2026
- Lead sponsor
- University of Aarhus
- Diseases
- Endometrial cancer
- NCT number
- NCT06846775
What you commit to
- Study type: Observational
- Planned participants: 120
- From 15 Apr 2025 to the primary completion date, 28 Feb 2026
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- 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.
Age in the registry: 60 years to - · Sex: Female · Accepts healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Obstetrics and Gynaecology, Aarhus University Hospital Coordinator of this site? Confirm its status | Aarhus N | Denmark | Recruiting |
| Department of Obstetrics and Gynaecology, Odense University Hospital Coordinator of this site? Confirm its status | Odense | Denmark | Recruiting |
| Department of Orthopaedics, Randers Regional Hospital Coordinator of this site? Confirm its status | Randers | Denmark | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.