Using DNA testing on urine and vaginal samples to detect endometrial cancer
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.
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 |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 60 Years and up |
| Sex | Female |
| Sponsor | University of Aarhus Academic / other |
| Locations | 3 sites (Aarhus N and 2 other locations) |
| Trial ID | NCT06846775 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with other concurrent cancers or those who have undergone a hysterectomy will not benefit from this study.
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 performed: While there have been studies on DNA-methylation testing, this specific approach using patient-collected samples for endometrial cancer detection is relatively novel.
Eligibility criteria
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 this trial is running
Aarhus N and 2 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.