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The Clinical Utility of DNA Methylation Testing in Patient-collected Urine and Vaginal Samples to Detect Endometrial Cancer: a Case-control Study
Sponsor: University of Aarhus
Summary
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.
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.
Key Details
Gender
FEMALE
Age Range
60 Years - Any
Study Type
OBSERVATIONAL
Enrollment
120
Start Date
2025-04-15
Completion Date
2028-01-30
Last Updated
2026-01-26
Healthy Volunteers
Yes
Conditions
Interventions
DNA-methylation testing in patient-collected urine and vaginal samples
DNA-methylation testing of methylation markers CDO1, GHSR and ZIC1 for patient-collected vaginal samples and GHSR, CDH13 and SST for patient-collected urine samples.
Locations (3)
Department of Obstetrics and Gynaecology, Aarhus University Hospital
Aarhus N, Denmark
Department of Obstetrics and Gynaecology, Odense University Hospital
Odense, Denmark
Department of Orthopaedics, Randers Regional Hospital
Randers, Denmark