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Recruiting NCT06846775

The Clinical Utility of DNA Methylation Testing in Patient-collected Urine and Vaginal Samples to Detect Endometrial Cancer: a Case-control Study

Trial Parameters

Condition Endometrial Cancer
Sponsor University of Aarhus
Study Type OBSERVATIONAL
Phase N/A
Enrollment 120
Sex FEMALE
Min Age 60 Years
Max Age N/A
Start Date 2025-04-15
Completion 2026-02-28
Interventions
DNA-methylation testing in patient-collected urine and vaginal samples

Brief 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.

Eligibility 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.

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