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Evaluation of DNA Methylation Markers for Endometrial Cancer Risk-stratification Using Patient-collected Urine and Vaginal Samples and Clinician-collected Cervical Samples From Women With Postmenopausal Bleeding

Recruitingn/aAges any - anyFemaleUniversity of Aarhus
NCT07400835 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The goal of this observational study is to investigate the clinical utility of DNA-methylation testing in urine and vaginal samples collected by patients and cervical samples collected by clinicians, to determine the risk of endometrial cancer in symptomatic women with postmenopausal bleeding. The study aims to answer the following research questions: * What is the diagnostic accuracy of DNA methylation testing in urine, vaginal and cervical samples compared to traditional TVUS for endometrial cancer detection? * What is the 2-year risk of EC among women testing negative on TVUS and/or DNA methylation tests or those testing positive on methylation only? Researchers will compare DNA methylation testing in patient-collected urine and vaginal samples as well as in clinician-collected cervical samples, with the traditional diagnostic pathway for women with PMB, which includes TVUS evaluati

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📋 Eligibility rules (as published)
Inclusion Criteria: * Postmenopausal bleeding (defined as vaginal bleeding after absence of periods for ≥ 12 months) undergoing diagnostic evaluation for EC at gynaecological departments * Treated in Central Denmark Region or Southern Denmark Region, Denmark * Able to provide written consent for participation * Able to read and understand Danish Exclusion Criteria: * Other concurrent cancer diagnosis besides diagnostic evaluation for postmenopausal bleeding * Withdrawal of consent * Hysterectomized
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What it tests

  • DNA-methylation testing in patient-collected urine and vaginal samples and clinician-collected cervical samples
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Where

3 sites
Department of Obstetrics and Gynaecology, Aarhus University Hospital
Aarhus N, Denmark
Department of Obstetrics and Gynaecology, Odense University Hospital
Odense, Denmark
Department of Obstetrics and Gynaecology, Randers Regional Hospital
Randers, Denmark
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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