Condition: Postmenopausal Bleeding · Sponsor: University of Aarhus
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 evaluation, and when indicated by abnormal TVUS findings, endometrial biopsy according to clinical guidelines. Participants will * take a urine and vaginal sample * have a cervical sample collected by a clinician * undergo TVUS evaluation according to clinical guidelines * If TVUS shows thickened endometrium (≥ 5 mm) and/or irregularity, an endometrial biopsy will be collected according to clinical guidelines * fill out a questionnaire regarding acceptability and preferences of sampling methods and complete a lifestyle questionnaire.
This description comes directly from the study's public registry record.
Karen O. Binderup · +4524656562 · kabind@rm.dk
Mette Tranberg, PhD · +4578420264 · mettrani@rm.dk
Always discuss trial participation with your own doctor first.
| 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 Obstetrics and Gynaecology, Randers Regional Hospital | Randers, Denmark | Not Yet Recruiting |
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Source record: clinicaltrials.gov/study/NCT07400835