Study of DNA Methylation Testing for Detecting Endometrial Cancer Risk in Women with Postmenopausal Bleeding Using Urine, Vaginal, and Cervical Samples

What this Trial Is About

Researchers are investigating the usefulness of DNA methylation testing in urine, vaginal, and cervical samples to assess the risk of endometrial cancer in women experiencing postmenopausal bleeding. This observational study aims to compare the accuracy of DNA methylation testing with the traditional transvaginal ultrasound TVUS method and to evaluate the two-year risk of endometrial cancer among women with different test results. The study addresses the need for a simpler, non-invasive test to improve diagnosis and reduce unnecessary procedures. Participants will provide urine and vaginal samples themselves and have a cervical sample collected by a clinician. They will also undergo a TVUS evaluation according to clinical guidelines. If the ultrasound shows a thickened endometrium or irregularity, an endometrial biopsy will be performed as part of standard care. Samples will be tested for specific DNA methylation markers to detect cancer risk, and results will be compared to the traditional diagnostic pathway. During the study, participants will complete questionnaires about their preferences and acceptability of the sampling methods and provide lifestyle information. Researchers will monitor diagnostic accuracy using the area under the curve AUC at enrollment and diagnosis. Data from biopsies and ultrasounds will be collected from national health databases. The study will also track the safety and effectiveness of the DNA methylation tests over two years, aiming to improve patient care and reduce anxiety and healthcare costs.

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