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.
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
Other concurrent cancer diagnosis besides diagnostic evaluation for postmenopausal bleeding
Withdrawal of consent
Hysterectomized
Women with postmenopausal bleeding undergoing diagnostic evaluation for endometrial cancer will be recruited from Department of Obstetrics and Gynaecology, Aarhus University Hospital, Randers Regional Hospital, Central Denmark Region, and Odense University Hospital, Southern Denmark Region, Denmark.
Other
Cross-sectional
DNA-methylation testing in patient-collected urine and vaginal samples and clinician-collected cervical samples
Diagnostic testDNA-methylation testing of methylation markers CDO1, GHSR and ZIC1 for patient-collected vaginal samples, GHSR, CDH13 and SST for patient-collected urine samples and CDH13 + CDO1 + ZIC1 for clinician-collected cervical samples.
Area under the Curve (AUC)
The performance of each methylation marker panels in urine, vaginal and cervical samples and the TVUS will be evaluated by area Under the Curve with 95% CIs.
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University of Aarhus
Lead sponsor
Central Denmark Region
Collaborator
University of Southern Denmark
Collaborator
Randers Regional Hospital
Collaborator
Region of Southern Denmark
Collaborator
Amsterdam UMC
Collaborator
Aarhus University Hospital
Collaborator
