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

Condition(s) studied

Investigational drug(s) / intervention(s)

DNA-methylation testing in patient-collected urine and vaginal samples and clinician-collected cervical samples: DNA-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.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Area under the Curve (AUC) — At the time of enrollment and to the time of diagnosis
  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.

Trial sites (3)

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