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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
AgeNot listed
SponsorUniversity of Aarhus

About this trial

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 criteria

Qualifiers

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

Disqualifiers

Other concurrent cancer diagnosis besides diagnostic evaluation for postmenopausal bleeding

Withdrawal of consent

Hysterectomized

Trial design

Treatments tested in this trial

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

Treatment groups

600 Participants
are divided into 1 treatment group

Sponsors and collaborators

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