RecruitingNCT06846775

The Clinical Utility of DNA Methylation Testing in Patient-collected Urine and Vaginal Samples to Detect Endometrial Cancer: a Case-control Study

A Case-control Study of the Clinical Utility of DNA Methylation Testing in Patient-collected Vaginal and Urine Samples: A Novel, Patient-friendly and Simple Diagnostic Solution to Detect Endometrial Cancer.

Sponsor

University of Aarhus

Enrollment

120 participants

Start Date

Apr 15, 2025

Study Type

OBSERVATIONAL

Conditions

Endometrial Cancer

Summary

The goal of this observational case-control study is to investigate the use of DNA-methylation testing in patient-collected urine and vaginal samples to detect endometrial cancer. The study aims to answer the following questions: * Can DNA methylation testing in vaginal and full-void urine samples distinguish endometrial cancer cases from healthy controls? Researchers will compare patient-collected urine and vaginal samples from patients with diagnosed endometrial cancer (cases) to gynaecologically and oncologically healthy controls (controls). Participants will * take a urine and vaginal sample at the hospital. * answer a questionnaire regarding acceptability and preferences of self-sampling methods. * answer a lifestyle questionnaire.

Eligibility

Sex: FEMALEMin Age: 60 Years

Inclusion Criteria9

Women ≥ 60 years
Diagnosed with cancer corpus uteri
Living in Central Denmark Region or Southern Denmark Region, Denmark
Able to provide written consent for participation
Able to read and understand Danish
Postmenopausal women ≥ 60 years
Living in Central Denmark Region, Denmark
Able to provide written consent for participation
Able to read and understand Danish

Exclusion Criteria7

Other concurrent cancer diagnosis besides cancer corpus uteri
Withdrawal of consent
Diagnosed with cancer or undergoing diagnostic assessment herfore without the last 5 years.
Vaginal bleeding within the last 3 months.
Known gynaecological diseases such as cervical dysplasia or atypical endomatrial hyperplasia within the last 5 years.
Previously hysterectomized
Withdrawal of consent.

Interventions

DIAGNOSTIC_TESTDNA-methylation testing in patient-collected urine and vaginal samples

DNA-methylation testing of methylation markers CDO1, GHSR and ZIC1 for patient-collected vaginal samples and GHSR, CDH13 and SST for patient-collected urine samples.