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

NCT06846775 | Recruiting

• 1 other identifier: EC-methy-PCS-case-control
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Endometrial Cancer

Keywords

DNA-methylation testing; Endometrial Cancer; Patient-collected samples; Urine samples; Vaginal samples

Outcome Measures

Primary Outcomes (1)

• Area Under the Curve

  The diagnostic potential of the six markers for distinguishing patients and controls for EC detection will be illustrated by ROC curves and results will be quantified by AUC with 95% CIs.

  From enrollment and to the end of follow-up at 2 years.

Study Arms (2)

Women with endometrial cancer

Women with diagnosed endometrial cancer ≥ 60 years, without any other concurrent cancer diagnoses. All participants will be asked to collect a urine and vaginal sample, fill out a life style questionnaire and a questionnaire about user experience and preferences.

Diagnostic Test: DNA-methylation testing in patient-collected urine and vaginal samples

Healthy controls

Gynaecologically and oncolocigally healthy controls ≥ 60 years. All participants will be asked to collect a urine and vaginal sample, fill out a life style questionnaire and a questionnaire about user experience and preferences.

Diagnostic Test: DNA-methylation testing in patient-collected urine and vaginal samples

Interventions

DNA-methylation testing in patient-collected urine and vaginal samples DIAGNOSTIC_TEST

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.

Healthy controls; Women with endometrial cancer

Eligibility Criteria

• Age: 60 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cases will be recruited from Department of Obstetrics and Gynaecology, Aarhus University Hospital, Central Denmark Region, and Odense University Hospital, Southern Denmark Region, Denmark. Controls will recruited from Department of Orthopaedics, Randers Regional Hospital, Central Denmark Region, Denmark.

You may qualify if:

• 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

You may not qualify if:

• Other concurrent cancer diagnosis besides cancer corpus uteri
• Withdrawal of consent
• Postmenopausal women ≥ 60 years
• Living in Central Denmark Region, Denmark
• Able to provide written consent for participation
• Able to read and understand Danish
• 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.

Sponsors & Collaborators

• Central Denmark Region: collaborator
• University of Aarhus: lead
• University of Southern Denmark: collaborator
• Region of Southern Denmark: collaborator
• Amsterdam UMC: collaborator

Study Sites (3)

Department of Obstetrics and Gynaecology, Aarhus University Hospital

Aarhus N, 8200, Denmark

RECRUITING

Department of Obstetrics and Gynaecology, Odense University Hospital

Odense, 5000, Denmark

RECRUITING

Department of Orthopaedics, Randers Regional Hospital

Randers, 8930, Denmark

RECRUITING

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Biospecimen

Retention: SAMPLES WITH DNA

Patient-collected urine and vaginal samples.

MeSH Terms

Conditions

Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Mette Tranberg

  University Research Clinic for Cancer Screening, Department of Public Health Programmes, Randers Regional Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karen O. Binderup

CONTACT

+4578420187; kabind@rm.dk

Mette Tranberg, PhD

CONTACT

+4578420264; mettrani@rm.dk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2025
• First Posted: February 26, 2025
• Study Start: April 15, 2025
• Primary Completion: February 28, 2026
• Study Completion (Estimated): January 30, 2028
• Last Updated: January 26, 2026

Record last verified: 2025-04

Locations

DK (3)