Methylated Biomarkers Predictive of Endometrial Cancer Risk

Active, not recruiting

• Conditions: Endometrial Cancer

• Registration Number: NCT06800677
• Lead Sponsor: University of Manchester

Brief Summary

The goal of this observational study is to identify endometrial cancer risk predictive biomarkers and to optimise the methodology for their detection and quantification in non-invasive samples.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-07
• Study Start: 2024-07-31
• Study First Submitted: 2024-07-31
• Study First Submitted QC: 2025-01-23
• Last Update Submitted: 2025-01-23
• Study First Posted: 2025-01-30
• Last Update Posted: 2025-01-30
• Primary Completion: 2026-06
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

1. Women aged 45-70 years
2. Attending St Mary's Hospital, Manchester for an elective hysterectomy by any route for either the treatment of endometrial cancer or a benign gynaecological condition
3. Able to consent to participation in the study

Exclusion Criteria

1. Presence of malignancy asides from endometrial cancer
2. Undergoing elective hysterectomy for suspected ovarian cancer

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensitivity, specificity, negative and positive predictive value of single gene methylation classifiers in predicting the presence of endometrial cancer in minimally- and invasive samples	1 day

Secondary Outcome Measures

Name	Time	Method
Sensitivity, specificity, positive and negative predictive value of a multi-gene methylation classifier for predicting the presence of endometrial cancer	1 day

Trial Locations

Locations (1)

Manchester University NHS Foundation Trust; 🇬🇧 Manchester, United Kingdom