Methylated Biomarkers Predictive of Endometrial Cancer Risk

NCT06800677 | Active Not Recruiting

• 1 other identifier: 334940
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometrial Cancer

Keywords

risk; prevention; prediction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Sensitivity, specificity, positive and negative predictive value of a multi-gene methylation classifier for predicting the presence of endometrial cancer

  1 day

Study Arms (2)

Cases

Women diagnosed with endometrial cancer of any grade, stage and histological type

Procedure: Hysterectomy

Controls

Women undergoing a hysterectomy for benign indications

Procedure: Hysterectomy

Interventions

Hysterectomy PROCEDURE

Elective hysterectomy

Cases; Controls

Eligibility Criteria

• Age: 45 Years - 70 Years
• Gender Eligibility Details: Presence of uterus
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women undergoing an elective hysterectomy at St Mary's Hospital, Manchester, UK for either endometrial cancer or a benign indication

You may qualify if:

• Women aged 45-70 years
• 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
• Able to consent to participation in the study

You may not qualify if:

• Presence of malignancy asides from endometrial cancer
• Undergoing elective hysterectomy for suspected ovarian cancer

Sponsors & Collaborators

• University of Manchester: lead
• Queen Mary University of London: collaborator

Study Sites (1)

Manchester University NHS Foundation Trust

Manchester, M13 9WL, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood, urine, cervicovaginal swab, endometrial biopsy, FFPE blocks from hysterectomy specimen including endometrial tumour and normal endometrium

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

Hysterectomy

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

Intervention Hierarchy (Ancestors)

Gynecologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Lecturer

Study Record Dates

• First Submitted: July 31, 2024
• First Posted: January 30, 2025
• Study Start: July 31, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 30, 2025

Record last verified: 2024-07

Locations

GB (1)