Methylated Biomarkers Predictive of Endometrial Cancer Risk (BioMEC)

January 23, 2025 updated by: Sarah Kitson, University of Manchester
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Manchester, United Kingdom, M13 9WL
        • Manchester University NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cases
Women diagnosed with endometrial cancer of any grade, stage and histological type
Procedure: Hysterectomy
Elective hysterectomy
Controls
Women undergoing a hysterectomy for benign indications
Procedure: Hysterectomy
Elective hysterectomy

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Manchester

Collaborators

Queen Mary University of London

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 31, 2024

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

July 31, 2024

First Submitted That Met QC Criteria

January 23, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 23, 2025

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 334940

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Researchers to write to CI requesting IPD. Fully anonymised data may be shared with other researchers upon receipt of approval from relevant ethics committee

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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