MedTrace Logo

Evaluation of MCM5 in Postmenopausal Bleeding Patients

NCT05287048 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 2000

Last updated 2023-02-01

No results posted yet for this study

Summary

The objective of this multi-centre, prospective study, is to evaluate the performance of a urine MCM5 ELISA test (ADXGYNAE) in the detection of endometrial cancer in patients with postmenopausal bleeding. Patients attending a gynaecology clinic for investigation of postmenopausal bleeding will be recruited and asked to provide a urine sample to be tested. The results of the MCM5 test will be recorded and compared to the patient's routine investigations to determine the clinical utility of the test as an aid in the diagnosis of endometrial cancer.

Conditions

Interventions

DIAGNOSTIC_TEST

MCM5 ELISA

ADXGYNAE is a non-invasive ELISA utilising a combination of two monoclonal antibodies for the detection of MCM5 in urine sediment. It is intended to aid in the detection of endometrial cancer in women with postmenopausal bleeding who are suspected of having endometrial cancer. Participants will be asked to provide a urine specimen, which will be centrifuged before the sediment is lysed. The lysed sample will then be tested with the MCM5 ELISA.

Sponsors & Collaborators

  • Arquer Diagnostics Ltd

    lead INDUSTRY

Principal Investigators

  • Professor Richard Edmondson, MD · Central Manchester NHS Foundation Trust

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-01
Primary Completion
2023-09-30
Completion
2023-09-30

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05287048 on ClinicalTrials.gov