Evaluation of MCM5 in Postmenopausal Bleeding Patients

Recruiting

• Conditions: Endometrial Cancer

• Registration Number: NCT05287048
• Lead Sponsor: Arquer Diagnostics Ltd

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-01
• Study First Submitted: 2022-03-02
• Study First Submitted QC: 2022-03-10
• Study First Posted: 2022-03-18
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-30
• Last Update Posted: 2023-02-01
• Primary Completion: 2023-09
• Study Completion: 2023-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 2000

Inclusion Criteria

• Patients 18 years of age or older
• Patients who are at least 1 year post-menopausal i.e. have not had a menstrual period for at least one year
• Patients who, in the opinion of the Investigator, are suitable for standard gynaecological investigations as part of normal clinical practice
• Patients who are, in the opinion of the Investigator, able to understand the purpose of the study and provide a full void urine specimen
• Patients who are able to give voluntary, written informed consent to participate in this study and from whom consent has been obtained

Exclusion Criteria

• Patients with known symptomatic calculi within the urino-genitary system
• Patients currently undergoing chemotherapy or radiotherapy
• Patients who have previously been diagnosed with bladder or renal cancer who are currently in follow up
• Patients with a medical contraindication to endometrial biopsy
• Patients who do not wish to have an endometrial biopsy even if deemed necessary by the treating physician
• Patients who have had urological instrumentation to the urinary tract within 14 days prior to the test (including catheterisation)
• Patients who have had any gynaecological instrumentation in the previous 14 days

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensitivity, specificity and negative predictive value (NPV) of ADXGYNAE will be calculated to establish the diagnostic accuracy for the detection of endometrial cancer.	1 year	The MCM5 test result will be compared with data obtained from patient's standard of care clinical investigations, including results from transvaginal ultrasound (TVUS) and endometrial biopsy or hysteroscopy. A definitive diagnosis of endometrial cancer will be confirmed by the presence of histologically proven endometrial cancer on resection/biopsy. Patients who do not have an endometrial biopsy will be followed up at 6 months to identify if further investigations were carried out.

Trial Locations

Locations (1)

Saint Mary's Hospital, Central Manchester NHS Foundation Trust; 🇬🇧 Manchester, United Kingdom