Evaluation of MCM5 in Postmenopausal Bleeding Patients

Study Overview
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Brief Summary
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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.

Official Title
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A Performance Evaluation Study of Arquer Diagnostics Ltd's MCM5 ELISA (ADXGYNAE) Test to Aid in the Diagnosis of Endometrial Cancer

Conditions
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Endometrial Cancer

Intervention / Treatment
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* Diagnostic Test: MCM5 ELISA


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with postmenopausal bleeding<br>Patients attending a gynaecology clinic for investigation of postmenopausal bleeding and undergoing a transvaginal ultrasound (TVUS). | Diagnostic Test: MCM5 ELISA<br>* 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.<br>* Other names: ADXGYNAE;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity, specificity and negative predictive value (NPV) of ADXGYNAE will be calculated to establish the diagnostic accuracy for the detection of endometrial cancer. | 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. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endometrial cancer, Postmenopausal bleeding, MCM5, Biomarker