Expression of MCM5 in Urine in Patients With Urothelial Cancers

Study Overview
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Brief Summary
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In patients with non-muscle-invasive bladder cancer, the development and introduction to the clinical practice of an adequately accurate biomarker may allow to limit the indications for performing control cystoscopy. Thus, it will reduce the discomfort and stress of patients, the risk of complications of the invasive procedure and probably significantly reduce the costs incurred by healthcare systems. The aim of the present study is to determine the usefulness of the determination of MCM5 protein expression in the urine of patients with urinary bladder or upper urinary tract cancer.

Official Title
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Expression of MCM5 in Urine in Patients With Urothelial Cancers

Conditions
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Bladder Cancer

Intervention / Treatment
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* Diagnostic Test: Assessment of expression of MCM5 in the urine (ADX Bladder)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age >18 years, written consent to participate in the study, ability to void and collect >50ml of urine, recurrent bladder cancer confirmed by cystoscopy (group 1) or upper urinary tract tumor confirmed by imaging studies (group 2) or no history of urological/gynecological cancers (controls) Exclusion Criteria: urinary tracy infection, nephrolithiasis

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Patients with bladder cancer | Diagnostic Test: Assessment of expression of MCM5 in the urine (ADX Bladder)<br>* Each participant will be asked to urinate in a plastic container. Urine will be centrifuged afterwards, then the expression of MCM5 protein will be examined in cells from urine sediment. For this purpose, it is planned to use the Arquer Diagnostics ADXBLADDER test. It is an enzyme linked immunosorbent assay (ELISA) using two monoclonal antibodies directed against two different epitopes. Both antibodies have high affinity and specificity for the MCM5 antigen.<br>|
| 2<br>Patients with upper urinary tract cancer | Diagnostic Test: Assessment of expression of MCM5 in the urine (ADX Bladder)<br>* Each participant will be asked to urinate in a plastic container. Urine will be centrifuged afterwards, then the expression of MCM5 protein will be examined in cells from urine sediment. For this purpose, it is planned to use the Arquer Diagnostics ADXBLADDER test. It is an enzyme linked immunosorbent assay (ELISA) using two monoclonal antibodies directed against two different epitopes. Both antibodies have high affinity and specificity for the MCM5 antigen.<br>|
| 3 (control)<br>Controls | Diagnostic Test: Assessment of expression of MCM5 in the urine (ADX Bladder)<br>* Each participant will be asked to urinate in a plastic container. Urine will be centrifuged afterwards, then the expression of MCM5 protein will be examined in cells from urine sediment. For this purpose, it is planned to use the Arquer Diagnostics ADXBLADDER test. It is an enzyme linked immunosorbent assay (ELISA) using two monoclonal antibodies directed against two different epitopes. Both antibodies have high affinity and specificity for the MCM5 antigen.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Expression of MCM-5 in the urine | Expression of MCM-5 will be determined in urine sediment by Arquer Diagnostics ADXBLADDER test (ELISA test using two monoclonal antibodies directed against epitopes of high affinity and specificity for the MCM5 antigen). | Within 48 hours after subject enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bladder cancer, biomarker, urothelial cancer, cystoscopy