Expression of MCM5 in Urine in Patients With Urothelial Cancers

• Conditions: Bladder Cancer
• Interventions: Diagnostic Test: Assessment of expression of MCM5 in the urine (ADX Bladder)

• Registration Number: NCT03796299
• Lead Sponsor: Medical University of Warsaw

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-12
• Study First Submitted: 2018-12-27
• Study Start: 2019-01
• Study First Submitted QC: 2019-01-03
• Last Update Submitted: 2019-01-03
• Study First Posted: 2019-01-08
• Last Update Posted: 2019-01-08
• Primary Completion: 2019-08
• Study Completion: 2019-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 180

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	Assessment of expression of MCM5 in the urine (ADX Bladder)	Patients with bladder cancer
3 (control)	Assessment of expression of MCM5 in the urine (ADX Bladder)	Controls
2	Assessment of expression of MCM5 in the urine (ADX Bladder)	Patients with upper urinary tract cancer

Primary Outcome Measures

Name	Time	Method
Expression of MCM-5 in the urine	Within 48 hours after subject enrollment	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).

Trial Locations

Locations (1)

Medical University of Warsaw, Dept. of Urology; 🇵🇱 Warsaw, Poland