Role of Novel Urinary Genomic and Metablomic Markers in Diagnosis of Bladder Cancer in Patients With Hematuria

Study Overview
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Brief Summary
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Our goal is to develop a noninvasive, fast and simple assay to detect BCa on the GeneXpert system and metablomic genes.

Detailed Description
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The Xpert BCa monitor is a novel mRNA-based urine test that measures five mRNA targets (ABL1, ANXA10, UPK1B, CRH, and IGF2) in urine sample by real time RT-PCR. Previous studies had investigated the feasibility and diagnostic performance characteristics of Xpert monitor for surveillance of NMIBC patients (12, 13). It demonstrated a high SN and NPV in relation to urine cytology. On the other hand, metabolic dysfunction has been implicated in a wide variety of human diseases including BC (14). Growth and division of tumor cells are associated with an increase in the activity of a variety of metabolic pathways. Significant alterations in the carnitine-acylcarnitine metabolic pathways were detected in urine speci¬mens from BC patients compared to those of healthy controls (15). The expression of six genes involved in the carnitine-acylcarni¬tine metabolic pathway (CPT1A, CPT1B, CPT1C, CPT2, SLC25A20, and CRAT) was assessed by Won and colleagues. CRAT and SLC25A20 were found to be significantly down regulated in BC patients (16). In this context, we aimed in the current study at prospective assessment of diagnostic performance characteristics of Xpert Bladder Cancer Monitor (Xpert Monitor) test and urinary metabolomics (urinary metabolites of tissue mRNA genes expression CRAT and SLC 25A20) for bladder cancer detection in patients with hematuria.

Official Title
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Role of Novel Urinary Genomic and Metablomic Markers in Diagnosis of Bladder Cancer in Patients With Hematuria

Conditions
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Hematuria, Bladder Cancer

Intervention / Treatment
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* Diagnostic Test: Xpert Bladder Cancer Monitor (Xpert Monitor) test and assay of urinary metabolomics (gene expression of CRAT and SLC)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with gross or persistent microscopic hematuria with irritative bladder symptoms Exclusion Criteria: patients on anticoagulants patients with history of radiotherapy

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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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hematuria patients<br> | Diagnostic Test: Xpert Bladder Cancer Monitor (Xpert Monitor) test and assay of urinary metabolomics (gene expression of CRAT and SLC)<br>* Urine sample is evaluated for RNA and urinary metabolites<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic performance of Xpert Bladder Cancer Monitor (Xpert Monitor) test | Diagnostic performance of Xpert Bladder Cancer Monitor (Xpert Monitor) test for bladder cancer detection in patients with hematuria | 1 year | 
| Diagnostic performance of assay of urinary metabolomics (gene expression of CRAT and SLC) | Diagnostic performance of assay of urinary metabolomics (gene expression of CRAT and SLC) for bladder cancer detection in patients with hematuria | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hematuria, Bladder cancer, Biomarkers, mRNA, Cytology, metabolomics