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OpenTrials
Completed

NCT Number: NCT04317261

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

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with gross or persistent microscopic hematuria with irritative bladder symptoms

Exclusion criteria

  • patients on anticoagulants
  • patients with history of radiotherapy

Treatment and study plan

Xpert Bladder Cancer Monitor (Xpert Monitor) test and assay of urinary metabolomics (gene expression of CRAT and SLC)

Diagnostic Test

Urine sample is evaluated for RNA and urinary metabolites

Primary outcomes

  1. Diagnostic performance of Xpert Bladder Cancer Monitor (Xpert Monitor) test

    Time frame: 1 year

    Diagnostic performance of Xpert Bladder Cancer Monitor (Xpert Monitor) test for bladder cancer detection in patients with hematuria

  2. Diagnostic performance of assay of urinary metabolomics (gene expression of CRAT and SLC)

    Time frame: 1 year

    Diagnostic performance of assay of urinary metabolomics (gene expression of CRAT and SLC) for bladder cancer detection in patients with hematuria

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Mar 23, 2020
Registry last updated
Mar 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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