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

Bladder Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04317261
• Other study ID #: AE 4320
• Status: Completed
• Phase: N/A
• Start date: March 1, 2018
• Est. completion date: March 1, 2020

Study information

• Verified date: March 2020
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 181
• Est. completion date: March 1, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• patients on anticoagulants

• patients with history of radiotherapy

Related Conditions & MeSH terms

• Bladder Cancer
• Hematuria
• Urinary Bladder Neoplasms

Intervention

Diagnostic Test:
• Xpert Bladder Cancer Monitor (Xpert Monitor) test and assay of urinary metabolomics (gene expression of CRAT and SLC)
Urine sample is evaluated for RNA and urinary metabolites

Locations

Country	Name	City	State
Egypt	Mansoura University	Mansoura	DK

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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