Back to resultsRole of Novel Urinary Genomic and Metablomic Markers in Diagnosis of Bladder Cancer in Patients With Hematuria
Primary Purpose
Hematuria, Bladder Cancer
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Xpert Bladder Cancer Monitor (Xpert Monitor) test and assay of urinary metabolomics (gene expression of CRAT and SLC)
Sponsored by
About this trial
This is an interventional diagnostic trial for Hematuria focused on measuring Hematuria, Bladder cancer, Biomarkers, mRNA, Cytology, metabolomics
Eligibility Criteria
Inclusion Criteria:
- Patients with gross or persistent microscopic hematuria with irritative bladder symptoms
Exclusion Criteria:
- patients on anticoagulants
- patients with history of radiotherapy
Sites / Locations
- Mansoura University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Hematuria patients
Arm Description
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04317261
Brief Title
Role of Novel Urinary Genomic and Metablomic Markers in Diagnosis of Bladder Cancer in Patients With Hematuria
Official Title
Role of Novel Urinary Genomic and Metablomic Markers in Diagnosis of Bladder Cancer in Patients With Hematuria
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
March 1, 2020 (Actual)
Study Completion Date
March 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Our goal is to develop a noninvasive, fast and simple assay to detect BCa on the GeneXpert system and metablomic genes.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematuria, Bladder Cancer
Keywords
Hematuria, Bladder cancer, Biomarkers, mRNA, Cytology, metabolomics
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
181 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hematuria patients
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
Xpert Bladder Cancer Monitor (Xpert Monitor) test and assay of urinary metabolomics (gene expression of CRAT and SLC)
Intervention Description
Urine sample is evaluated for RNA and urinary metabolites
Primary Outcome Measure Information:
Title
Diagnostic performance of Xpert Bladder Cancer Monitor (Xpert Monitor) test
Description
Diagnostic performance of Xpert Bladder Cancer Monitor (Xpert Monitor) test for bladder cancer detection in patients with hematuria
Time Frame
1 year
Title
Diagnostic performance of assay of urinary metabolomics (gene expression of CRAT and SLC)
Description
Diagnostic performance of assay of urinary metabolomics (gene expression of CRAT and SLC) for bladder cancer detection in patients with hematuria
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients with gross or persistent microscopic hematuria with irritative bladder symptoms
Exclusion Criteria:
patients on anticoagulants
patients with history of radiotherapy
Facility Information:
Facility Name
Mansoura University
City
Mansoura
State/Province
DK
ZIP/Postal Code
35516
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Role of Novel Urinary Genomic and Metablomic Markers in Diagnosis of Bladder Cancer in Patients With Hematuria
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