HematuriaNCT04317261
Role of Novel Urinary Genomic and Metablomic Markers in Diagnosis of Bladder Cancer in Patients With Hematuria
A study testing Xpert Bladder Cancer Monitor (Xpert Monitor) test and assay of urinary metabolomics (gene expression of CRAT and SLC) in people with Hematuria and Bladder Cancer, run by Mansoura University at 1 site in Egypt.
Trial summary
Our goal is to develop a noninvasive, fast and simple assay to detect BCa on the GeneXpert system and metablomic genes. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hematuria, Bladder Cancer
- What is being tested?
- Xpert Bladder Cancer Monitor (Xpert Monitor) test and assay of urinary metabolomics (gene expression of CRAT and SLC)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 181 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2018to 1 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with gross or persistent microscopic hematuria with irritative bladder symptoms
Who cannot join
- patients on anticoagulants
- patients with history of radiotherapy
Trial locations and contacts
1 site in 1 country.
About this study
Our goal is to develop a noninvasive, fast and simple assay to detect BCa on the GeneXpert system and metablomic genes.
Read the 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.
- Conditions
- Hematuria, Bladder Cancer
- Being tested
- Xpert Bladder Cancer Monitor (Xpert Monitor) test and assay of urinary metabolomics (gene expression of CRAT and SLC)
- Keywords
- Hematuria, Bladder cancer, Biomarkers, mRNA, Cytology, metabolomics
- Medical subject headings
- Hematuria, Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Hematuria patients | Experimental | Not described Receives: Diagnostic Test: Xpert Bladder Cancer Monitor (Xpert Monitor) test and assay of urinary metabolomics (gene expression of CRAT and SLC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2020
- Study start1 Mar 2018
- Primary completion1 Mar 2020
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HematuriaStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 181 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Abdel-Lateif El-Sawy, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04317261
- Sponsor's protocol ID
- AE 4320
- Status last verified
- Mar 2020
- First submitted
- 4 Mar 2020
- Last updated
- 23 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Novel Urinary Genomic and Metablomic Markers in Diagnosis of Bladder Cancer in Patients With Hematuria
- ClinicalTrials.gov ID
- NCT04317261
- Acronym / sponsor ID
- AE 4320
- Conditions
- Hematuria, Bladder Cancer
- Keywords
- Hematuria, Bladder cancer, Biomarkers, mRNA, Cytology, metabolomics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 181 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 23 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hematuria patients | Experimental | Diagnostic Test: Xpert Bladder Cancer Monitor (Xpert Monitor) test and assay of urinary metabolomics (gene expression of CRAT and SLC) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with gross or persistent microscopic hematuria with irritative bladder symptoms
Key exclusion criteria (2 listed)
- patients on anticoagulants
- patients with history of radiotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Diagnostic test | Hematuria patients |
Primary outcome
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Hematuria
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Detection and Risk Stratification in Veterans Presenting With Microscopic Hematuria
Urothelial Carcinoma
RecruitingObservational study
Screening for Urological Malignancies Using a Urine Exfoliated Cell Fluorescence Assay in a Hematuria Population
UTUC, UC (Urothelial Cancer)
Not yet recruitingPhase 3
Effectiveness of Medical and Environmental Interventions to Reduce Cystoscopy Discomfort (CystoDiscomfort)
Bladder (Urothelial, Transitional Cell) Cancer, Hematuria
Recruiting
Use of PuraStat Following Aquablation to Determine if There is Change in Hematuria & Probability of Same Day Discharge
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Recruiting
Study to Assess the Impact of the Urine Test Cxbladder Triage Plus on the Number of Cystoscopies Performed on Patients With Invisible Blood in Their Urine.
Hematuria - Cause Not Known
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Xpert Bladder Cancer Monitor (Xpert Monitor) test and assay of urinary metabolomics (gene expression of CRAT and SLC) in people with Hematuria and Bladder Cancer, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic performance of Xpert Bladder Cancer Monitor (Xpert Monitor) test (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2020.