HematuriaDRIVENCT04943380
Efficacy and Utility of Cxbladder Tests in Hematuria Patients
An observational study of Hematuria and Urothelial Carcinoma, run by Pacific Edge Limited at 10 sites in United States.
Trial summary
Prospective observational study to validate the performance characteristics and clinical utility of Cxbladder tests in a Veterans Affairs cohort. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematuria, Urothelial Carcinoma
- What is being tested?
- Cxbladder
- How many people
- 682 participants
- Where
- 10 sitesUnited States
- Study dates
- 8 Nov 2019to 18 Jan 2024
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: This study will be conducted with all hematuria patients who present to an outpatient clinic to undergo clinical assessment including cystoscopy and who fulfil study requirements. Consented eligible patients will attend their scheduled clinic visit and undergo all standard tests as clinically indicated.
Who may be able to join
- Patient is undergoing investigation of recent confirmed hematuria (by either flexible or rigid cystoscopy/TURBT), including hematuria patients referred due to suspicious/positive imaging, in order to determine the presence of urothelial carcinoma.
- Able to provide a voided urine sample of the required minimum volume
- Able to give written consent
- Able and willing to comply with study requirements
- Aged 18 years or older
Who cannot join
- Prior history of bladder malignancy, prostate or renal cell carcinoma
- Prior genitourinary manipulation (flexible or rigid cystoscopy / catheterisation, urethral dilation) in the 14 days before urine collection
- Previous alkylating based chemotherapy
- Known Pregnancy.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Bay Pines Veterans Affairs
Bay Pines, Florida, 33744-8200
Medical University of South Carolina
Charleston, South Carolina, 29401
South Florida Veterans Affairs
Miami, Florida, 33125
Minneapolis VA Health Care System
Minneapolis, Minnesota, 55417
James J. Peters VAMC
New York, New York, 10468-3904
Oklahoma City VA Hospital
Oklahoma City, Oklahoma, 73104
NWIHCS-Omaha VA Medical Center
Omaha, Nebraska, 68105
Veterans Medical Research Foundation
San Diego, California, 92161
James A Haley Veterans' Hospital
Tampa, Florida, 33612-4745
White River Junction VAMC
White River Junction, Vermont, 05009
About this study
Official title: An Observational Study of Efficacy and Utility of Cxbladder Tests in the Identification of Low vs High Risk Patients and the Detection of Urothelial Carcinoma in Patients Presenting With Hematuria
Prospective observational study to validate the performance characteristics and clinical utility of Cxbladder tests in a Veterans Affairs cohort.
Read the detailed description
Non-invasive, voided urine sample used for both Cxbladder molecular tests, voided urine sample may be used for standard of care testing. Retrospective analysis of data after study completion ensures a de-phasing of study sample analysis from clinical decision making; patient treatment and management.
The study aims to sequentially recruit up to 1000 patients presenting for assessment of hematuria (microscopic or macroscopic) by cystoscopy across multiple Veterans Affairs sites
- Conditions
- Hematuria, Urothelial Carcinoma
- Being tested
- Cxbladder
- Medical subject headings
- Hematuria, Carcinoma, Transitional Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CxbladderDiagnostic test
The Cxbladder Detect+ test is a molecular diagnostic test. The test consists of six DNA biomarkers and five RNA biomarkers measured in a small volume of urine. is an enhanced version of the Cxbladder Detect test.
| Study group | Role | What they receive |
|---|---|---|
| patients with hematuria undergoing investigation for UC | Patients will be recruited from those presenting with hematuria and undergoing investigative cystoscopy for the determination of possible urothelial carcinoma. This includes patients referred via imaging or from other departments for assessment of hematuria. Microscopic hematuria is defined as ≥ 3 red blood cells per high-powered microscopy field for a properly collected urine sample. Receives: Diagnostic Test: Cxbladder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with bladder cancer who are correctly identified as having cancer (true positives) and no cancer (true negatives) by the Cxbladder test.
The Cxbladder test results will be compared to that of cystoscopy, which is the gold standard method for diagnosing urothelial cancer; the true positive and true negative rates will be measured, along with the false positive and false negative rates of the test. The results will be reported as sensitivity and specificity of the Cxbladder test for detecting urothelial cancer in patients with hematuria
Measured: From enrolment to when a UC diagnosis is made or patient is considered UC negative (maximum period 6-months)
Probability that patients identified as having cancer and no cancer by the Cxbladder test truly have cancer (positive predictive value; PPV), and truly have no cancer (negative predictive value; NPV) respectively.
The Cxbladder test results will be compared to that of cystoscopy, which is the gold standard method for diagnosing urothelial cancer; the true positive and true negative rates will be measured, along with the false positive and false negative rates of the test. The results will be reported as sensitivity and specificity of the Cxbladder test for detecting urothelial cancer in patients with recurrent disease.
Measured: From enrolment to when a UC diagnosis is made or patient is considered UC negative (maximum period 6-months).
Secondary outcomes (5)
To identify whether patients received a UC diagnosis 6- and 24-months post urine sample collection
To identify by records review within six months and up to 24-months after the initial urine sample collection whether the patient received a diagnosis of UC of the bladder and/or upper tract.
Measured: The outcome measure will be assessed by 6- and up to 24-months after trial completion.
Validation of performance characteristics of Cxbladder tests through sub-group analyses
To validate the performance characteristics (sensitivity, specificity, negative predictive value, positive predictive value) and true negative rate of Cxbladder tests through sub-group analysis (gross hematuria; microhematuria; inflammation), in a VA cohort, for patients with a recent history of hematuria who are undergoing investigative cystoscopy.
Measured: From enrolment to when a UC diagnosis is made or patient is considered UC negative (maximum period 6-months).
Comparison of the Cxbladder test's sensitivity, specificity, PPV and NPV with that of Cytology.
Performance characteristics (sensitivity, specificity, PPV and NPV) of the Cxbladder test for detecting recurring urothelial cancer will be compared to urine cytology, in addition to the gold standard test (cystoscopy). All comparator tests will be carried out on the same voided urine sample used for Cxbladder tests.
Measured: From enrolment to when a UC diagnosis is made or patient is considered UC negative (maximum period 6-months).
To compare the theoretical clinical outcome of patients tested using Cxbladder signatures before investigative cystoscopy with evaluation by cystoscopy alone to establish the true proportion requiring cystoscopy.
To compare the theoretical clinical outcome of patients tested using Cxbladder signatures before investigative cystoscopy with evaluation by (positive, negative or suspicious) cystoscopy alone to establish the true proportion requiring cystoscopy, thereby determining the potential of Cxbladder to reduce or adjudicate the cystoscopy burden of hematuria patients and/or sub cohorts under clinical evaluation in a hospital urology clinic setting.
Measured: From enrolment to when a UC diagnosis is made or patient is considered UC negative (maximum period 6-months).
Performance characteristics of Cxbladder Triage and Cxbladder Detect compared with results generated at other clinical sites
To evaluate the performance characteristics of Cxbladder Triage and Cxbladder Detect compared with results generated at other clinical sites, and to the results of the pulished clinical studies by O'Sullivan et al in 2012 and Kavalieris et al in 2015
Measured: The outcome measure will be assessed from enrolment to when a UC diagnosis is made or patient is considered UC negative for this trial (maximum period 24-months) and completed following completion of other similar trials.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2021
- Study start8 Nov 2019
- Primary completion18 Jan 2024
- Study completion18 Jan 2024
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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 682 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pacific Edge Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tony Lough, PhD, Study chair, Pacific Edge Pty Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04943380
- Sponsor's protocol ID
- CXB/2019/VA
- Acronym
- DRIVE
- Status last verified
- Apr 2026
- First submitted
- 2 Mar 2020
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study of Efficacy and Utility of Cxbladder Tests in the Identification of Low vs High Risk Patients and the Detection of Urothelial Carcinoma in Patients Presenting With Hematuria
- ClinicalTrials.gov ID
- NCT04943380
- Acronym / sponsor ID
- DRIVE / CXB/2019/VA
- Conditions
- Hematuria, Urothelial Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 682 participants (actual)
- Lead sponsor
- Pacific Edge LimitedIndustry (pharma, biotech, devices)
- Study start
- 8 Nov 2019 (actual)
- Primary completion
- 18 Jan 2024 (actual)
- Study completion
- 18 Jan 2024 (actual)
- First posted
- 29 Jun 2021 (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.
Prospective observational study to validate the performance characteristics and clinical utility of Cxbladder tests in a Veterans Affairs cohort.
Detailed description
Non-invasive, voided urine sample used for both Cxbladder molecular tests, voided urine sample may be used for standard of care testing. Retrospective analysis of data after study completion ensures a de-phasing of study sample analysis from clinical decision making; patient treatment and management.
The study aims to sequentially recruit up to 1000 patients presenting for assessment of hematuria (microscopic or macroscopic) by cystoscopy across multiple Veterans Affairs sites
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with hematuria undergoing investigation for UC | – | Diagnostic Test: CxbladderPatients will be recruited from those presenting with hematuria and undergoing investigative cystoscopy for the determination of possible urothelial carcinoma. This includes patients referred via imaging or from other departments for assessment of hematuria. Microscopic hematuria is defined as ≥ 3 red blood cells per high-powered microscopy field for a properly collected urine sample. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will be conducted with all hematuria patients who present to an outpatient clinic to undergo clinical assessment including cystoscopy and who fulfil study requirements. Consented eligible patients will attend their scheduled clinic visit and undergo all standard tests as clinically indicated.
Key inclusion criteria (5 listed)
- Patient is undergoing investigation of recent confirmed hematuria (by either flexible or rigid cystoscopy/TURBT), including hematuria patients referred due to suspicious/positive imaging, in order to determine the presence of urothelial carcinoma.
- Able to provide a voided urine sample of the required minimum volume
- Able to give written consent
- Able and willing to comply with study requirements
- Aged 18 years or older
Key exclusion criteria (4 listed)
- Prior history of bladder malignancy, prostate or renal cell carcinoma
- Prior genitourinary manipulation (flexible or rigid cystoscopy / catheterisation, urethral dilation) in the 14 days before urine collection
- Previous alkylating based chemotherapy
- Known Pregnancy.
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 |
|---|---|---|
| CxbladderThe Cxbladder Detect+ test is a molecular diagnostic test. The test consists of six DNA biomarkers and five RNA biomarkers measured in a small volume of urine. is an enhanced version of the Cxbladder Detect test. | Diagnostic test | patients with hematuria undergoing investigation for UC |
Primary outcome
Proportion of participants with bladder cancer who are correctly identified as having cancer (true positives) and no cancer (true negatives) by the Cxbladder test.
Time frame: From enrolment to when a UC diagnosis is made or patient is considered UC negative (maximum period 6-months)
The Cxbladder test results will be compared to that of cystoscopy, which is the gold standard method for diagnosing urothelial cancer; the true positive and true negative rates will be measured, along with the false positive and false negative rates of the test. The results will be reported as sensitivity and specificity of the Cxbladder test for detecting urothelial cancer in patients with hematuria
Probability that patients identified as having cancer and no cancer by the Cxbladder test truly have cancer (positive predictive value; PPV), and truly have no cancer (negative predictive value; NPV) respectively.
Time frame: From enrolment to when a UC diagnosis is made or patient is considered UC negative (maximum period 6-months).
The Cxbladder test results will be compared to that of cystoscopy, which is the gold standard method for diagnosing urothelial cancer; the true positive and true negative rates will be measured, along with the false positive and false negative rates of the test. The results will be reported as sensitivity and specificity of the Cxbladder test for detecting urothelial cancer in patients with recurrent disease.
5 secondary outcomes
To identify whether patients received a UC diagnosis 6- and 24-months post urine sample collection
Time frame: The outcome measure will be assessed by 6- and up to 24-months after trial completion.
Validation of performance characteristics of Cxbladder tests through sub-group analyses
Time frame: From enrolment to when a UC diagnosis is made or patient is considered UC negative (maximum period 6-months).
Comparison of the Cxbladder test's sensitivity, specificity, PPV and NPV with that of Cytology.
Time frame: From enrolment to when a UC diagnosis is made or patient is considered UC negative (maximum period 6-months).
To compare the theoretical clinical outcome of patients tested using Cxbladder signatures before investigative cystoscopy with evaluation by cystoscopy alone to establish the true proportion requiring cystoscopy.
Time frame: From enrolment to when a UC diagnosis is made or patient is considered UC negative (maximum period 6-months).
Performance characteristics of Cxbladder Triage and Cxbladder Detect compared with results generated at other clinical sites
Time frame: The outcome measure will be assessed from enrolment to when a UC diagnosis is made or patient is considered UC negative for this trial (maximum period 24-months) and completed following completion of other similar trials.
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 24 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Hematuria
Active, not recruitingObservational study
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
BPH (Benign Prostatic Hyperplasia), BPH With Symptomatic Lower Urinary Tract Symptoms
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.
Tony Lough, PhD study chair
Pacific Edge Pty Ltd
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hematuria and Urothelial Carcinoma, run by Pacific Edge Limited at 10 sites in United States.
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 5 inclusion and 4 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 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. 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?
Proportion of participants with bladder cancer who are correctly identified as having cancer (true positives) and no cancer (true negatives) by the Cxbladder test. (time frame: From enrolment to when a UC diagnosis is made or patient is considered UC negative (maximum period 6-months)). 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 24 Apr 2026.