Urothelial CarcinomamicroDRIVENCT05889195
Detection and Risk Stratification in Veterans Presenting With Microscopic Hematuria
An observational study of Urothelial Carcinoma, run by Pacific Edge Limited at 3 sites in United States.
Trial summary
It is currently debated whether the use of invasive standard of care procedures, such as cystoscopy, a procedure which involves inserting a thin camera, called a cystoscope, into the bladder to look for signs of disease, is appropriate for patients with microscopic hematuria (blood in the urine that cannot be seen… Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Urothelial Carcinoma
- What is being tested?
- Cxbladder urine test
- How many people
- 1,000 participants
- Where
- 3 sitesUnited States
- Study dates
- 2 Nov 2023to 30 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This is a multicenter, observational study prospectively enrolling up to 1000 subjects with microscopic hematuria (three or more red blood cells per high powered field in one urinalysis; no visible blood in the urine) and gross hematuria (visible blood in the urine) from US sites. This study will be conducted on subjects with microscopic or gross hematuria referred to urology and scheduled for cystoscopy for the investigation of urothelial carcinoma.
Who may be able to join
- Subjects who are referred to urology and are either scheduled for a cystoscopy or have had a cystoscopic investigation within the last two months for the evaluation of hematuria meeting ONE of the following criteria:
- EITHER: (a) Microscopic hematuria, confirmed by urine microscopy of three or more RBC/HPF (or equivalent). OR: (b) Gross hematuria.
- Physically able to provide a voided urine sample from a bladder that has not been surgically altered.
- Able to give informed, written consent.
- Able and willing to comply with study requirements (complete at-home urine sampling, fill in test request forms (TRFs) / tube labels and ship urine back to the central laboratory using a prepaid courier service).
- Aged 18 years or older.
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- Footnotes:
- For the microscopic hematuria patients, the recruitment priority at each respective site will be: i) Patients who have undergone initial diagnostic cystoscopy and have been scheduled for a later TURBT for suspicious lesion in the bladder. ii) Patients who are considered high risk by the AUA 2020 guidelines.
- For gross hematuria patients, the recruitment priority at each respective site will be: i) Patients who have undergone initial diagnostic cystoscopy and have been scheduled for a later TURBT for suspicious lesion in the bladder
Who cannot join
- Prior history of bladder malignancy.
- Reported Cxbladder results within the last six months.
- Prior history of upper tract urothelial carcinoma (UC) or prostatic urethral UC.
- Reconstructed or diverted bladder (e.g., bladder augmentation, ileal conduit, Indiana pouch).
- Subjects aged 89 years of age or older.
- Subjects with a history of pelvic radiation.
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- Subjects currently receiving systemic chemotherapy or has had systemic chemotherapy within the last six weeks.
- Subjects with renal failure on dialysis.
- History of schistosomiasis.
- Subjects who have had intervention (TURBT, diathermia, etc.,) following a previous cystoscopy.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Durham VA Health Care System
Durham, North Carolina, 27705
Tri Valley Urology Medical Group
Murrieta, California, 92562
The Urology Place
San Antonio, Texas, 78240
About this study
Official title: Validation of Cxbladder Triage-Plus for the Detection of Urothelial Carcinoma in Subjects With Microscopic Hematuria (microDRIVE)
It is currently debated whether the use of invasive standard of care procedures, such as cystoscopy, a procedure which involves inserting a thin camera, called a cystoscope, into the bladder to look for signs of disease, is appropriate for patients with microscopic hematuria (blood in the urine that cannot be seen with the naked eye). This is because the risk of disease (bladder cancer - urothelial carcinoma) is relatively low in this population group, approximately 3%. Invasive procedures such as cystoscopy can cause anxiety and pain, in addition to other potential side effects. This has resulted in low admittance for cystoscopy among patients with hematuria (blood in urine) in urology clinics. Therefore, there is a need for a simpler, non-invasive test that can accurately detect the presence or absence of disease (urothelial carcinoma) in patients with microscopic hematuria. Cxbladder, a non-invasive, urine-based test, has the potential to fill this role.
Read the detailed description
This is a multicenter, observational study prospectively enrolling up to 1000 subjects with microscopic hematuria (three or more red blood cells per high powered field in one urinalysis; no visible blood in the urine) and gross hematuria (visible blood in urine) from US sites. This study will be conducted with subjects with a previous history of microscopic or gross hematuria referred to urology and scheduled for cystoscopy for the investigation of urothelial carcinoma. The study will aim to recruit an equal number of microscopic and gross hematuria patients, controlling the proportion of gross hematuria subjects recruited by targeting an approximate 1:1 ratio of microscopic to gross hematuria patients.
Consented, eligible subjects will undergo all standard of care tests as clinically indicated. In addition, one additional urine sample, using remote (at-home) or at-clinic sampling, will be collected to validate the performance characteristics for the Cxbladder Triage-Plus test. The urine sample collected from each subject will be a voided urine sample within 90 days prior to the scheduled cystoscopy or within 10 weeks post-cystoscopy.
The primary aim of this study is to validate the use of Cxbladder Triage-Plus as an effective diagnostic tool to:
- Enable patients with microscopic hematuria who have a low probability of having disease (urothelial carcinoma) to be ruled out from further investigation. This could avoid expensive, invasive work-up, without compromising detection of disease.
- Allow physicians to identify subjects at higher risk of disease (urothelial carcinoma)
- Replace less sensitive urine-based tests (such as urine cytology or other urine genomic tests currently available)
Cxbladder results will not be reported to the subjects or the physicians. Each subject will be required to fill in the date of sample collection in the test-request form and Cxbladder tubes. The site will fill in case-report forms in a professional manner in accordance with good clinical practice (GCP).
- Conditions
- Urothelial Carcinoma
- Being tested
- Cxbladder urine test
- Keywords
- Urothelial Carcinoma, microscopic hematuria, Cxbladder, Urine test, genomic test
- Medical subject headings
- Carcinoma, Transitional Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cxbladder urine testDiagnostic test
Cxbladder tests uses mRNA and DNA biomarkers in the urine to direct the management of UC from diagnosis to surveillance for disease recurrence.
What is being measured
The primary outcome is the main question the study is designed to answer.
To validate the performance characteristics of Cxbladder Triage Plus in a US cohort which will consist of subjects with a recent history of hematuria and are referred to urology and scheduled for cystoscopy for the evaluation of hematuria.
Cxbladder Triage-Plus performance will be measured using performance characteristics such as sensitivity, specificity, negative predictive value and positive predictive value.
Measured: Baseline, pre-intervention / procedure (cystoscopy): Each subject is scheduled for cystoscopy and provides one urine sample for the Cxbladder test pre-procedure
Secondary outcomes (2)
To validate the performance characteristics and Test Negative Rate of Cxbladder Triage Plus through sub-group analysis (gross hematuria, microscopic hematuria, inflammation) for patients with a recent history of hematuria who are undergoing cystoscopy
Cxbladder Triage test performance will be measured using performance characteristics such as sensitivity, specificity, negative predictive value and positive predictive value.
Measured: Baseline, pre-intervention / procedure (cystoscopy): Each subject is scheduled for cystoscopy and provides one urine sample for the Cxbladder test pre-procedure
To evaluate the performance characteristics of both Cxbladder Triage Plus and Cxbladder Triage in a pooled analysis with combined results generated at other clinical sites, and to the results of other published clinical studies.
Cxbladder Triage test performance will be measured using performance characteristics such as sensitivity, specificity, negative predictive value and positive predictive value.
Measured: Baseline, pre-intervention / procedure (cystoscopy): Each subject is scheduled for cystoscopy and provides one urine sample for the Cxbladder test pre-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2023
- Study start2 Nov 2023
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urothelial CarcinomaStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
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 (Australia) Pty Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05889195
- Sponsor's protocol ID
- CXB/2023/microDRIVE
- Acronym
- microDRIVE
- Status last verified
- Sep 2026
- First submitted
- 22 May 2023
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be published in an anonymized report once the study is completed.
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Cxbladder Triage-Plus for the Detection of Urothelial Carcinoma in Subjects With Microscopic Hematuria (microDRIVE)
- ClinicalTrials.gov ID
- NCT05889195
- Acronym / sponsor ID
- microDRIVE / CXB/2023/microDRIVE
- Conditions
- Urothelial Carcinoma
- Keywords
- Urothelial Carcinoma, microscopic hematuria, Cxbladder, Urine test, genomic test
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Pacific Edge LimitedIndustry (pharma, biotech, devices)
- Study start
- 2 Nov 2023 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 5 Jun 2023 (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.
It is currently debated whether the use of invasive standard of care procedures, such as cystoscopy, a procedure which involves inserting a thin camera, called a cystoscope, into the bladder to look for signs of disease, is appropriate for patients with microscopic hematuria (blood in the urine that cannot be seen with the naked eye). This is because the risk of disease (bladder cancer - urothelial carcinoma) is relatively low in this population group, approximately 3%. Invasive procedures such as cystoscopy can cause anxiety and pain, in addition to other potential side effects. This has resulted in low admittance for cystoscopy among patients with hematuria (blood in urine) in urology clinics. Therefore, there is a need for a simpler, non-invasive test that can accurately detect the presence or absence of disease (urothelial carcinoma) in patients with microscopic hematuria. Cxbladder, a non-invasive, urine-based test, has the potential to fill this role.
Detailed description
This is a multicenter, observational study prospectively enrolling up to 1000 subjects with microscopic hematuria (three or more red blood cells per high powered field in one urinalysis; no visible blood in the urine) and gross hematuria (visible blood in urine) from US sites. This study will be conducted with subjects with a previous history of microscopic or gross hematuria referred to urology and scheduled for cystoscopy for the investigation of urothelial carcinoma. The study will aim to recruit an equal number of microscopic and gross hematuria patients, controlling the proportion of gross hematuria subjects recruited by targeting an approximate 1:1 ratio of microscopic to gross hematuria patients.
Consented, eligible subjects will undergo all standard of care tests as clinically indicated. In addition, one additional urine sample, using remote (at-home) or at-clinic sampling, will be collected to validate the performance characteristics for the Cxbladder Triage-Plus test. The urine sample collected from each subject will be a voided urine sample within 90 days prior to the scheduled cystoscopy or within 10 weeks post-cystoscopy.
The primary aim of this study is to validate the use of Cxbladder Triage-Plus as an effective diagnostic tool to:
- Enable patients with microscopic hematuria who have a low probability of having disease (urothelial carcinoma) to be ruled out from further investigation. This could avoid expensive, invasive work-up, without compromising detection of disease.
- Allow physicians to identify subjects at higher risk of disease (urothelial carcinoma)
- Replace less sensitive urine-based tests (such as urine cytology or other urine genomic tests currently available)
Cxbladder results will not be reported to the subjects or the physicians. Each subject will be required to fill in the date of sample collection in the test-request form and Cxbladder tubes. The site will fill in case-report forms in a professional manner in accordance with good clinical practice (GCP).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is a multicenter, observational study prospectively enrolling up to 1000 subjects with microscopic hematuria (three or more red blood cells per high powered field in one urinalysis; no visible blood in the urine) and gross hematuria (visible blood in the urine) from US sites. This study will be conducted on subjects with microscopic or gross hematuria referred to urology and scheduled for cystoscopy for the investigation of urothelial carcinoma.
Key inclusion criteria (9 listed)
- Subjects who are referred to urology and are either scheduled for a cystoscopy or have had a cystoscopic investigation within the last two months for the evaluation of hematuria meeting ONE of the following criteria:
- EITHER: (a) Microscopic hematuria, confirmed by urine microscopy of three or more RBC/HPF (or equivalent). OR: (b) Gross hematuria.
- Physically able to provide a voided urine sample from a bladder that has not been surgically altered.
- Able to give informed, written consent.
- Able and willing to comply with study requirements (complete at-home urine sampling, fill in test request forms (TRFs) / tube labels and ship urine back to the central laboratory using a prepaid courier service).
Key exclusion criteria (10 listed)
- Prior history of bladder malignancy.
- Reported Cxbladder results within the last six months.
- Prior history of upper tract urothelial carcinoma (UC) or prostatic urethral UC.
- Reconstructed or diverted bladder (e.g., bladder augmentation, ileal conduit, Indiana pouch).
- Subjects aged 89 years of age or older.
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 |
|---|---|---|
| Cxbladder urine testCxbladder tests uses mRNA and DNA biomarkers in the urine to direct the management of UC from diagnosis to surveillance for disease recurrence. | Diagnostic test | – |
Primary outcome
To validate the performance characteristics of Cxbladder Triage Plus in a US cohort which will consist of subjects with a recent history of hematuria and are referred to urology and scheduled for cystoscopy for the evaluation of hematuria.
Time frame: Baseline, pre-intervention / procedure (cystoscopy): Each subject is scheduled for cystoscopy and provides one urine sample for the Cxbladder test pre-procedure
Cxbladder Triage-Plus performance will be measured using performance characteristics such as sensitivity, specificity, negative predictive value and positive predictive value.
2 secondary outcomes
To validate the performance characteristics and Test Negative Rate of Cxbladder Triage Plus through sub-group analysis (gross hematuria, microscopic hematuria, inflammation) for patients with a recent history of hematuria who are undergoing cystoscopy
Time frame: Baseline, pre-intervention / procedure (cystoscopy): Each subject is scheduled for cystoscopy and provides one urine sample for the Cxbladder test pre-procedure
To evaluate the performance characteristics of both Cxbladder Triage Plus and Cxbladder Triage in a pooled analysis with combined results generated at other clinical sites, and to the results of other published clinical studies.
Time frame: Baseline, pre-intervention / procedure (cystoscopy): Each subject is scheduled for cystoscopy and provides one urine sample for the Cxbladder test pre-procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Individual participant dataSharing planned: No. Data will be published in an anonymized report once the study is completed.
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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 (Australia) Pty Ltd
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urothelial Carcinoma, run by Pacific Edge Limited at 3 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 9 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
This study is still under way. Results are not available in the source record yet.
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?
To validate the performance characteristics of Cxbladder Triage Plus in a US cohort which will consist of subjects with a recent history of hematuria and are referred to urology and scheduled for cystoscopy for the evaluation of hematuria. (time frame: Baseline, pre-intervention / procedure (cystoscopy): Each subject is scheduled for cystoscopy and provides one urine sample for the Cxbladder test pre-procedure). 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 16 Sep 2026.