Actively Recruiting
Detection and Risk Stratification in Veterans Presenting With Microscopic Hematuria
Led by Pacific Edge Limited · Updated on 2026-04-24
1000
Participants Needed
4
Research Sites
138 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Detection and Risk Stratification in Veterans Presenting With Microscopic Hematuria
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Referred to urology and scheduled for or had cystoscopy within the last two months for blood in urine meeting one of: microscopic hematuria with three or more red blood cells per high powered field, or gross hematuria
- Physically able to provide a voided urine sample from a bladder without surgical alterations
- Able to give informed, written consent
- Willing and able to comply with study requirements including at-home urine sampling and shipping
- Aged 18 years or older
You will not qualify if you...
- Prior history of bladder cancer
- Cxbladder test results reported within the last six months
- Prior history of upper tract or prostatic urethral urothelial carcinoma
- Reconstructed or diverted bladder (e.g., bladder augmentation, ileal conduit, Indiana pouch)
- Aged 89 years or older
- History of pelvic radiation
- Currently receiving or recently received systemic chemotherapy within six weeks
- Renal failure requiring dialysis
- History of schistosomiasis
- Had intervention such as TURBT or diathermia after a previous cystoscopy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Tri Valley Urology Medical Group
Murrieta, California, United States, 92562
Actively Recruiting
2
AccuMed Research Associates
Garden City, New York, United States, 11530
Actively Recruiting
3
Durham VA Health Care System
Durham, North Carolina, United States, 27705
Actively Recruiting
4
The Urology Place
San Antonio, Texas, United States, 78240
Actively Recruiting
Research Team
A
Ash Maharjan, PhD
CONTACT
A
Alexis White, BSc (Hons)
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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