NCT05889195Active, not recruiting
Detection and Risk Stratification in Veterans Presenting With Microscopic Hematuria
Validation of Cxbladder Triage-Plus for the Detection of Urothelial Carcinoma in Subjects With Microscopic Hematuria (microDRIVE)
Source: ClinicalTrials.gov · Last updated 16 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 1000 (estimated)
- First submitted
- 22 May 2023
- Start date
- 2 Nov 2023
- Primary completion date
- 30 Sept 2026
- Lead sponsor
- Pacific Edge Limited
- Diseases
- Bladder cancer
- NCT number
- NCT05889195
What you commit to
- Study type: Observational
- Planned participants: 1000
- From 2 Nov 2023 to the primary completion date, 30 Sept 2026
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior history of bladder malignancy.
- Prior history of upper tract urothelial carcinoma (UC) or prostatic urethral UC.
- Subjects currently receiving systemic chemotherapy or has had systemic chemotherapy within the last six weeks.
- Subjects who have had intervention (TURBT, diathermia, etc.,) following a previous cystoscopy.
Other illness
- Subjects with a history of pelvic radiation.
- Subjects with renal failure on dialysis.
- History of schistosomiasis.
Age
- Subjects aged 89 years of age or older.
Other
- Reported Cxbladder results within the last six months.
- Reconstructed or diverted bladder (e.g., bladder augmentation, ileal conduit, Indiana pouch).
Who the study is looking for
- 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.
- 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
Age in the registry: 18 years to 89 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Durham VA Health Care System Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
| Tri Valley Urology Medical Group Coordinator of this site? Confirm its status | Murrieta | United States | Unknown status |
| The Urology Place Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.