Detection and Risk Stratification in Veterans Presenting With Microscopic Hematuria

Study acronym: microDRIVE
StatusActive, Not Recruiting
PhaseNot specified
Started

Record status This record was last updated September 16, 2026 (before its estimated September 30, 2026 completion). Its status may not reflect the trial's current state.

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Trial flagged as At Risk
Primary completion moved at least 4 months later May 31, 2026 → Sep 30, 2026
See other at-risk trials from Pacific Edge Limited

Record History

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  1. Enrollment closed, study ongoing Show 5 more changesShow less
    • Primary and study completion dates pushed to Sep 30, 2026
    • Study sites: 4 to 3
    • Eligibility criteria expanded, about 17 words
    • Secondary endpoints: details revised at 2 of 2 entries
    • Study description expanded, about 3 words
  2. Primary completion date: Mar 31, 2026 to May 31, 2026
    • Study completion date: Mar 31, 2026 to Jun 30, 2026
    v8
  3. Primary endpoint revisedv7 Show 5 more changesShow less
    • Primary and study completion dates: Dec 31, 2025 to Mar 31, 2026
    • Eligibility criteria expanded, about 103 words
    • Secondary endpoints: 1 to 2
    • Study description expanded, about 57 words
    • Site contacts updated at 2 of 4 sites
  4. Primary and study completion dates: Mar 2025 to Dec 31, 2025
    • Primary endpoint revised
    • Study sites: 1 to 4
    • Study description shortened, about 2 words
    v6
  5. Primary and study completion dates: Dec 2024 to Mar 2025
    • Site contact updated
    v5
Show 3 earlier versionsHide 3 earlier versions
  1. Primary and study completion dates: May 2024 to Dec 2024
    • Eligibility criteria expanded, about 64 words
    • Site contact updated
    v4
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Nov 2023 to Nov 2, 2023
    • Site details revised
    v3
  3. Start date: Sep 2023 to Nov 2023
    • Primary and study completion dates: Apr 2024 to May 2024
    v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05889195
Lead Sponsor Pacific Edge Limited
Conditions
(from sponsor)		 Urothelial Carcinoma
Related terms Carcinoma, Transitional Cell
Enrollment 1,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov