A Novel Multiplex ELISA Assay for Evaluating Patients With Gross Hematuria for Bladder Cancer

StatusCompleted
PhaseNot specified
Started

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Record History

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  1. Trial completed Show 4 more changesShow less
    • Primary and study completion dates changed from estimate of Jul 2026 to Aug 13, 2026
    • Eligibility criteria expanded, about 10 words
    • Site details revised at 1 of 6 sites
    • Publications: details revised at 3 of 3 entries
  2. Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date: Apr 30, 2026 to Jul 2026
    • Study completion date: Apr 30, 2027 to Jul 2026
    • Site details revised at 6 of 6 sites
    v11
  3. Primary completion date: Dec 30, 2025 to Apr 30, 2026
    • Study completion date: Dec 30, 2025 to Apr 30, 2027
    v10
  4. Study sites: 4 to 6
    • Collaborators: 6 to 8
    v9
  5. Lead sponsor: Charles Rosser to Cedars-Sinai Medical Centerv8
Show 6 earlier versionsHide 6 earlier versions
  1. Collaborators: 5 to 6v7
  2. Re-verified, no change to tracked fieldsv6
  3. Primary completion date: Dec 30, 2021 to Dec 30, 2025
    • Study completion date: Dec 30, 2022 to Dec 30, 2025
    • Collaborators revised (5)
    v5
  4. Collaborators: 2 to 5v4
  5. Study sites: 3 to 4v3
  6. Lead sponsor: University of Hawaii to Charles Rosser
    • Study sites: 1 to 3
    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.
To improve upon the non-invasive detection of BCa by further validating a multiplex ELISA assay directed at a BCa-associated diagnostic signature in voided urine samples of patients with gross hematuria.
Trial Details
NCT Number NCT03193528
Lead Sponsor Cedars-Sinai Medical Center
Collaborators: Fred Hutchinson Cancer Center, University of Texas, Nara Medical University, University of California, Los Angeles, Nonagen Bioscience Corporation, National Cancer Institute (NCI), University of Rochester, Nara Prefecture Seiwa Medical Center
Conditions
(from sponsor)		 Bladder Cancer
Related terms Urinary Bladder Neoplasms
Enrollment 450 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov