Longitudinal Bladder Cancer Study for Tumour Recurrence

Study acronym: LOBSTER
StatusActive, Not Recruiting
PhaseNot specified
Started

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Trial flagged as At Risk
Primary completion moved at least 1 year 4 months later May 30, 2026 → Oct 2027
See other at-risk trials from Pacific Edge Limited

Record History

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  1. Primary completion pushed from May 30, 2026 to Oct 2027 Show 6 more changesShow less
    • Primary endpoints: details revised at 1 of 1 entry
    • Enrollment closed, study ongoing
    • Study completion pushed from Aug 31, 2026 to Jan 31, 2028
    • Interventions: CxBladder Monitor/Monitor+ (Diagnostic Test) to CxBladder Monitor/Monitor+ (Diagnostic Test)
    • Eligibility criteria expanded, about 12 words
    • Site details revised at 7 of 7 sites
  2. Re-verified, no change to tracked fieldsv6
  3. Primary endpoint revisedv5 Show 5 more changesShow less
    • Interventions: CxBladder Monitor (Diagnostic Test) to CxBladder Monitor/Monitor+ (Diagnostic Test)
    • Eligibility criteria expanded, about 101 words
    • Study description shortened, about 104 words
    • Site contacts updated at 7 of 7 sites
    • Study title shortened, about 2 words
  4. Primary completion date: Jan 30, 2025 to May 30, 2026
    • Study sites: 2 to 7
    • Study completion date: Dec 31, 2025 to Aug 31, 2026
    v4
  5. Trial status: Active, Not Recruiting to Recruiting
    • Study sites: 1 to 2
    v3
  6. Phase: Not applicable to Not specifiedv2 Show 5 more changesShow less
    • Start date changed from estimate of Dec 1, 2021 to Jun 8, 2022
    • Trial status: Not Yet Recruiting to Active, Not Recruiting
    • Interventions: Cxbladder Monitor (Diagnostic Test) to CxBladder Monitor (Diagnostic Test)
    • Eligibility criteria revised
    • Study description expanded, about 16 words
  7. 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.
Surveillance for recurrence of urothelial carcinoma (UC) requires frequent cystoscopy, which is invasive, expensive and time-consuming. An accurate urinary biomarker has the potential to reduce the number of cystoscopies required during post-treatment surveillance. This is a prospective, single arm, multi-center study using the diagnostic CxBladder test with subjects previously diagnosed with primary or recurrent UC and who are undergoing a schedule of investigative cystoscopies and treatment for the possible recurrence of UC presenting to qualified sites. To evaluate the performance characteristics of the CxBladder test, multiple consecutive urine samples will be collected during the course of surveillance.
Trial Details
NCT Number NCT05080998
Lead Sponsor Pacific Edge Limited
Conditions
(from sponsor)		 Urothelial Bladder Cancer
Related terms Recurrence
Enrollment 450 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov