Precise Chemoresection in Low-grade NMIBC Using Drug Screens in Patient-derived Organoids

Study acronym: POLO
StatusNot Yet Recruiting
PhasePhase 2
Started

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Trial flagged as At Risk
Primary completion moved at least 4 years 1 month later Oct 2026 → Nov 30, 2030
See other at-risk trials from Hospital Centre Biel/Bienne

Record History

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  1. Primary completion pushed from Oct 2026 to Nov 30, 2030 Show 8 more changesShow less
    • Sponsor changed: University of Bern to Hospital Centre Biel/Bienne
    • Start date: Oct 2024 to Dec 1, 2026
    • Study completion pushed from Oct 2029 to Nov 30, 2031
    • Study sites: 1 to 2
    • Eligibility criteria expanded, about 135 words
    • Secondary endpoints: 3 to 5
    • Collaborators: 1 to 3
    • Study title expanded, about 4 words
  2. 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.
Based on the unmet clinical need to reduce invasiveness of treatment of low grade NMIBC, the investigators conduct this prospective, open label, single arm and single center phase II trial. The investigators aim to use drug screens in PDOs to guide neoadjuvant intravesical instillation therapy with either Epirubicin, Mitomycin C, Gemcitabine or Docetaxel to achieve chemoresection NMIBC.
Trial Details
NCT Number NCT06227065
Lead Sponsor Hospital Centre Biel/Bienne
Collaborators: Spitalzentrum Biel, Lindenhofgruppe AG, Fond'action contre le cancer
Conditions
(from sponsor)		 Bladder Cancer, Non-muscle Invasive Bladder Cancer, Low Grade
Related terms Non-Muscle Invasive Bladder Neoplasms, Urinary Bladder Neoplasms
Enrollment 28 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov