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Xpert Bladder Monitor: a Non-Invasive Follow-Up Tool for Detecting Relapse in High Grade or High Risk Bladder Cancer

Study acronym: LIBERO
StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
Main objectives: Qualitative and quantitative monitoring of recurrences in patients with a previous diagnosis of high-grade bladder cancer at high risk of persistence/recurrence. Endpoints: Presence or absence of mRNA in urine with a dichotomous result; concordance between Xpert BM and histopathological examination Clinical relevance: reduces by half the number of (invasive) cystoscopies during follow-up. The non-invasive nature of the test could improve patient compliance with follow-up. Interventional study because it would reduce by half the number of cystoscopies during follow-up of bladder cancer which is considered the gold standard in the follow-up of this tumor. However, these markers are already CE validated and described in the European guidelines and for this reason the risk would be low.
Trial Details
NCT Number NCT06751667
Lead Sponsor Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Conditions
(from sponsor)		 Bladder (Urothelial, Transitional Cell) Cancer, Bladder Cancer, Bladder Tumors, Bladder Cancer Recurrence, Cystoscopy
Related terms Neoplasms, Urinary Bladder Neoplasms
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov