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Xpert Bladder Monitor: a Non-Invasive Follow-Up Tool for Detecting Relapse in High Grade or High Risk Bladder Cancer
Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Summary
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2025-01-01
Completion Date
2032-01-01
Last Updated
2024-12-30
Healthy Volunteers
No
Conditions
Interventions
Urinary biomarkers
In a bid to reduce or replace surveillance cystoscopies multiple urinary biomarkers have been evaluated for the follow-up of the bladder cancer patients. These device will reduce the number of cystoscopies