Bladder Cancer Clinical Trial
Official title:
Immunogenic Cell Death as a Novel Mechanism of Mitomycin C Activity in Bladder Cancer
The principal objective of this study consists in the assessment of Immunogenic Cell Death (ICD) induction in neoplastic tissues derived from bladder cancer patients treated ex vivo with Mitomycin C (MMC). The evaluation is performed using cellular and molecular analyses of treated versus untreated samples derived from the same patient
Urothelial or transitional cell carcinoma of the bladder is the fourth most common cancer in
males worldwide, with about 60-80% of newly diagnosed patients having non-muscle-invasive
bladder cancer (NMIBC). NMIBC management consist in transurethral resection of bladder tumor
(TURBT) followed by adjuvant intravesical treatment with the chemotherapeutic agent Mitomycin
C (MMC) or the immunotherapy bacillus Calmette-Guérin. These therapies result in low
progression rates, but are not efficacious in all patients, leading to high tumor recurrence.
Immunogenic cell death (ICD) may be one of the mechanisms of action of MMC intravesical
therapy in bladder cancer.
The primary objective of the study is to evaluate whether MMC is able to trigger ICD in
patient-derived neoplastic tissues. As secondary targets we aim to:
1. identify an expression profile that is common to all tumors that undergo ICD upon MMC
treatment ('ICD signature'),
2. asses the genetic and environmental factors- urinary microbiome composition- responsible
for MMC treatment efficacy,
3. evaluate whether ICD induction correlates with clinical staging and response (clinical
endpoints for MMC-treated patients are recurrence at three month and one year after
enrollment).
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