NCT04256616

Immunogenic Cell Death as a Novel Mechanism of Mitomycin C Activity in Bladder Cancer

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 110 (estimated)
• Sponsor: Istituto Clinico Humanitas · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

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).

Conditions

• Bladder Cancer

Interventions

Type	Name	Description
OTHER	This is an observational study that does not concern a direct intervention on patients and control subjects and does not interfere with the clinical management of patients.	urine collection: DNA is isolated from urine samples (catheterized, washout, midstream) and the 16S rRNA gene is sequenced. Specimen collection: Specimens collected during TURBT are selected by a pathologist and trasferred to the laboratory. The tissues are treated ex vivo with MMC.

Timeline

• Start date: 2018-06-27
• Primary completion: 2020-09-01
• Completion: 2020-09-30
• First posted: 2020-02-05
• Last updated: 2020-07-07

Locations

1 site across 1 country: Italy