Ignite Creation Date:
2025-12-26 @ 11:46 AM
Ignite Modification Date:
2025-12-26 @ 11:46 AM
Study NCT ID:
NCT04256616
Status:
UNKNOWN
Last Update Posted:
2020-07-07
First Post:
2020-02-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Immunogenic Cell Death as a Novel Mechanism of Mitomycin C Activity in Bladder Cancer
Sponsor:
Istituto Clinico Humanitas
Organization:
Study Overview
Official Title:
Immunogenic Cell Death as a Novel Mechanism of Mitomycin C Activity in Bladder Cancer
Status:
UNKNOWN
Status Verified Date:
2020-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ICH-MIM-01
Brief 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).
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).
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: