Immunogenic Cell Death as a Novel Mechanism of Mitomycin C Activity in Bladder Cancer
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- MMC-induced ICD
研究概览
简要总结
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
详细描述
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:
- identify an expression profile that is common to all tumors that undergo ICD upon MMC treatment ('ICD signature'),
- asses the genetic and environmental factors- urinary microbiome composition- responsible for MMC treatment efficacy,
- 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).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and females, > 40 years old
- •For bladder cancer patients:
- •bladder cancer patients- patinets with first tumor occurrence or patient with a recurrence after more than 2 years from the removal of the prior malignancy
排除标准
- •Treated with immunomodulatory agents at time of enrollment or in the two months before enrollment
- •Treated with antibiotics at time of enrollment or during the month before enrollment
- •Positive history of sexually transmitted diseases
- •Urinary infection ongoing or recent (during the three months before enrollment)
- •Suffering from chronic intestinal inflammation
- •ONLY for controls:
- •Treated with immunomodulatory agents at time of enrollment or in the two months before enrollment
- •Treated with antibiotics at time of enrollment or during the month before enrollment
- •Positive history of sexually transmitted diseases
- •Urinary infection ongoing or recent (during the three months before enrollment)
- •Suffering from chronic intestinal inflammation
结局指标
主要结局
MMC-induced ICD
时间窗: 3 years
The main aim of this study is to evaluate whether MMC is able to trigger ICD in patient-derived neoplastic tissues.
次要结局
- ICD signature analyzed by RNAseq analysis(3 years)
- Microbiota study(3 years)
研究者
Michele Tedeschi
Head of Clinical Research
Istituto Clinico Humanitas