Prediction of Therapeutic Response to Neoadjuvant Chemotherapy in Muscle Invasive Bladder Cancer Patients Using Spatial Transcriptomics
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Identification of responder to neoadjuvant chemotherapy by genetic and molecular profiles
研究概览
简要总结
Although neoadjuvant chemotherapy in muscle-invasive bladder cancer has significantly improved oncological outcomes, approximately 50% of patients do not respond to neoadjuvant chemotherapy, which has adverse effects on patients by causing treatment toxicity and surgical delays. Therefore, treatment tailored specifically to the individual patient based on the genetic and/or molecular profile of the patient is urgently needed. Among patients scheduled for neoadjuvant chemotherapy, the investigators should differentiate between patients who will be highly effective with neoadjuvant chemotherapy and those who will not, and preferentially select other treatments including radical cystectomy in the patients with high probability of failure to neoadjuvant chemotherapy. However, there is no standard which patients would benefit from neoadjuvant chemotherapy. This study plans to predict treatment response to neoadjuvant chemotherapy in patients with muscle-invasive bladder cancer by analyzing genetic and molecular profiles of tumor tissues obtained through transurethral bladder tumor resection.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Identification of responder to neoadjuvant chemotherapy by genetic and molecular profiles
时间窗: At the end of 2 cycles of neoadjuvant chemotherapy (each cycle is 14 days (for ddMVAC) / 28 days (for GC))
Evaluation of the treatment response to neoadjuvant chemotherapy of muscle-invasive bladder cancer patients by imaging (CT and/or MRI) using the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) and correlate with the genetic and molecular profiles of samples (tissue, urine, and blood) analyzed by spatial transcriptomics.
次要结局
- recurrence-free survival of bladder cancer patients who have undergone neoadjuvant chemotherapy and radical cystectomy(within 10 years after the neoadjuvant chemotherapy and radical cystectomy)
- cancer-specific survival of bladder cancer patients who have undergone neoadjuvant chemotherapy and radical cystectomy(within 10 years after the neoadjuvant chemotherapy and radical cystectomy)
- progression-free survival of bladder cancer patients who have undergone neoadjuvant chemotherapy and radical cystectomy(within 10 years after the neoadjuvant chemotherapy and radical cystectomy)
- overall survival of bladder cancer patients who have undergone neoadjuvant chemotherapy and radical cystectomy(within 10 years after the neoadjuvant chemotherapy and radical cystectomy)