RESTORE-BLADDER (REgistry on STrategies for Organ pREservation in Muscle-invasive BLADDER Cancer)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 主要终点
- 2 year MFS
研究概览
简要总结
Removal of the urinary bladder (radical cystectomy) is a major surgical procedure that can have a permanent impact on a patient's quality of life. Consequently, some patients, despite having received comprehensive counseling and completing systemic therapy, decide against subsequent surgery or alternative radiotherapy. Recent scientific studies suggest that, for selected patients, an attempt at bladder preservation may be a medically justifiable option. However, it remains unclear which patients are truly suitable candidates for bladder-preserving management and which are not. The aim of this registry is therefore to collect and analyze clinical data from this specific patient population.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged >= 18 years, capable of providing informed consent
- •Histologically confirmed muscle-invasive urothelial carcinoma of the urinary bladder
- •Received perioperative systemic therapy in accordance with current guidelines and subsequently decline cystectomy or radiotherapy
排除标准
- •Age < 18 years
- •Lack of capacity to provide informed consent
- •No histological confirmed muscle-invasive urothelial carcinoma
- •No prior preoperative systemic therapy
结局指标
主要结局
2 year MFS
时间窗: 2 Years
Metastatic free survival after two years
次要结局
未报告次要终点
研究者
Dr. Camilla Grunewald
Dr. med.
Heinrich-Heine University, Duesseldorf
