跳至主要内容
临床试验/NCT07744958
NCT07744958尚未招募不适用

RESTORE-BLADDER (REgistry on STrategies for Organ pREservation in Muscle-invasive BLADDER Cancer)

Heinrich-Heine University, Duesseldorf0 个研究点目标入组 100 人开始时间: 2026年9月1日最近更新:
适应症

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

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

发起方
Heinrich-Heine University, Duesseldorf
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Camilla Grunewald

Dr. med.

Heinrich-Heine University, Duesseldorf

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