Can We Predict of the Response of High Risk Non Muscle Invasive Bladder Cancer Patients to Intravesical Bacillus Calmette-Guerin? The Role of Immunological Markers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 204
- 试验地点
- 2
- 主要终点
- Progression
研究概览
简要总结
Intravesical BCG is the mainstay adjuvant management of high risk NMIBC. Adequacy of immune system stimulation is the determinant factor for patient response to BCG. Immunological markers for BCG-response could be helpful for urologists especially in the era of BCG shortage.
Objectives: To assess the predictive performance of different immunological markers on BCG-response in high risk NMIBC BCG-naïve patients.
详细描述
Background: Intravesical BCG is the mainstay adjuvant management of high risk NMIBC. Adequacy of immune system stimulation is the determinant factor for patient response to BCG. Immunological markers for BCG-response could be helpful for urologists especially in the era of BCG shortage.
Objectives: To assess the predictive performance of different immunological markers on BCG-response in high risk NMIBC BCG-naïve patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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 with primary or recurrent NMIBC for whom primary TURBT was done.
排除标准
- •Patients with previous BCG instillation,
- •benign pathology
- •Variant histology
- •Non urothelial carcinoma,
- •concommitent upper tract urothelial tumors, detrusor muscle invasion
- •low or intermediate risk NMIBC
结局指标
主要结局
Progression
时间窗: 1 year
persistent/recurrent tumor during or after treatment with increasing tumor grade or upstaging to muscle invasion after initial complete response
Initial BCG complete response
时间窗: 3 months
free cystoscopy/negative cytology at 3 months.
Recurrence
时间窗: 1 year
Recurrence is defined as development of new tumor/positive cytology in patients with ICR
次要结局
未报告次要终点
研究者
Amr Abdel-Lateif El-Sawy
Principal Investigator
Mansoura University