NCT00213655已完成不适用
Clinical Evaluation of Maintenance BCG Immunotherapy in Superficial Bladder Tumors
University Hospital, Rouen1 个研究点 分布在 1 个国家目标入组 146 人开始时间: 2004年6月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 146
- 试验地点
- 1
- 主要终点
- Tumoral response
研究概览
简要总结
Evaluation of maintenance BCG immunotherapy (dose 27 mg) in superficial bladder tumors. Two randomized arms (every 3 or 6 months) will be studied for a population of 300 patients.
详细描述
BCG maintenance immunotherapy 1/3 dose : 27 mg two randomized arms : 3 or 6 months for 36 months clinical side effects according to OMS score efficacy regarding recurrence : cytology and cystoscopy PSA, leucocyturia and N-ramp gene evaluation
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ta and T1 bladder tumors
排除标准
- •BCG contra-indications
结局指标
主要结局
Tumoral response
时间窗: Month 36
Tumoral response assessed at M36
次要结局
- Tumoral response(Month 24)
研究者
研究点 (1)
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