NCT03158480Unknown不适用
Safety and Efficacy of Immune Therapy for Condyloma
Shenzhen Second People's Hospital1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2017年6月25日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Condylomata Acuminata recurrence rate
研究概览
简要总结
Cytokine-induced killer (CIK) cells will be co-cultured with HPV induced dendritic cells (DCs); HPV specific DC-CIK will be induced to Condylomata Acuminata patients using interferon, whose recurrence rate and total cost will be compared to Condylomata Acuminata patients only use interferon.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients have typical clinical characters of condyloma, positive for HPV-DNA test; All patients have been treated for cryotherapy or laser plus interferon for over half a year without completely recovery. All patients or their family will sign informed consent and approved by Ethics Committee of Shenzhen Second People's Hospital -
排除标准
- •pregnant, blood disease, contraindication for immune therapy, allergic to interferon
结局指标
主要结局
Condylomata Acuminata recurrence rate
时间窗: 6 months
Condylomata Acuminata recurrence rate in 6 months after treatment
次要结局
- side effect(6 months)
- skin tissue HPV gene(6 months)
研究者
研究点 (1)
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