NCT07009327招募中不适用
Efficacy and Safety of Photodynamic Therapy for Cervical Intraepithelial Neoplasia 3(CIN3):A Multicenter Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Efficacy of the treatment
研究概览
简要总结
To investigate the efficacy and safety of photodynamic therapy (20% 5-amino-ketovalerate 630nm red light) in the treatment of cervical intraepithelial neoplasia 3(CIN 3)in women in the real world
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •CIN3, photodynamic therapy was required,
- •type 1 2 transformation area, colposcopy was sufficient
- •the lesion boundary was completely visible
- •The ECC did not indicate high-grade lesions
排除标准
- •coexistence or suspicion of cancer;
- •involving glands
- •Porphyria patients, or suspected allergic to red and blue light.
- •severe medical comorbidities；
结局指标
主要结局
Efficacy of the treatment
时间窗: 1 month after the treatment
colposcopy and biopsy will be performed one month after the treatment. Patients will be categorised as having complete remission(CR) if biopsy confirmed LSIL. If CIN 2 was found after the first course of PDT, it would be categorised as partial remission(PR). Those with the same grade were categorised as persistent disease(PD). The proportion of CR after PDT treatment.
次要结局
未报告次要终点
研究者
研究点 (2)
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