NCT01104181已完成不适用
Collection of Anal Specimens for Assessment of Anal Cancer Using the HC2 High-Risk DNA Test (QIAGEN)
Laser Surgery Care1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2010年3月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- HC2 can accurately test for oncogenic HPV in anal specimens
研究概览
简要总结
This is a study to determine if HC2 HPV testing in the anal canal can detect high-risk HPV and whether this aids in identifying individuals are risk for anal cancer or precancerous lesions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male or female 18 years of age or older
- •screened for anal dysplasia, including MSM and women -
排除标准
- •subject has had a previous treatment for anal cancer.
- •subjects that have used enemas or other foreign substances, in the anal canal or anal sex within 24 hours of collection.
- •subjects that have bleeding disorders or use anticoagulation treatments. -
结局指标
主要结局
HC2 can accurately test for oncogenic HPV in anal specimens
时间窗: in approximately 12 months
Determination that HC2 testing in the anal canal can be performed
次要结局
- Sensitivity and specificity of cytology with HC2(in approximately 12 months)
研究者
研究点 (1)
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