NCT00743626已完成不适用
Evaluation of the Role of Human Papillomavirus Testing and p16 Expression in the Management of Patients Undergoing Cervical Cancer Screening
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,712
- 试验地点
- 2
- 主要终点
- To provide cervical cancer screening (Pap smear, HPV test and/or p16 tests) to determine whether further intervention (colposcopy) is required
研究概览
简要总结
The principal hypothesis of this study is that HPV testing and/or p16 testing, either alone or in combination or associated with a Pap smear, will demonstrate greater specificity for clinically significant precancerous disease than will a Pap smear alone and that these tests will be of comparable or superior sensitivity than the Pap smear.
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
- Female
- 接受健康志愿者
- 是
入选标准
- •18 years and older
- •Ability to speak and clearly understand English
- •Female patients
排除标准
- •No previous history of Cervical Cancer Treatment(LEEP,Laser,Cone etc.)
- •Women who have had Pap smears within the previous 10 months
- •Women under the age of
- •Women who are pregnant.
- •Inability to give informed consent in English
研究组 & 干预措施
1
Other
Healthy patients screened for cervical cancer
干预措施: Diagnostic cervical cancer screening tests (Pap smear, HPV and/or p16) (Other)
结局指标
主要结局
To provide cervical cancer screening (Pap smear, HPV test and/or p16 tests) to determine whether further intervention (colposcopy) is required
时间窗: 1st visit, 12 months, 18 months follow up
次要结局
未报告次要终点
研究者
研究点 (2)
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