Clinical Evaluation of the APTIMA® HPV Assay on the TIGRIS® DTS® System in Women With ASC-US Pap Test Results and in Women 30 Years of Age or Older With Negative Pap Test Results Using ThinPrep Pap Test Specimens
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 12,896
- 试验地点
- 34
- 主要终点
- Adjunct Study Arm: Compare Assay Performance for FDA-Approved HPV DNA Assay to a FDA-Approved HPV Assay for Detecting CIN2+
研究概览
简要总结
The purpose of this study is to provide data on the performance of the APTIMA HPV Assay using the TIGRIS System in detecting HPV types that may cause cervical cancer.
详细描述
The primary objective of the clinical trial is to evaluate the APTIMA HPV Assay, using the TIGRIS System, in cervical cancer screening programs. This will be achieved by determining the performance of the assay for detecting high-risk human papillomavirus (HPV) types in women with known cervical disease status. The assay will be evaluated in sample populations of women with ASC-US Pap test results ("ASC-US results") and women 30 years of age or older ("30+ years of age") with negative (NILM) cytology results.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female 21 years or older (ASC-US study only)
- •Female 30 years or older (Adjunct and ASC-US studies)
- •Subject attending a participating clinic and undergoing a Pap screening exam during the clinic visit
- •Ability to comprehend and sign an IRB-approved Informed Consent Form
排除标准
- •Diagnosis of cervical disease (cancer or precancerous condition) in the past 12 months
- •Abnormal Pap test result in the past 12 months
- •Subject under 18 years of age and consenting to the study without the presence of their parent or legal guardian
- •Known to be pregnant
- •Having an illness or medical condition that could interfere with or affect the conduct, results, and/or completion of the clinical trial
- •Having an illness or medical condition that the investigator or physician feels would create an unacceptable risk to the subject if she enrolled into the clinical trial
- •Prior vaccination for HPV
结局指标
主要结局
Adjunct Study Arm: Compare Assay Performance for FDA-Approved HPV DNA Assay to a FDA-Approved HPV Assay for Detecting CIN2+
时间窗: Baseline Evaluation
Adjunct Study Arm: 30+ yrs. Population: FDA-Approved HPV DNA Assay Performance for Detecting CIN2+: Compare Clinical Performance of the Aptima HPV Assay to a FDA-Approved HPV Assay for Detecting CIN2+
Adjunct Study Arm: Compare Assay Performance for Aptima HPV Assay to a FDA-Approved HPV Assay for Detecting CIN2+
时间窗: Baseline Evaluation
Adjunct 30+ yrs. Population: Aptima HPV Assay Performance for Detecting CIN2+: Compare Clinical Performance of the Aptima HPV Assay to a FDA-Approved HPV Assay for Detecting CIN2+
次要结局
- ASC-US Study Arm: Aptima HPV Assay Performance for Detecting CIN2+ (All Biopsies)(Baseline Evaluation)
- ASC-US Study Arm: FDA-Approved HPV DNA Assay Performance for Detecting CIN2+ (All Biopsies)(Baseline Evaluation)