Intended Use Study of the BD SurePath Plus™ Pap
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 5,859
- 试验地点
- 2
- 主要终点
- Sensitivity, Specificity, PPV, and NPV of BD SurePath Plus Pap Test for the Determination of Cervical Disease as Defined by CIN2 or Higher
研究概览
简要总结
This study will provide data on the performance of the BD SurePath Plus™ Pap test for identifying high grade cervical disease. This study will be conducted with approximately 12,500 women undergoing routine cervical cancer screening, of whom women with abnormal cytology and/or positive HPV test will be selected to undergo colposcopy and biopsy/ECC. Subjects with abnormal cytology results with biopsy results of less than or equal to CIN1 or CIN2 untreated will be asked to return in 6-8 months for follow-up testing. Subjects may be asked to proceed to a longer-term follow-up study and undergo cytological evaluation annually for 3 years (separate study).
详细描述
This is a pivotal, multi-center in vitro diagnostic study comparing the BD SurePath Plus Pap test to current practice (cytologic examination utilizing the BD SurePath liquid-based Pap test with conjunctive HPV testing) for the detection of cervical cancer and high-grade cervical disease (collectively referred to as CIN2+) in women.
The new BD SurePath Plus Pap Test combines a traditional Papanicolaou staining for cellular morphology, with brown nuclear immunostaining resulting from the over-expression of specific protein biomarkers, on one slide, to improve the detection of high-grade cervical disease and cervical cancer (collectively referred to as CIN2+).
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
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Study subjects must give voluntary written informed consent to participate in this study.
- •Females ages 18 - 35 years, inclusive; or women at high- risk for cervical cancer or its precursor lesions.
- •High-risk is defined as:
- •Have had a previous high-risk HPV positive test in the last 5 years; or
- •Have had an abnormal Pap test (ASC-US or higher) in the last 5 years; or
- •Have not been screened for cervical cancer by either a Pap test or HPV test in the last 5 years.
排除标准
- •Subjects who are 36 years of age or greater who are not high risk, and/or:
- •Have not had an abnormal Pap in the last 5 years; or
- •Have not had a positive HPV test in the last 5 years; or
- •Have been screened in the last 5 years without an abnormal Pap or HPV result
- •Subjects known to be pregnant or planning to become pregnant prior to the potential six months follow-up visit (self-reported). Subjects who decide to become pregnant prior to the six-month follow up visit or found to be pregnant after the first visit, but prior to the six-month follow-up visit will be terminated from further study participation at that time
- •Subjects who have had a prior complete or partial hysterectomy involving removal of the cervix.
- •Subjects who have had an application of chemical compounds to the cervical area within the 24 hours prior to study entry, e.g., acetic acid, iodine, spermicide, douche, anti-fungal medications, etc.
- •Subjects on whom conization, LEEP, laser surgery, or cryosurgery has been performed within the past five months.
- •Subjects currently undergoing radiation and/or chemotherapy.
- •Subjects under the age of
- •Subjects who have previously received a HPV vaccine with any number of doses.
结局指标
主要结局
Sensitivity, Specificity, PPV, and NPV of BD SurePath Plus Pap Test for the Determination of Cervical Disease as Defined by CIN2 or Higher
时间窗: 10 months
Estimate the sensitivity, specificity, positive predictive value and negative predictive value of the BD SurePath Plus Pap test in detecting cervical disease as defined as CIN2 or higher
次要结局
- Compare the Sensitivity and Specificity of the BD SurePath Plus Pap Test to the SurePath Pap With HPV Reflex Testing for CIN2+ Disease Detection.(10 months)