Evaluation of the Cobas® 4800 HPV Test for the Detection of High-grade Cervical Disease in Women Undergoing Routine Cervical Cancer Screening
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 47,208
- 试验地点
- 61
- 主要终点
- Percentage of Participants With a Diagnosis of ≥ CIN2
研究概览
简要总结
This study provided data on the performance of the Cobas® 4800 HPV Test for identifying histologically confirmed high-grade cervical disease. The baseline, cross-sectional phase was conducted in approximately 45,000 women undergoing routine cervical cancer screening, of whom approximately 7,400 were selected to undergo colposcopy and biopsy/endocervical curettage (ECC) at baseline. These subjects included women with cytology that is 'not normal' and a selection of those with 'normal' cytology who entered a follow-up phase and underwent cytological evaluation annually for 3 years. In this follow-up phase, colposcopy and biopsy/ECC were performed only in women with cervical cytology considered 'not normal' at any of the annual follow-up visits.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Females ≥ 21 years of age presenting for routine cervical cancer screening.
- •An intact cervix.
- •Willing and able to undergo colposcopy and biopsy and endocervical curettage within 8 weeks after study Visit 1.
排除标准
- •Known pregnancy at study Visit
- •Presenting for colposcopy at study Visit
- •Any condition resulting in increased risk of bleeding at biopsy.
- •Hysterectomy.
- •Known history of ablative or excisional therapy to the cervix within the preceding 12 months.
结局指标
主要结局
Percentage of Participants With a Diagnosis of ≥ CIN2
时间窗: Baseline to the end of the Baseline period (up to 12 weeks)
A diagnosis of ≥ CIN2 (cervical intraepithelial neoplasia) included histology results of CIN2, CIN3, adenocarcinoma in situ, squamous cell carcinoma, or adenocarcinoma. The diagnosis was based on central pathology review.
次要结局
- Percentage of Participants With a Diagnosis of ≥ CIN3(Baseline to the end of the study (up to 5 years, 1 month))