NCT01058460Unknown不适用
A Randomized Controlled Trial Comparing Concomitant HPV-cytology Testing With Conventional Cytology Testing for the Detection of High Grade Cervical Intraepithelial Neoplasia in Primary Cervical Cancer Screening in Hong Kong
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 12,000
- 试验地点
- 1
- 主要终点
- Histological CIN2, CIN3 and cervical carcinoma
研究概览
简要总结
To compare the effects of conventional cytology testing with concommitant HPV-cytology testing for the detection of high grade cervical lesions in primary cervical cancer screening in Hong Kong
Hypotheses:
- There is a significant difference in the number of CIN2+ cases detected between the cytology testing group and the cytology-HPV co-testing group at baseline.
- Significantly more CIN2+ cases will be detected at the second round of screening among participants with normal cytology result in the control arm than those with normal cytology and negative HPV results in the intervention arm.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Ethnic Chinese women aged 30 to 60 years who have completed a written consent
- •Women who have not attended screening for the past 3 years or more will be given priority
排除标准
- •Currently pregnant
- •Without a cervix
- •Congenital abnormalities of the lower genital tract
- •Previous history of invasive cervical cancer
- •Who has been followed-up or treated for an abnormal cytology result in the past 12 months
- •Who are unable to provide consent
结局指标
主要结局
Histological CIN2, CIN3 and cervical carcinoma
时间窗: At baseline and each subsequent follow-up
次要结局
- Clearance of mild cervical abnormalities among HPV negative subjects(At baseline and 1-year after)
研究者
研究点 (1)
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