Trial23 - A Method Study on the Use of Primary HPV-testing With Cytology Triage in Women Offered HPV-vaccination as Girls
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 7,000
- 试验地点
- 2
- 主要终点
- Cumulative CIN3+ (cervical intraepithelial neoplasia grade 3 and above) in baseline screen-negative women.
研究概览
简要总结
In Denmark, the first birth cohorts of women offered HPV-vaccination as girls are entering the cervical screening program. These women are expected to be better protected against cervical cancer. It has not yet been decided how to screen these women.
This method study will investigate a possible screening scheme that could provide a reduced burden of screening for HPV-vaccinated birth cohorts.
详细描述
In Denmark, women aged 23-49 are offered cervical screening with liquid-based cytology (LBC) every 3rd year, and women aged 50-59 every 5th year. Women aged 60-64 are offered an exit HPV-DNA test.
In 2008 vaccination against Human papilloma virus (HPV) was offered free of charge to girls aged 13-15. HPV-vaccination has been part of the child vaccination program for 12-year old girls since 2009. Women born in 1994 were offered HPV-vaccination at age 14, and approximately 80% are HPV-vaccinated. These women entered the screening program in 2017.
HPV-testing is shown to provide a better protection against cervical cancer than cytology testing, and the 6-year protection against CIN3+ after a negative HPV-test has been observed to be higher than the 3-year protection after a negative cytology test (ref).
The aim of the study is to evaluate if primary screening with HPV-testing and LBC triage every 6 years in women offered HPV-vaccination as girls would provide at least the same protection as the present screening, measured by cumulative number of cervical intraepithelial neoplasia (CIN). This screening scheme would allow HPV-negative women to benefit from a prolonged screening interval and thereby reduce the burden of screening for HPV-vaccinated birth cohorts.
The study is deemed a method study by the ethical committee of the Capital region and informed consent is, therefore, not required. The study is approved by the Danish data protection agency.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 23 Years 至 23 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women born in 1994 living in the study area
排除标准
- •None, as it is a public health trial
结局指标
主要结局
Cumulative CIN3+ (cervical intraepithelial neoplasia grade 3 and above) in baseline screen-negative women.
时间窗: After up to 9 years follow-up (end-of-study)
Histologically proven CIN3+ is chosen as primary outcome measure because it is the diagnostic threshold above which conization is recommended by the Danish Society of Gynecology and Obstetrics. Primary outcome will be based on intention-to-treat and per protocol analysis and stratified by region of residence. Primary HPV-testing with cytology triage every six years compared to cytology every three years will be approximated from the observed data.
次要结局
- Cumulative CIN1 (cervical intraepithelial neoplasia grade 1) overall(After up to 9 years follow-up (end-of-study))
- Cumulative CIN3+ overall(After up to 9 years follow-up (end-of-study))
- Cumulative CIN2 in baseline screen-negative women(After up to 9 years follow-up (end-of-study))
- Cumulative CIN1 in baseline screen-negative women(After up to 9 years follow-up (end-of-study))
- Cumulative CIN2 (cervical intraepithelial neoplasia grade 2) overall(After up to 9 years follow-up (end-of-study))
研究者
Elsebeth Lynges
Professor
University of Copenhagen