Malvacdecision.Net
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 191
- 试验地点
- 1
- 主要终点
- Nature of smear: normal or not (including ASCUS and AGC) according to their immunization status
研究概览
简要总结
In France, the vaccination coverage observed for HPV vaccination is low for a full-scale regimen, and has been falling since 2010. A high rate of HPV vaccination coverage has a significant epidemiological impact with a reduction in cervical cancer mortality.
There is less data on vaccinated catch-up patients. In 2017, these patients are 25 years of age or older and carry out screening smears.
The aim of this study is to demonstrate whether HPV catch-up vaccination results in a decrease in the abnormal smear rate compared to the rate in unvaccinated patients.
If so, these data will help mobilize doctors to vaccinate patients against HPV, even in catching-up.
详细描述
In France, the observed vaccination coverage is very low for a complete regimen and has been declining since 2010. This low coverage makes it impossible to benefit from the efficiency observed in the other countries.
Indeed, a high HPV vaccination coverage rate would allow an epidemiologically significant impact with a reduction in cervical cancer mortality. In France, it is estimated that the vaccination of 80% of girls between the ages of 11 and 14 would reduce the incidence of 72% of CIN2 and 54% of CIN3.
Nevertheless, there is less data on patients who have been vaccinated in catch-up. These patients are 25 years of age or older in 2017, and make smears.
The aim of this study is to demonstrate whether HPV catch-up vaccination results in a decrease in the abnormal smear rate compared to the rate in unvaccinated patients.
If our study shows the benefits of catch-up vaccination, these data will help to mobilize doctors to vaccinate girls 15-19 years of age against HPV if they have not been able to benefit between 11 and 14 years as recommended.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 25 Years 至 33 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •aged 25 to 33 in 2017
- •with a smear analyzed at the Brest University Hospital
排除标准
- •age over 33 years or less than 25 years
- •patient refusing to participate
结局指标
主要结局
Nature of smear: normal or not (including ASCUS and AGC) according to their immunization status
时间窗: Day 1
次要结局
- Vaccine received(Day 1 (questionnaire completed by patient))
- age of occurrence of lesions according to the year of vaccination(Day 1 (questionnaire completed by patient))
- number of injection received(Day 1 (questionnaire completed by patient))
- Age of onset of sexual activity(Day 1 (questionnaire completed by patient))