The Adjuvant Effect of HPV Vaccination on Recurrence of Cervical Intraepithelial Neoplasia Grade 2 or Worse in Women Undergoing Conization: Retrospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12,000
- 试验地点
- 2
- 主要终点
- CIN2+ recurrence rate
研究概览
简要总结
Assessment of the association between human papillomavirus vaccination (HPV) and recurrences of cervical intraepithelial neoplasia grade 2 or worse (CIN2+) in women undergoing conization.
详细描述
The implementation of vaccination against human papillomavirus (HPV) in the national immunization program for the young age cohort was subsequently extended to previously unvaccinated adult women who underwent conization due to cervical intraepithelial neoplasia grade 2 or worse (CIN2+).
These women are offered HPV vaccination, often completed post-excision. Observational and clinical studies conducted between 2010 and 2023 have demonstrated that HPV vaccination contributes to a >70% reduction in CIN2+ recurrence in women after conization. However, the outcomes of these studies have not conclusively shown whether the adjuvant effect of HPV vaccination depends on the vaccine type (bi-, quadri-, or nona-valent), the timing and completeness of vaccination, and other factors.
This study aims to assess the mentioned factors and potentially reveal new ones, such as age, health status, etc. It is planned to be conducted using the laboratory records of women who underwent conization between 2010 and 2024, with their cervical screening examinations performed at the central laboratory UNILABS in Prague
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women >18 years, with conization for CIN2+ (HSIL)
- •Women who had more than one examination during a follow-up period of >6 months.
排除标准
- •Women who underwent hysterectomy after conization.
- •Women who had excision procedures other than cervical excision.
- •Women who did not undergo any other cytological/histological examinations.
- •Women with more than one conization before CIN2+ recurrence
研究组 & 干预措施
single cohort of women with cervical excision for CIN2+
single cohort of women with cervical excision for CIN2+; those with HPV vaccination and those without HPV vaccination
干预措施: vaccination against human papillomavirus infection (HPV vaccination) (Biological)
结局指标
主要结局
CIN2+ recurrence rate
时间窗: 2010-2024
CIN2+ recurrence rate - obtained from the number of women with this find-ing related the number of women with no finding within the time period since the conization; The recurrence rate of CIN2+ will be assessed in relation to vaccination, vaccine type, vaccination completeness, etc., using specific uni-variate analysis (incidence rate ratio) and multivariate analysis (incidence rate ratio or hazard ratio, as appropriate)
次要结局
- CIN2+ recurrence frequency(2010-2024)