Protective Efficacy of HPV Vaccination After Treatment of HPV Related Diseases
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 414
- 试验地点
- 1
- 主要终点
- Persistent HPV infection
研究概览
简要总结
To understand the HPV infection status and subtype distribution of patients, and to study the protective effect of prophylactic HPV vaccination on the recurrence of HPV related diseases after treatment through a prospective cohort study. To provide data support for the primary prevention of HPV related diseases in Chinese women after treatment, and to analyze the related factors of HPV related disease recurrence and HPV continuous positive.
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
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 18-45, of childbearing age or before perimenopause (patients without pregnancy plan within two years);
- •Patients diagnosed as condyloma acuminatum, vaginal intraepithelial lesions (high-grade and low-grade lesions), cervical intraepithelial lesions (high-grade and low-grade lesions), vulvar intraepithelial lesions (high-grade and low-grade lesions), cervical cancer (IA1-IIA2 stage) and treated within 3 months;
- •No surgical contraindications such as severe center of heart, lung and other organ dysfunction and abnormal hemagglutination;
- •Fully know the treatment method, sign informed consent, and actively cooperate with follow-up.
排除标准
- •Participating in other clinical trials;
- •Use immunoglobulin or blood products within 3 months before vaccination;
- •Hypersensitivity to vaccine active ingredients or any dressing ingredients;
- •Acute stage of moderate and severe diseases;
- •Acute stage of severe immune deficiency diseases and autoimmune diseases;
- •Pregnant women and lactating patients;
- •Patients with planned pregnancy within 2 years;
- •Less than 18 years old and more than 45 years old.
结局指标
主要结局
Persistent HPV infection
时间窗: At least 12 months
At least 12 months apart, cervical vaginal / external genital swabs or tissue biopsies were taken for 2 or more consecutive times, and HPV detection and analysis showed that the same HPV type was positive
recurrence
时间窗: 6 months after operation
If The lesions were found again more than 6 months after operation (pathological diagnosis)
次要结局
未报告次要终点