Impact of HPV Integration on the Prognosis of Women With Persistent HR-HPV Infection：a Multi-center Cohort Study in China
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 11
- 主要终点
- Human Papillomavirus (HPV) genotyping tests at 6-month follow-up
研究概览
简要总结
Clinically, patients with persistent HR-HPV infection for more than 18 months or HR-HPV infection with CIN2 + need regular colposcopic biopsy to assess the outcome and progression of the disease. A total of 1000 participants with persistent HR-HPV infection (100 cases/center) were recruited from multiple centers, and HPV integration status and vaginal flora diversity were sequenced at baseline, 6th month, 12th month and 24th month, respectively, through prospective cohort studies. And to evaluate the influence of HPV integration status and flora changes on the prognosis of women with persistent HR-HPV infection.
详细描述
This study aims to: 1) determine the association between HPV integration and natural outcome in women with persistent HR-HPV infection. 2) determine the prognostic value of different HPV integration status in women with persistent HR-HPV infection. 3) determine the relationship between the integration status of different HPV genes in the cervix and the diversity of vaginal flora in women with persistent HR-HPV infection, and its prognostic value in women with LSIL and HSIL.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Non pregnant people with sexual history；
- •Persistent infection of the same type of HR-HPV for more than 18 months or HR-HPV infection with CIN2 +;
- •No history of previous surgery at the cervical site.
- •Asexual life, no vaginal medication or flushing before 72 hours of sampling.
排除标准
- •Within 8 weeks after pregnancy or postpartum.
- •Patients with history of genital tract tumor.
- •History of HPV vaccination.
- •Previous history of hysterectomy, cervical surgery, pelvic radiotherapy Historical.
- •In recent one month, she has received genital tract infection, HPV or other STDs treatment related to the infection of mycoplasma.
- •Use antibiotics or vaginal microecological improvement products in recent 1 month.
结局指标
主要结局
Human Papillomavirus (HPV) genotyping tests at 6-month follow-up
时间窗: 6-month follow-up
All participants underwent Human Papillomavirus (HPV) genotyping tests at 6-month follow-up.
Cervical histopathology testing at baseline
时间窗: Baseline
Cervical histopathology was performed at baseline for all participants.
Cervical histopathology testing at 6-month follow-up
时间窗: 6-month follow-up
Cervical histopathology was performed at 6-month follow-up for cervical HR-HPV infection or cytology abnormalities women
Cervical histopathology testing at 12-month follow-up
时间窗: 12-month follow-up
Cervical histopathology was performed at 12-month follow-up for cervical HR-HPV infection or cytology abnormalities women
Human Papillomavirus (HPV) virus integration test at 18-month follow-up
时间窗: 18-month follow-up
Human Papillomavirus (HPV) virus integration test was performed at 18-month follow-up for all participants.
Cervical histopathology testing at 18-month follow-up
时间窗: 18-month follow-up
Cervical histopathology was performed at 18-month follow-up for cervical HR-HPV infection or cytology abnormalities women
Cervical histopathology testing at 24-month follow-up
时间窗: 24-month follow-up
Cervical histopathology was performed at 24-month follow-up for cervical HR-HPV infection or cytology abnormalities women
Human Papillomavirus (HPV) virus integration test at baseline
时间窗: Baseline
Human Papillomavirus (HPV) virus integration test was performed at baseline for all participants.
Human Papillomavirus (HPV) virus integration test at 12-month follow-up
时间窗: 12-month follow-up
Human Papillomavirus (HPV) virus integration test was performed at 12-month follow-up for all participants.
Human Papillomavirus (HPV) virus integration test at 6-month follow-up
时间窗: 6-month follow-up
Human Papillomavirus (HPV) virus integration test was performed at 6-month follow-up for all participants.
Human Papillomavirus (HPV) virus integration test at 24-month follow-up
时间窗: 24-month follow-up
Human Papillomavirus (HPV) virus integration test was performed at 24-month follow-up for all participants.
Cervical cytology testing at baseline
时间窗: Baseline
All participants were tested for cervical cytology at the time of baseline.
Cervical cytology testing at 6-month follow-up
时间窗: 6-month follow-up
All participants were tested for Cervical cytology testing at the time of 6-month follow-up.
Cervical cytology testing at 12-month follow-up
时间窗: 12-month follow-up
All participants were tested for Cervical cytology testing at the time of 12-month follow-up.
Cervical cytology testing at 18-month follow-up
时间窗: 18-month follow-up
All participants were tested for Cervical cytology testing at the time of 18-month follow-up.
Cervical cytology testing at 24-month follow-up
时间窗: 24-month follow-up
All participants were tested for Cervical cytology testing at the time of 24-month follow-up.
Human Papillomavirus (HPV) genotyping tests at baseline
时间窗: Baseline
All participants underwent Human Papillomavirus (HPV) genotyping tests at baseline.
Human Papillomavirus (HPV) genotyping tests at 12-month follow-up
时间窗: 12-month follow-up
All participants underwent Human Papillomavirus (HPV) genotyping tests at 12-month follow-up.
Human Papillomavirus (HPV) genotyping tests at 18-month follow-up
时间窗: 18-month follow-up
All participants underwent Human Papillomavirus (HPV) genotyping tests at 18-month follow-up.
Human Papillomavirus (HPV) genotyping tests at 24-month follow-up
时间窗: 24-month follow-up
All participants underwent Human Papillomavirus (HPV) genotyping tests at 24-month follow-up.
次要结局
- 16SrRNA sequencing of the vaginal secretions at 12-month follow-up(12-month follow-up)
- 16SrRNA sequencing of the vaginal secretions at baseline(Baseline)
- 16SrRNA sequencing of the vaginal secretions at 24-month follow-up(24-month follow-up)
- 16SrRNA sequencing of the vaginal secretions at 6-month follow-up(6-month follow-up)
- 16SrRNA sequencing of the vaginal secretions at 18-month follow-up(18-month follow-up)
研究者
Binhua Dong
Principal Investigator
Fujian Maternity and Child Health Hospital