Effect of HPV Integration on Prognosis of Young Women With CIN2 in China: 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
- 300
- 试验地点
- 20
- 主要终点
- Cervical cytology testing at 3-month follow-up
研究概览
简要总结
Clinically, cervical precancerous lesion is one of the important diseases that endanger the life safety and fertility of young women. Women with histopathologically confirmed CIN2 need regular HPV, cervical cytology, and colposcopic biopsy if necessary to assess the outcome and progression of the disease. In this study, we intend to visit Fujian Maternal and Child Health Hospital, Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology and other hospitals, including 300 CIN2 participants aged 45 and below diagnosed by histopathology, and collect the remaining cervical secretions and cervical exfoliated cell samples after clinical examination, even if you do not participate in this clinical study. In clinical diagnosis, treatment and follow-up, it is also necessary to collect the above specimens for relevant medical tests. Therefore, it is of great clinical and scientific significance to explore the role of HPV integrated detection in predicting the prognosis of young women with CIN2.
详细描述
This study aims to:1) determine the correlation between HPV integration and natural outcome in young CIN2 women. 2) determine the prognostic value of different HPV integration status in young women with CIN2. 3) determine the relationship between the integration status of different HPV genes in young CIN2 women and the results of vaginal flora and cervical exfoliative cytology. A prospective cohort of 300 participants under 45 years of age with histopathologically confirmed CIN2 was recruited from multiple centers, and HPV integration status, HPV infection status, cervical cytology, and vaginal flora diversity sequencing were performed at enrollment, 3 months, 6 months, 9 months, and 12 months. The purpose of this study was to evaluate the effect of HPV integration status and flora changes on the outcome and progression of CIN2 women, and to evaluate the correlation between HPV integration status and cervical cytology results.
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
- — 至 45 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women ≤45 years of age with a sexual history.
- •Young woman with histopathologically confirmed CIN
- •No history of cervical conization or total hysterectomy, etc.
- •No sexual experience, vaginal medication or drug flushing within 72 hours before sampling.
排除标准
- •Pregnant and lactating women.
- •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
Cervical cytology testing at 3-month follow-up
时间窗: 3-month follow-up
All participants were tested for cervical cytology at 3-month follow-up.
Cervical cytology testing at 6-month follow-up
时间窗: 6-month follow-up
All participants were tested for cervical cytology at 6-month follow-up
16SrRNA sequencing of the vaginal secretions at baseline
时间窗: Baseline
All participants underwent vaginal secretion sequencing at baseline.
16SrRNA sequencing of the vaginal secretions at 3-month follow-up
时间窗: 3-month follow-up
All participants underwent vaginal secretion sequencing at 3-month follow-up.
Cervical histopathology testing at baseline
时间窗: Baseline
Cervical histopathology was performed at baseline for all participants.
Human Papillomavirus (HPV) viral integration test at baseline
时间窗: Baseline
Human Papillomavirus (HPV) viral integration test was performed at baseline for all participants.
Cervical cytology testing at 9-month follow-up
时间窗: 9-month follow-up
All participants were tested for cervical cytology at 9-month follow-up
16SrRNA sequencing of the vaginal secretions at 12-month follow-up
时间窗: 12-month follow-up
All participants underwent vaginal secretion sequencing at 12-month follow-up
Human Papillomavirus (HPV) viral integration test at 6-month follow-up
时间窗: 6-month follow-up
Human Papillomavirus (HPV) viral integration test was performed at 6-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 histopathology testing at 6-month follow-up
时间窗: 6-month follow-up
Cervical histopathology was performed at 6-month follow-up for all participants.
16SrRNA sequencing of the vaginal secretions at 6-month follow-up
时间窗: 6-month follow-up
All participants underwent vaginal secretion sequencing at 6-month follow-up
Human Papillomavirus (HPV) genotyping tests at 3-month follow-up
时间窗: 3-month follow-up
All participants underwent Human Papillomavirus (HPV) genotyping tests at 3-month follow-up.
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 all participants.
Human Papillomavirus (HPV) viral integration test at 12-month follow-up
时间窗: 12-month follow-up
Human Papillomavirus (HPV) viral integration test was performed at 12-month follow-up for all participants.
Cervical cytology testing at 12-month follow-up
时间窗: 12-month follow-up
All participants were tested for cervical cytology at 12-month follow-up
16SrRNA sequencing of the vaginal secretions at 9-month follow-up
时间窗: 9-month follow-up
All participants underwent vaginal secretion sequencing at 9-month follow-up
Human Papillomavirus (HPV) genotyping tests at 9-month follow-up
时间窗: 9-month follow-up
All participants underwent Human Papillomavirus (HPV) genotyping tests at 9-month follow-up.
Human Papillomavirus (HPV) genotyping tests at baseline
时间窗: Baseline
All participants underwent Human Papillomavirus (HPV) genotyping tests at baseline.
次要结局
未报告次要终点
研究者
Binhua Dong
Principal Investigator
Fujian Maternity and Child Health Hospital