Clinical Evaluation of HPV Integration Triage for Detection of Cervical Precancer in HPV-positive Women：a Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,200
- 试验地点
- 1
- 主要终点
- Risk of CIN3+ disease
研究概览
简要总结
The American Society for Colposcopy and Cervical Pathology (ASCCP) recommended HPV testing or co-cytology testing as the standard primary approach for cervical cancer (CC) screening, which is highly sensitive for detection of cervical intraepithelial neoplasia grade 3 or worse. However, in clinical CC screening practice, the specificity and positive predictive value of the ASCCP-recommended strategy is relatively low, which leads to excessive colposcopy and common overtreatment, especially in China with a large number of cervical cancer cases. HPV integration in the host genome is a critical step in cervical carcinogenesis and is highly specific for detection of cervical cancer. Whether HPV integration analysis can play a role in the triage of cervical cancer screening has not yet been investigated.
详细描述
Based on the dilemma of the cervical cancer screening process, in the last five years, our team developed a novel cervical cancer triage strategy and conducted a large cohort study, which evaluated the clinical performance of HPV integration triage alone and in combination with HPV16/18 or HPV16 genotyping of HPV-positive women. We found that the specificity of HPV integration for greater than cervical intraepithelial neoplasia 3 was 94.5%, which was significantly higher than that of cytology (63.8%; P < 0.001) in our previous retrospective study.Here, we conducted a large prospective cohort study evaluating the clinical performance of HPV integration triage of HPV-positive women.
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
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Consenting women aged 20y-70y with HPV-positive results
排除标准
- •Not providing informed consent
- •previously confirmed CIN, cervical cancer, or other malignancies
- •previous therapeutic procedure to cervix
- •pregnancy
结局指标
主要结局
Risk of CIN3+ disease
时间窗: 3 years
CIN3+ diagnosed on biopsy obtained at colposcopy.
Risk of CIN2+ disease
时间窗: 3 years
CIN2+ diagnosed on biopsy obtained at colposcopy.
次要结局
未报告次要终点
研究者
Ding Ma
Chairman of Obstetrics & Gynecology department of Tongji hospital
Tongji Hospital