HPV Testing as a Prevention of Cervical Dysplasia and Cervical Cancer Before Planned Subtotal Hysterectomy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
- 主要终点
- Benefit of addition of HPV DNA testing before subtotal hysterectomy
研究概览
简要总结
Patients indicated for subtotal hysterectomy will be tested for High risk HPV and if the result is positive will undergo expert colposcopy and conisation if not indicated otherwise at the time of subtotal hysterectomy
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •age over 18
- •indication for subtotal hysterectomy
- •consent to provide conisation in case the HPV test result is positive
排除标准
- •negative HPV test in the last 3 years
结局指标
主要结局
Benefit of addition of HPV DNA testing before subtotal hysterectomy
时间窗: 3 years
Prevalence of HPV positivity in the tested cohort (patients indicated for subtotal hysterectomy). Prevalence of HPV (other than HPV 16 and 18) positivity in the tested cohort (patients indicated for subtotal hysterectomy). Prevalence of abnormal oncological cytology result and correlation to HPV result in the tested cohort (patients indicated for subtotal hysterectomy). Prevalence of cervical intraepithelial leasions in patients who underwent cone biopsy with the subtotal hysterectomy. Prevalence of high grade cervical intraepithelial leasions in patients who underwent cone biopsy with the subtotal hysterectomy. Rate of HPV negativity 6 months after cone biopsy.
次要结局
未报告次要终点
研究者
Tomáš Fučík
Tomas Fucik M.D.
General University Hospital, Prague