NCT01709773已完成不适用
Focal Ablation of High-grade Cervical Intraepithelial Neoplasia
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Six-month recurrence rate of high-grade cervical intraepithelial neoplasia
研究概览
简要总结
This is a pilot cohort study of women undergoing focal ablation for high-grade cervical intraepithelial neoplasia (HGCIN). The cohort was recruited from the UCSF Dysplasia Clinics. The standard treatment involves treatment of the entire cervix. Women with HGCIN meeting inclusion criteria were recruited for enrollment into the pilot study of focal treatment. Upon enrollment, they underwent focal ablational treatment rather than standard ablational treatment of the cervix. Follow-up visits were conducted at 2 weeks and 6 months to assess safety, feasibility, and acceptability. The 6-month recurrence rate of HGCIN will be calculated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 21-45 yo
- •Biopsy-confirmed high grade cervical intraepithelial neoplasia grade 2, 3, or 2/3
- •Satisfactory colposcopy, i.e., the entire transformation zone is visible
- •Lesion occupying <= 2 quadrants of the cervix.
排除标准
- •Unsatisfactory colposcopy.
- •Colposcopic lesion extending into the endocervical canal beyond colposcopic visualization.
- •Endocervical curettage positive for high-grade cervical intraepithelial neoplasia.
- •Suspicion for invasive cancer on colposcopic exam.
- •Glandular dysplasia or atypical glandular cells on cytology.
- •Unreliable for follow-up.
- •Immunosuppression (HIV, transplant recipient, etc.)
结局指标
主要结局
Six-month recurrence rate of high-grade cervical intraepithelial neoplasia
时间窗: six months
次要结局
- Feasibility of focal treatment(enrollment)
- Safety of focal treatment(six months)
- Acceptability of focal treatment(six months)
研究者
研究点 (2)
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