Factors Associated With Residual Disease In The Central Cone: A Disease Prediction Model
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 397
- 主要终点
- Identify the clinical and pathologic factors associated with residual disease
研究概览
简要总结
Cervical conization using the loop electrosurgical excision procedure (LEEP) is the standard treatment for patients with high-grade cervical intraepithelial neoplasia. Several studies have shown that excising a central cone reduces the rate of positive endocervical margins. The purpose of this study is to identify clinicopathological factors associated with residual disease in the central cone and to develop a predictive model to better determine which patients may require this additional procedure.
详细描述
This study pretends to create a retrospective database including all patient who underwent a loop electrosurgical excision procedure by treatment for high-grade cervical intraepithelial neoplasia and create a a predictive model for top-hat resection in patients with high grade CIN
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •patients who underwent a loop electrosurgical excision procedure (LEEP)
排除标准
- •a diagnosis of micro-invasion or nonsquamous histology
- •less than six months of follow-up
- •incomplete information in their clinical charts.
结局指标
主要结局
Identify the clinical and pathologic factors associated with residual disease
时间窗: 1month
Whit the variables identified as factors associated with the residual disease develop a predictive model to determine which individuals may require additional procedures in the uterine cervix to ensure negative margins.
次要结局
未报告次要终点
研究者
David Cantu
Chief of clinical trial departament
National Institute of Cancerología