Multi-center Prospective Observational Study for the Validation of Preoperative Low-risk Criteria for Lymph Node Metastasis in Endometrial Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 529
- 试验地点
- 1
- 主要终点
- Diagnostic odds ratio
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of low risk criteria for lymph node metastasis, that was determined by KGOG-2014 retrospective study, in women with endometrial cancer.
详细描述
The Korean Gynecologic Oncology Group (KGOG) undertook a multi-center retrospective study to develop a preoperative prediction model for lymph node metastasis in endometrial cancer (KGOG-2014). This retrospective multi-center study showed that the accurate identification of a low-risk group for lymph node metastasis among the patients with endometrial cancer can be achieved with the new criteria using preoperative MRI and serum CA-125 assay. In this study, serum CA125 levels and three MRI parameters (deep myometrial invasion, lymph node enlargement, and extension beyond uterine corpus) were found to be independent risk factors for nodal metastasis. Based on the success of KGOG-2014, Korean Gynecologic Oncology Group initiated this prospective, multi-center observational study to validate our prior prediction model.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with a histologic diagnosis of endometrial cancer before surgical staging.
- •Patients with a preoperative magnetic resonance imaging (MRI) and serum CA-125 within 4 weeks from surgical staging.
- •Patients who underwent adequate systemic lymph node dissection during surgical staging.
排除标准
- •Patients with a histologic feature suggesting sarcoma or squamous cell carcinoma
结局指标
主要结局
Diagnostic odds ratio
时间窗: 2014-12-31
Sensitivity/Specificity
时间窗: 2014-12-31
Negative predictive value
时间窗: 2014-12-31
次要结局
未报告次要终点
研究者
Sokbom Kang
Director, Gynecologic Oncology Research Div.
National Cancer Center, Korea