Validating The Prognostic Role of ATR Mutation in Patients With Endometrioid Endometrial Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,824
- 试验地点
- 1
- 主要终点
- ATR mutation status
研究概览
简要总结
This research study is studying prognostic biomarkers in tissue samples from patients with endometrial cancer. Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
详细描述
PRIMARY OBJECTIVES:
I. To validate the clinicopathologic associations and prognostic significance of ATR mutation in endometrioid endometrial cancer cases with defective DNA mismatch repair.
OUTLINE: This is a multicenter study.
DNA extracted from previously collected tumor samples is analyzed to validate the clinicopathologic associations and prognostic significance of ATR mutation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women who were eligible and evaluable for the GOG-0210 molecular staging protocol in women with endometrial cancer
- •Women who were registered during the unrestricted enrollment period (through 9/23/07) will automatically qualify
- •Women who were registered during the restricted enrollment period (after 9/23/07) will only be considered if needed
- •Women who had histologically confirmed endometrioid endometrial adenocarcinoma regardless of stage or grade
- •Women who have defective DNA mismatch repair and are microsatellite instability positive (MSI+ and MSI-low)
- •Women who consented to allow their specimens and clinical data to be used for future cancer research
- •Women who have sufficient high-quality genomic DNA from tumor available for mutation analysis of ATR
排除标准
- 未提供
结局指标
主要结局
ATR mutation status
时间窗: 1 month
Parametric and non-parametric statistical tests will be performed to evaluate the association between ATR mutation status and demographic and clinical data. Product-limit estimates according to Kaplan-Meier method will be calculated and difference between survival according to ATR mutation status will be assessed using a two sided log rank test. The predictive ability of the final model will be assessed using a concordance index (C-statistic).
Microsatellite instability (MSI)
时间窗: 1 month
次要结局
未报告次要终点