NCT03841266已完成不适用
Postoperative Recurrence Risk Evaluation of Hormone Receptor Positive, Her-2 Negative Breast Cancer by Using Different 21-gene Detection Kits (REBCK)
Xijing Hospital1 个研究点 分布在 1 个国家目标入组 220 人开始时间: 2019年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- correlation analysis
研究概览
简要总结
Breast cancer patients with early breast cancer were enrolled according to the inclusion criteria. Baseline characteristics were recorded from medical record system. Recurrence score were obtained by 21-gene detection kits from different biological companies. Relationship between recurrence score and the prognosis was explored. Meanwhile, the investigators analyzed the consistency of the results obtained from various 21-gene test kits and immunohistochemistry detection.
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 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •breast cancer in stage I-III, tumor size>0.5cm
- •lymph nodes negative
- •hormone receptor positive （ER+/PR+,ER+/PR-,ER-/PR+）
- •HER2 negative（IHC 0 or +， FISH negative）
- •receive endocrine therapy only
- •enough FFPE samples within 10 years（3~6 10μm ）
- •patients with integrated medical records
排除标准
- •Tumor cells <5%
- •Isolated RNA<500ng
结局指标
主要结局
correlation analysis
时间窗: Janyary 1, 2019-December 31, 2019
x2 value and P value of chi-square test
次要结局
- consistency analysis(Janyary 1, 2019-December 31, 2019)
研究者
LiNanlin,Ph.D, Chief Physician,Clinical Professor
Professor, Thyroid breast and vascular surgery, Principal Investigator
Xijing Hospital
研究点 (1)
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