NCT02773784已完成不适用
Comparison of Core Needle Biopsy (CNB) and Surgical Specimens for Estrogen Receptor (ER), Progesterone Receptor (PgR), Human Epidermal Growth Factor Receptor 2 (HER2) Status and Ki67 Index in Invasive Breast Cancer.
Peking University1 个研究点 分布在 1 个国家目标入组 314 人开始时间: 2014年9月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 314
- 试验地点
- 1
- 主要终点
- The accuracy of ER, PgR, Her-2 and Ki67 for core needle biopsy (CNB) using the surgical specimens as reference, respectively.
研究概览
简要总结
- This is a prospective, single-center, non-randomized, non-controlled study.
- The estrogen receptor (ER), progesterone receptor (PgR), HER2 status and Ki67 index of CNB specimen are critical biomarkers for making neoadjuvant therapy strategy in invasive breast cancer. The concordance of these biomarkers between CNB and surgical specimen was varied in previous retrospective reports. The aim of this study is to determine the discordance of these biomarkers between CNB and surgical specimen and the influence of making treatment strategy by the discordance.
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
- •• histologically confirmed primary invasive breast cancer by core needle biopsy
排除标准
- •• pathological diagnosed ductal carcinoma in situ or microinvasive breast cancer by core needle biopsy
- •patient plans to receive neo-adjuvant system therapy
结局指标
主要结局
The accuracy of ER, PgR, Her-2 and Ki67 for core needle biopsy (CNB) using the surgical specimens as reference, respectively.
时间窗: within 4 weeks after obtaining the post-surgery pathological results
The accuracy of ER, PgR, Her-2 and Ki67 for core needle biopsy (CNB) will be assessed by four parameters respectively, which are sensitivity, specificity, the negative predictive values and the positive predictive values, using the surgical specimens as reference.
次要结局
- Discordance of system therapy strategies between using biomarkers of CNB and surgical specimens.(within 4 weeks after obtaining the post-surgery pathological results)
研究者
Tao OUYANG
Director of Breast Center of Peking University Cancer Hospital
Peking University
研究点 (1)
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