The Clinical Study of Assessing HER-2 Expression in Gastric Cancer With Extra Tumor Tissue Paraffin Blocks Using Immunohistochemistry
Background: Gastric cancer (GC) is major global health concern and the second leading cause of cancer deaths worldwide. Amplification of Her2/neu gene and/or overexpression of the Her2/neu protein have been observed in GC. Trastuzumab (Herceptin™) is an anti-Her2/neu antibody, which has been successfully applied in GC. However, the intratumoral heterogeneity of Her2/neu overexpression and amplification in GC should be noticed. The investigators investigated the significance of evaluating Her2/neu expression in different paraffin blocks of tumor tissue in GC.
Methods: 2000 GC patients from ten centers, patients were divided into a cohort using one tumor tissue paraffin block (cohort 1, n=1000) and a cohort using dual tumor tissue paraffin blocks (cohort 2, n=1000) when evaluating Her2/neu expression status by immunohistochemistry (IHC). In cohort 2, the investigators combined the results from two different paraffin blocks and used the higher one as the final score.
研究概览
地位
研究类型
注册 (预期的)
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Undergone curative surgery of gastric cancer,
- 18-80 years old.
Exclusion Criteria:
- None
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
干预/治疗 |
---|---|
group 1
choose one tumor tissue paraffin blocks
|
|
group 2
choose two tumor tissue paraffin blocks
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
compare the positive rate
大体时间:3 years
|
3 years
|
合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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