The Clinical Study of Assessing HER-2 Expression in Gastric Cancer With Extra Tumor Tissue Paraffin Blocks Using Immunohistochemistry
- Conditions
- Gastric Cancer Surgical Specimens,18-80 Years Old, at Least Two Tumor Tissue Blocks
- Interventions
- Procedure: choose two tumor tissue paraffin blocks
- Registration Number
- NCT02843412
- Lead Sponsor
- Shanghai Zhongshan Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 2000
- Undergone curative surgery of gastric cancer,
- 18-80 years old.
- None
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description group 2 choose two tumor tissue paraffin blocks choose two tumor tissue paraffin blocks
- Primary Outcome Measures
Name Time Method compare the positive rate 3 years
- Secondary Outcome Measures
Name Time Method