The Clinical Study of Assessing HER-2 Expression in Gastric Cancer With Extra Tumor Tissue Paraffin Blocks Using Immunohistochemistry
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|ClinicalTrials.gov Identifier: NCT02843412|
Recruitment Status : Unknown
Verified July 2016 by Shanghai Zhongshan Hospital.
Recruitment status was: Not yet recruiting
First Posted : July 25, 2016
Last Update Posted : July 25, 2016
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.
|Condition or disease||Intervention/treatment|
|Gastric Cancer Surgical Specimens,18-80 Years Old, at Least Two Tumor Tissue Blocks||Procedure: choose two tumor tissue paraffin blocks|
|Study Type :||Observational|
|Estimated Enrollment :||2000 participants|
|Study Start Date :||August 2016|
|Estimated Primary Completion Date :||May 2018|
choose one tumor tissue paraffin blocks
choose two tumor tissue paraffin blocks
Procedure: choose two tumor tissue paraffin blocks
- compare the positive rate [ Time Frame: 3 years ]