Ignite Creation Date:
2024-05-06 @ 8:53 AM
Last Modification Date:
2024-10-26 @ 12:06 PM
Study NCT ID:
NCT02843412
Status:
UNKNOWN
Last Update Posted:
2016-07-25
First Post:
2016-07-21
Brief Title:
The Clinical Study of Assessing HER-2 Expression in Gastric Cancer With Extra Tumor Tissue Paraffin Blocks Using Immunohistochemistry
Sponsor:
Shanghai Zhongshan Hospital
Organization:
Shanghai Zhongshan Hospital
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2016-07
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background Gastric cancer GC is major global health concern and the second leading cause of cancer deaths worldwide Amplification of Her2neu gene andor overexpression of the Her2neu protein have been observed in GC Trastuzumab Herceptin is an anti-Her2neu antibody which has been successfully applied in GC However the intratumoral heterogeneity of Her2neu overexpression and amplification in GC should be noticed The investigators investigated the significance of evaluating Her2neu 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 n1000 and a cohort using dual tumor tissue paraffin blocks cohort 2 n1000 when evaluating Her2neu 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
Methods 2000 GC patients from ten centers patients were divided into a cohort using one tumor tissue paraffin block cohort 1 n1000 and a cohort using dual tumor tissue paraffin blocks cohort 2 n1000 when evaluating Her2neu 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None