The Clinical Study of Assessing HER-2 Expression in Gastric Cancer With Extra Tumor Tissue Paraffin Blocks Using Immunohistochemistry

NCT ID: NCT02843412

Last Updated: 2016-07-25

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 2000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-08-31

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.

Conditions

Gastric Cancer Surgical Specimens,18-80 Years Old, at Least Two Tumor Tissue Blocks

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

group 1

choose one tumor tissue paraffin blocks

No interventions assigned to this group

group 2

choose two tumor tissue paraffin blocks

choose two tumor tissue paraffin blocks

Intervention Type: PROCEDURE

Interventions

choose two tumor tissue paraffin blocks

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Undergone curative surgery of gastric cancer,
• 18-80 years old.

Exclusion Criteria

• None

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Zhongshan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

Xu C, Sun M, Jin M, Li Z, Qin R, Ren G, Sun W, Chen L, Luan L, Liu Y, Jiang D, Chen L, Luo R, Hou Y. Dual block HER2 assessment increased HER2 immunohistochemistry positive rate in resected specimens of gastric cancer: a prospective multicenter clinical trial from China. Diagn Pathol. 2022 Jun 28;17(1):54. doi: 10.1186/s13000-022-01230-7.

Reference Type: DERIVED

PMID: 35765007 (View on PubMed)

Other Identifiers

123

Identifier Type: -

Identifier Source: org_study_id