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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02843412
Enrollment
2000
Registered
2016-07-25
Start date
2016-08-31
Completion date
Unknown
Last updated
2016-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Gastric cancer, Her2/neu, Dual paraffin blocks, Trastuzumab, Clinical Prospective Multicenter Cohort Study

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.

Interventions

PROCEDUREchoose two tumor tissue paraffin blocks

Sponsors

Shanghai Zhongshan Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frame
compare the positive rate3 years

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026