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NCT02136836 Clinical Trial

Investigation of the Proportion of Human Epidermal Growth Factor Receptor 2 Protein Overexpression of Gastric Adenocarcinoma and Prognostic Effect of HER2, and Analysis of Practice Pattern of Herceptin Use in Stage IV Gastric Cancer

Stomach Neoplasms Clinical Trial

— HER2  

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT02136836
Other study ID # GSCH-STO13-01
Secondary ID Roche
Status Active, not recruiting
Phase N/A
First received May 8, 2014
Last updated May 12, 2014
Start date May 2014

Study information
Verified date April 2014
Source Yonsei University
Contact n/a
Is FDA regulated No
Health authority Korea: Institutional Review Board
Study type Observational

Clinical Trial Summary

The objective of this study is to investigate the proportion of HER2 overexpression in gastric cancer patients group, to evaluate the relation of HER2 overexpression with prognosis, and to analyze the proportion of herceptin applied to patients in clinical field. Furthermore, the investigators are going to reevaluate the clinical benefit of Herceptin for survival prolongation compared to chemotherapy only.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 860
Est. completion date
Est. primary completion date March 2015
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

1. Histologically confirmed gastric adenocarcinoma

2. Patients were diagnosed during 2006-2013

3. HER2 expression status was evaluated in primary gastric cancer or metastatic lesion.

Exclusion Criteria:

- Patients with second primary cancer within 5 years

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

Locations
Country Name City State
Korea, Republic of Gangnam Severance Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Other The practice pattern of Herceptin use in stage IV gastric cancer 3 years No
Primary The proportion of HER2 overexpression in gastric cancer patients 8 years No
Secondary Gastric cancer specific survival according to HER2 expression in each stage 5 years No
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