Human Epidermal Growth Factor Receptor 2 (HER2) Advanced Gastric Epidemiology Study in Korea

Completed

• Conditions: Gastric Cancer; Gastroesophageal Junction Cancer

• Registration Number: NCT02538562
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

This study is designed to gather epidemiological data in Korea on HER2 incidence in gastric and gastroesophageal junction cancer as assessed by local laboratories in a real-life setting. No investigational products will be provided or evaluated.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10-11
• Primary Completion: 2013-04-19
• Study Completion: 2013-04-19
• Study First Submitted: 2015-08-31
• Study First Submitted QC: 2015-08-31
• Study First Posted: 2015-09-02
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-06
• Last Update Posted: 2017-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1695

Inclusion Criteria

• Formalin-fixed, paraffin-embedded tumor tissue samples with histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction with locally advanced, recurrent, and/or metastatic disease
• Sufficient invasive tumor tissue for HER2 evaluation, including surgical excision specimens or at least 6 to 8 available biopsies

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Exclusion Criteria

• None specified

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of HER2 positivity among gastric and gastroesophageal junction tumor samples	Up to 12 months of sample collection

Secondary Outcome Measures

Name	Time	Method
Correlation between HER2 status and cancer diagnosis	Up to 12 months of sample collection
Correlation between HER2 status and gender	Up to 12 months of sample collection
Correlation between HER2 status and tumor stage	Up to 12 months of sample collection
Correlation between HER2 status and tumor type	Up to 12 months of sample collection
Correlation between HER2 status and age	Up to 12 months of sample collection

Trial Locations

Locations (14)

Chonbuk National Uni Hospital; 🇰🇷 Jeollabuk-do, Korea, Republic of

Inje university Haeundae Paik Hospital; 🇰🇷 Busan, Korea, Republic of

Inje University Busan Paik Hospital; 🇰🇷 Busan, Korea, Republic of

Daegu Catholic University Medical Center; 🇰🇷 Daegu, Korea, Republic of

Gyeongsang National University Hospital; 🇰🇷 Gyeongsangnam-do, Korea, Republic of

Kosin University Gospel Hospital; 🇰🇷 Busan, Korea, Republic of

Pusan University Hospital; 🇰🇷 Busan, Korea, Republic of

Samsung Changwon Hospital; 🇰🇷 Changwon, Korea, Republic of

Dankook University Hospital; 🇰🇷 Chungcheongnam-do, Korea, Republic of

Yeungnam Univ. Hospital; 🇰🇷 Daegu, Korea, Republic of

Dongnam Inst.of Radiological & Medical Sciences; 🇰🇷 Busan, Korea, Republic of

Keimyung University Dongsan Medical Center; 🇰🇷 Daegu, Korea, Republic of

Chosun University Hospital; 🇰🇷 Gwangju, Korea, Republic of

Pusan National University Yangsan Hospital; 🇰🇷 Gyeongsangnam-do, Korea, Republic of