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

HER2 Advanced Gastric Epidemiology Study in Korea: An Assessment of HER2 Status in Tumor Tissue Samples of Gastric and Gastro-esophageal (GE) Junction Cancer

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02538562

Enrollment

1695

Registered

2015-09-02

Start date

2011-10-11

Completion date

2013-04-19

Last updated

2017-07-11

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

Conditions

Gastric Cancer, Gastroesophageal Junction Cancer

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Exclusion criteria

* None specified

Design outcomes

Primary

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

Secondary

Measure	Time frame
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 cancer diagnosis	Up to 12 months of sample collection
Correlation between HER2 status and age	Up to 12 months of sample collection
Correlation between HER2 status and gender	Up to 12 months of sample collection

Countries

South Korea

Outcome results