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

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02538562
• Other study ID #: ML25697
• Status: Completed
• Phase: N/A
• First received: August 31, 2015
• Last updated: July 6, 2017
• Start date: October 11, 2011
• Est. completion date: April 19, 2013

Study information

• Verified date: July 2017
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1695
• Est. completion date: April 19, 2013
• Est. primary completion date: April 19, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Gastric Cancer
• Gastroesophageal Junction Cancer
• Stomach Neoplasms

Locations

Country	Name	City	State
Korea, Republic of	Dongnam Inst.of Radiological & Medical Sciences	Busan
Korea, Republic of	Inje University Busan Paik Hospital	Busan
Korea, Republic of	Inje university Haeundae Paik Hospital	Busan
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	Daegu Catholic University Medical Center	Daegu
Korea, Republic of	Keimyung University Dongsan Medical Center	Daegu
Korea, Republic of	Yeungnam Univ. Hospital	Daegu
Korea, Republic of	Chosun University Hospital	Gwangju
Korea, Republic of	Gyeongsang National University Hospital	Gyeongsangnam-do
Korea, Republic of	Pusan National University Yangsan Hospital	Gyeongsangnam-do
Korea, Republic of	Chonbuk National Uni Hospital	Jeollabuk-do

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of HER2 positivity among gastric and gastroesophageal junction tumor samples		Up to 12 months of sample collection
Secondary	Correlation between HER2 status and tumor stage		Up to 12 months of sample collection
Secondary	Correlation between HER2 status and tumor type		Up to 12 months of sample collection
Secondary	Correlation between HER2 status and cancer diagnosis		Up to 12 months of sample collection
Secondary	Correlation between HER2 status and age		Up to 12 months of sample collection
Secondary	Correlation between HER2 status and gender		Up to 12 months of sample collection