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
1 other identifier
observational
1,695
1 country
14
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2011
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 11, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 19, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 19, 2013
CompletedFirst Submitted
Initial submission to the registry
August 31, 2015
CompletedFirst Posted
Study publicly available on registry
September 2, 2015
CompletedJuly 11, 2017
July 1, 2017
1.5 years
August 31, 2015
July 6, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of HER2 positivity among gastric and gastroesophageal junction tumor samples
Up to 12 months of sample collection
Secondary Outcomes (5)
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
Study Arms (1)
Study Population
Available tumor samples from patients with gastric or gastroesophageal junction cancer will be analyzed. No study visits or interventions are planned.
Eligibility Criteria
Available tumor samples from patients with gastric or gastroesophageal junction cancer will be analyzed. No study visits or interventions are planned.
You may qualify if:
- 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
You may not qualify if:
- None specified
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
Dongnam Inst.of Radiological & Medical Sciences
Busan, 46033, South Korea
Inje University Busan Paik Hospital
Busan, 47392, South Korea
Inje university Haeundae Paik Hospital
Busan, 48108, South Korea
Kosin University Gospel Hospital
Busan, 49267, South Korea
Pusan University Hospital
Busan, 602-739, South Korea
Samsung Changwon Hospital
Changwon, South Korea
Dankook University Hospital
Chungcheongnam-do, 31116, South Korea
Keimyung University Dongsan Medical Center
Daegu, 41931, South Korea
Daegu Catholic University Medical Center
Daegu, 42472, South Korea
Yeungnam Univ. Hospital
Daegu, 705-717, South Korea
Chosun University Hospital
Gwangju, 61453, South Korea
Pusan National University Yangsan Hospital
Gyeongsangnam-do, 50612, South Korea
Gyeongsang National University Hospital
Gyeongsangnam-do, 52727, South Korea
Chonbuk National Uni Hospital
Jeollabuk-do, 561-712, South Korea
Biospecimen
Approximately 2000 tumor tissue samples will be obtained from 17 local laboratories in Korea. Because the study itself is noninterventional, samples must have been previously collected in accordance with routine clinical practice.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 31, 2015
First Posted
September 2, 2015
Study Start
October 11, 2011
Primary Completion
April 19, 2013
Study Completion
April 19, 2013
Last Updated
July 11, 2017
Record last verified: 2017-07