NCT02538562CompletedNot Applicable
HER2 Advanced Gastric Epidemiology Study in Korea: An Assessment of HER2 Status in Tumor Tissue Samples of Gastric and Gastro-esophageal (GE) Junction Cancer
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 1,695
- Locations
- 14
- Primary Endpoint
- Incidence of HER2 positivity among gastric and gastroesophageal junction tumor samples
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Incidence of HER2 positivity among gastric and gastroesophageal junction tumor samples
Time Frame: Up to 12 months of sample collection
Secondary Outcomes
- 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)
- 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)
Investigators
Study Sites (14)
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