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临床试验/NCT02538562
NCT02538562已完成不适用

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

Hoffmann-La Roche14 个研究点 分布在 1 个国家目标入组 1,695 人开始时间: 2011年10月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,695
试验地点
14
主要终点
Incidence of HER2 positivity among gastric and gastroesophageal junction tumor samples

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • None specified

结局指标

主要结局

Incidence of HER2 positivity among gastric and gastroesophageal junction tumor samples

时间窗: Up to 12 months of sample collection

次要结局

  • 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)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (14)

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