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Completed

NCT Number: NCT02538562

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

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.

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Key information

Conditions

Gastric Cancer Digestive System Diseases Digestive System Neoplasms Gastroesophageal Junction Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Sex eligibility

All sexes

Study type

Observational

Primary location

Dongnam Inst.of Radiological & Medical Sciences, Busan, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Incidence of HER2 positivity among gastric and gastroesophageal junction tumor samples

    Time frame: Up to 12 months of sample collection

Secondary outcomes

  1. Correlation between HER2 status and tumor stage

    Time frame: Up to 12 months of sample collection

  2. Correlation between HER2 status and tumor type

    Time frame: Up to 12 months of sample collection

  3. Correlation between HER2 status and cancer diagnosis

    Time frame: Up to 12 months of sample collection

  4. Correlation between HER2 status and age

    Time frame: Up to 12 months of sample collection

  5. Correlation between HER2 status and gender

    Time frame: Up to 12 months of sample collection

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Sep 2, 2015
Registry last updated
Jul 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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