Clinical trial NCT02538562: Human Epidermal Growth Factor Receptor 2 (HER2) Advanced Gastric Epidemiology Study in Korea
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric Cancer
Gastroesophageal Junction Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2015-09-02
Enrollment: 1695
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Available tumor samples from patients with gastric or gastroesophageal junction cancer will be analyzed. No study visits or interventions are planned.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of HER2 positivity among gastric and gastroesophageal junction tumor samples
timeFrame: Up to 12 months of sample collection
Secondary outcomes:
measure: Correlation between HER2 status and tumor stage
timeFrame: Up to 12 months of sample collection
measure: Correlation between HER2 status and tumor type
timeFrame: Up to 12 months of sample collection
measure: Correlation between HER2 status and cancer diagnosis
timeFrame: Up to 12 months of sample collection
measure: Correlation between HER2 status and age
timeFrame: Up to 12 months of sample collection
measure: Correlation between HER2 status and gender
timeFrame: Up to 12 months of sample collection
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Dongnam Inst.of Radiological & Medical Sciences
city: Busan
country: Korea, Republic of
facility: Inje University Busan Paik Hospital
city: Busan
country: Korea, Republic of
facility: Inje university Haeundae Paik Hospital
city: Busan
country: Korea, Republic of
facility: Kosin University Gospel Hospital
city: Busan
country: Korea, Republic of
facility: Pusan University Hospital
city: Changwon
country: Korea, Republic of
facility: Samsung Changwon Hospital
city: Chungcheongnam-do
country: Korea, Republic of
facility: Dankook University Hospital
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
city: Daegu
country: Korea, Republic of
facility: Daegu Catholic University Medical Center
city: Daegu
country: Korea, Republic of
facility: Yeungnam Univ. Hospital
city: Gwangju
country: Korea, Republic of
facility: Chosun University Hospital
city: Gyeongsangnam-do
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
city: Gyeongsangnam-do
country: Korea, Republic of
facility: Gyeongsang National University Hospital
city: Jeollabuk-do
country: Korea, Republic of
facility: Chonbuk National Uni Hospital
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: