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

NCT ID: NCT02538562

Last Updated: 2017-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1695 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-10-11

Study Completion Date

2013-04-19

Brief Summary

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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.

Detailed Description

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Conditions

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Gastric Cancer Gastroesophageal Junction Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Study Population

Available tumor samples from patients with gastric or gastroesophageal junction cancer will be analyzed. No study visits or interventions are planned.

No interventions assigned to this group

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Dongnam Inst.of Radiological & Medical Sciences

Busan, , South Korea

Site Status

Inje University Busan Paik Hospital

Busan, , South Korea

Site Status

Inje university Haeundae Paik Hospital

Busan, , South Korea

Site Status

Kosin University Gospel Hospital

Busan, , South Korea

Site Status

Pusan University Hospital

Busan, , South Korea

Site Status

Samsung Changwon Hospital

Changwon, , South Korea

Site Status

Dankook University Hospital

Chungcheongnam-do, , South Korea

Site Status

Keimyung University Dongsan Medical Center

Daegu, , South Korea

Site Status

Daegu Catholic University Medical Center

Daegu, , South Korea

Site Status

Yeungnam Univ. Hospital

Daegu, , South Korea

Site Status

Chosun University Hospital

Gwangju, , South Korea

Site Status

Pusan National University Yangsan Hospital

Gyeongsangnam-do, , South Korea

Site Status

Gyeongsang National University Hospital

Gyeongsangnam-do, , South Korea

Site Status

Chonbuk National Uni Hospital

Jeollabuk-do, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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ML25697

Identifier Type: -

Identifier Source: org_study_id

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