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

Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Completed
CT.gov ID
NCT02538562
Collaborator
(none)
1,695
Enrollment
14
Locations
18.3
Actual Duration (Months)
121.1
Patients Per Site
6.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    1695 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    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
    Actual Study Start Date :
    Oct 11, 2011
    Actual Primary Completion Date :
    Apr 19, 2013
    Actual Study Completion Date :
    Apr 19, 2013

    Arms and Interventions

    Arm Intervention/Treatment
    Study Population

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

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of HER2 positivity among gastric and gastroesophageal junction tumor samples [Up to 12 months of sample collection]

    Secondary Outcome Measures

    1. Correlation between HER2 status and tumor stage [Up to 12 months of sample collection]

    2. Correlation between HER2 status and tumor type [Up to 12 months of sample collection]

    3. Correlation between HER2 status and cancer diagnosis [Up to 12 months of sample collection]

    4. Correlation between HER2 status and age [Up to 12 months of sample collection]

    5. Correlation between HER2 status and gender [Up to 12 months of sample collection]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Dongnam Inst.of Radiological & Medical Sciences Busan Korea, Republic of 46033
    2 Inje University Busan Paik Hospital Busan Korea, Republic of 47392
    3 Inje university Haeundae Paik Hospital Busan Korea, Republic of 48108
    4 Kosin University Gospel Hospital Busan Korea, Republic of 49267
    5 Pusan University Hospital Busan Korea, Republic of 602-739
    6 Samsung Changwon Hospital Changwon Korea, Republic of
    7 Dankook University Hospital Chungcheongnam-do Korea, Republic of 31116
    8 Keimyung University Dongsan Medical Center Daegu Korea, Republic of 41931
    9 Daegu Catholic University Medical Center Daegu Korea, Republic of 42472
    10 Yeungnam Univ. Hospital Daegu Korea, Republic of 705-717
    11 Chosun University Hospital Gwangju Korea, Republic of 61453
    12 Pusan National University Yangsan Hospital Gyeongsangnam-do Korea, Republic of 50612
    13 Gyeongsang National University Hospital Gyeongsangnam-do Korea, Republic of 52727
    14 Chonbuk National Uni Hospital Jeollabuk-do Korea, Republic of 561-712

    Sponsors and Collaborators

    • Hoffmann-La Roche

    Investigators

    • Study Director: Clinical Trials, Hoffmann-La Roche

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hoffmann-La Roche
    ClinicalTrials.gov Identifier:
    NCT02538562
    Other Study ID Numbers:
    • ML25697
    First Posted:
    Sep 2, 2015
    Last Update Posted:
    Jul 11, 2017
    Last Verified:
    Jul 1, 2017
    Additional relevant MeSH terms:
    Stomach Neoplasms

    Study Results

    No Results Posted as of Jul 11, 2017