Plain English Summary
Background and study aims
The aim of this study is to investigate the relationship between human epidermal growth factor receptor 2 (HER2) overexpression and clinicopathologic factors and survival rate in patients who underwent curative gastrectomy (removal of part or all of the stomach) as treatment for gastric adenocarcinoma (stomach cancer).
Who can participate?
Patients who underwent curative gastrectomy to treat gastric adenocarcinoma at Inje University Paik Hospital over four years, from January 2012 to December 2015
What does the study involve?
HER2 expression levels measured and clinicopathologic records are collected from a gastric cancer database to identify clinicopathologic features and survival rates of the patients.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Inje University Busan Paik Hospital (China)
When is the study starting and how long is it expected to run for?
March 2017 to January 2018
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Prof. Kwang-Hee Kim
Study website
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Secondary identifying numbers
N/A
Study information
Scientific title
Prognostic significance of HER2 expression in patients with resectable gastric adenocarcinoma
Acronym
Study hypothesis
The purpose of this study was to investigate HER2 overexpression by immunohistochemical (IHC) analysis in gastric adenocarcinoma tissues that were obtained by curative gastrectomy. In addition, the trialists compared clinicopathologic factors and survival rates according to HER2 expression level to identify factors associated with HER2 overexpression. Furthermore, HER2 overexpression was examined to determine its value as an independent prognostic factor.
Ethics approval(s)
Institutional Review Board at the Inje University Busan Paik Hospital, 24/07/2017, IRB No. 17-0104
Study design
Observational cohort study
Primary study design
Observational
Secondary study design
Cohort study
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
Condition
Gastric adenocarcinoma
Intervention
Among patients who underwent curative gastrectomy to treat gastric adenocarcinoma at Inje University Paik Hospital over four years, from January 2012 to December 2015, 782 patients underwent an immunohistochemical analysis to evaluate HER2 expression levels. Clinicopathologic records that were collected from a gastric cancer database were retrospectively reviewed to identify clinicopathologic features and survival rates of the patients.
Intervention type
Genetic
Primary outcome measure
HER2 overexpression measured by immunohistochemical (IHC) analysis in gastric adenocarcinoma tissues obtained by curative gastrectomy at baseline
Secondary outcome measures
Clinicopathologic factors and survival rates collected from a gastric cancer database at August 2017
Overall study start date
01/03/2017
Overall study end date
30/01/2018
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Among 810 patients who underwent curative gastrectomy to treat gastric adenocarcinoma at Inje University Busan Paik Hospital over four years, from January 2012 to December 2015, this study included 782 patients after excluding 28 patients who did not undergo IHC analysis
Participant type(s)
Patient
Age group
Adult
Sex
Both
Target number of participants
782
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
01/01/2012
Recruitment end date
31/12/2015
Locations
Countries of recruitment
Korea, South
Study participating centre
Inje University Busan Paik Hospital
Bokji-ro 75, Busangjin-gu
Busan
47392
Korea, South
Sponsor information
Organisation
Inje University Busan Paik Hospital
Sponsor details
Bokji-ro 75
Busangjin-gu
Busan
47392
Korea
South
+82 (0)518906114
inwoodog@naver.com
Sponsor type
Hospital/treatment centre
Website
ROR
Funders
Funder type
Other
Funder name
Investigator initiated and funded
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer reviewed journal.
Intention to publish date
31/12/2018
Individual participant data (IPD) Intention to share
Yes
IPD sharing plan
The datasets generated during and/or analysed during the current study are/will be available upon request from Prof. Kwang-Hee Kim. Surgeons perform gastricectomy and collect personal data. Then, if necessary, manually extract and use the data. So when you ask for data, it is possible to verify that the patient is not identified. The individual has all the data but there is no formalized program. Data is stored on a personal computer. It may be disclosed on demand. However, it is not considered easy to use the data as it is not intended to identify the patient.
IPD sharing plan summary
Available on request
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|