Prognostic significance of HER2 expression in patients with resectable gastric cancer

ISRCTN	ISRCTN54802594
DOI	https://doi.org/10.1186/ISRCTN54802594
Secondary identifying numbers	N/A

Submission date: 23/08/2018
Registration date: 11/09/2018
Last edited: 11/09/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

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

Contact information

Prof KwangHee Kim
Public

Bokji-ro 75, Busangjin-gu
Busan
47392
Korea, South

Study information

Study design	Observational cohort study
Primary study design	Observational
Secondary study design	Cohort study
Study setting(s)	Hospital
Study type	Treatment
Scientific title	Prognostic significance of HER2 expression in patients with resectable gastric adenocarcinoma
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
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

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	782
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 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

Inje University Busan Paik Hospital
Hospital/treatment centre

Bokji-ro 75, Busangjin-gu
Busan
47392
Korea, South

Phone	+82 (0)518906114
Email	inwoodog@naver.com
Website	http://www.paik.ac.kr/busan/
"ROR"	https://ror.org/01pzf6r50

Funders

Funder type

Other

Investigator initiated and funded

No information available

Results and Publications

Intention to publish date	31/12/2018
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	Planned publication in a high-impact peer reviewed journal.
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.