Condition category
Cancer
Date applied
23/08/2018
Date assigned
11/09/2018
Last edited
11/09/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results overdue

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

Trial website

Contact information

Type

Public

Primary contact

Prof KwangHee Kim

ORCID ID

Contact details

Bokji-ro 75
Busangjin-gu
Busan
47392
Korea
South

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

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

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

Trial setting

Hospitals

Trial 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

Phase

Drug names

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 trial start date

01/03/2017

Overall trial 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

Patient

Age group

Adult

Gender

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

Trial 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

http://www.paik.ac.kr/busan/

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.

IPD sharing statement
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.

Intention to publish date

31/12/2018

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes