Gastric Cancer Screening Quality Improvement System Establishment

April 14, 2016 updated by: Su Jin Chung, Seoul National University Hospital

A Prospective Cohort Study for Development of Korean Gastric Cancer Prediction Model and Tailored Gastric Cancer Screening Program

Experienced endoscopists will perform endoscopy during the study period and the detection rate of gastric premalignant lesion, correlation between endoscopic and serologic diagnosis of premalignant lesions and inter-observer agreement rate will be analyzed before and after the education.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This study is an extension of quality assurance program in Seoul National University Hospital Healthcare System Gangnam Center. This study is composed of four periods. First, the detection rate of gastric premalignant lesions and the correlation between endoscopic and serologic diagnosis of premalignant lesions will be analyzed retrospectively from March 2008 till February 2009 and from March 2013 till February 2014, when the levels of serum pepsinogen were achieved from the patients. In the second period from March 2015 till April 2015, quality assurance program will be activated. Endoscopists will be educated on the Kimura-Takemoto classification for chronic atrophic gastritis. After that their diagnosis will be tested and they will have feedback and discussion all together. In this period, inter-observer agreement rate will be assessed serially. Third, prospective trial will run from May 2015 till April 2020, in which all the endoscopists' detection rate of gastric premalignant lesion, the correlation between endoscopic and serologic diagnosis of premalignant lesions, and their inter-observer agreement will be analyzed. Finally, cumulative incidence and mortality rate of gastric cancer and incidence rate of gastric dysplasia will be investigated until December 2020.

Study Type

Observational

Enrollment (Anticipated)

17

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Recruiting
        • Healthcare System Gangnam Center, Seoul National University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who received colonoscopy in Seoul National University Hospital Healthcare System Gangnam Center from 2008 till 2020.

Description

Inclusion Criteria:

  • Patients who received endoscopy in Seoul National University Hospital Healthcare System Gangnam Center from 2008 till 2020.

Exclusion Criteria:

  • Age < 18 years
  • Those who refused to be included in the research
  • History of gastric cancer
  • Current medication with proton pump inhibitor, non-steroidal anti-inflammatory drug or aspirin
  • Active/healing stage of gastric ulcer or gastric ulcer scar
  • Active/healing stage of duodenal ulcer
  • History of previous surgical or endoscopic resection of stomach

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Experienced endoscopists
All the experienced endoscopists will receive education and feedback on the diagnosis for premalignant lesion of chronic atrophic gastritis and intestinal metaplasia
Behavioral: Education and feedback
Experienced endoscopists will receive education on Kimura-Takemoto classification and feedback for their answers for classification tests.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Detection rate for gastric premalignant lesion
Time Frame: 7 years
7 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Correlation between endoscopic and serologic diagnosis of premalignant lesions
Time Frame: 7 years
7 years
Inter-observer agreement rate for the diagnosis of premalignant lesions
Time Frame: 2 months
2 months
Detection rate for gastric cancer
Time Frame: 7 years
7 years
Detection rate for gastric dysplasia
Time Frame: 7 years
7 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Su Jin Chung, MD.PhD., Department of Internal Medicine and Healthcare Research Institute, Healthcare System Gangnam Center, Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (ANTICIPATED)

April 1, 2020

Study Completion (ANTICIPATED)

December 1, 2020

Study Registration Dates

First Submitted

March 25, 2015

First Submitted That Met QC Criteria

May 26, 2015

First Posted (ESTIMATE)

May 29, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

April 18, 2016

Last Update Submitted That Met QC Criteria

April 14, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1503-044-655

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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