Gastric Cancer Screening Quality Improvement System Establishment

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02457624
• Other study ID #: 1503-044-655
• Status: Recruiting
• Phase: N/A
• First received: March 25, 2015
• Last updated: May 26, 2015
• Start date: March 2008
• Est. completion date: December 2020

Study information

• Verified date: May 2015
• Source: Seoul National University Hospital
• Contact: Joo Hyun Lim, MD.
• Phone: +82-02-2112-5807
• Email: limz00[@]gmail.com
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 17
• Est. completion date: December 2020
• Est. primary completion date: April 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Gastric Cancer
• Gastritis
• Gastritis, Atrophic
• Intestinal Metaplasia
• Metaplasia
• Stomach Neoplasms

Intervention

Behavioral:
• Education and feedback
Experienced endoscopists will receive education on Kimura-Takemoto classification and feedback for their answers for classification tests.

Locations

Country	Name	City	State
Korea, Republic of	Healthcare System Gangnam Center, Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection rate for gastric premalignant lesion		7 years	No
Secondary	Correlation between endoscopic and serologic diagnosis of premalignant lesions		7 years	No
Secondary	Inter-observer agreement rate for the diagnosis of premalignant lesions		2 months	No
Secondary	Detection rate for gastric cancer		7 years	No
Secondary	Detection rate for gastric dysplasia		7 years	No