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NCT03380052 Clinical Trial

OLGA and OLGIM Stage System for Gastric Cancer

Stomach Neoplasms Clinical Trial

Official title:
The Evaluation of OLGA and OLGIM Stage Systems for Prediction of Gastric Cancer Risk and Interaction With Other Risk Factors According to Lauren's Classification

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03380052
Other study ID # B-1610/368-106
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 2006
Est. completion date January 2022

Study information
Verified date April 2023
Source Seoul National University Bundang Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To validate OLGA and OLGIM staging system with serum pepsinogen for estimating GC risk according to Lauren's histologic classification in South Korea. Also attempted to estimate synergistic interaction among the several risk factors to help establish surveillance strategy.

Description:

To validated the OLGA and OLGIM staging system with serum pepsinogen to estimate gastric cancer risk according to Lauren's histologic classification in South Korea, where the incidence rate of GC is high. In addition, the investigators attempted to investigate the interaction among the several risk factors including OLGA or OLGIM staging system for the risk of GC to help establish surveillance strategy.

Recruitment information / eligibility
Status Completed
Enrollment 2900
Est. completion date January 2022
Est. primary completion date January 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 25 Years to 80 Years
Eligibility Inclusion Criteria: - Control group - those who were between 25 and 80 years old and did not have any evidence of gastric cancer and gastric dysplasia, esophageal tumor and MALToma in upper gastrointestinal endoscopy - Gastric cancer group - Patients diagnosed as gastric cancer in the upper gastrointestinal endoscopy at the time of participating in the study between 25 and 80 years old. Exclusion Criteria: - history of previous gastrointestinal surgery, - any other malignancy - cardia cancer - who do not perform endoscopic biopsy - pathologically proven gastric dysplasia

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Korea, Republic of Seoul National University Bundang Hospital Seongnam-si Gyeonggi-do

Sponsors (2)
Lead Sponsor Collaborator
Seoul National University Bundang Hospital National Clinical Research Coordination Center, Seoul, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary The evaluation of OLGA and OLGIM stage systems with serum pepsinogen for prediction of gastric cancer risk To validate OLGA and OLGIM staging system with serum pepsinogen for estimating GC risk according to Lauren's histologic classification per 1 year
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