OLGA and OLGIM Stage System for Gastric Cancer

April 12, 2023 updated by: Nayoung Kim, Seoul National University Bundang Hospital

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

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.

Study Overview

Status

Completed

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Actual)

2900

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
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
        • Seoul National University Bundang Hospital

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

25 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Patients who visited gastroenterology department complaining of gastrointestinal symptoms and underwent esophagogastroduodenoscopy (EGD)

Description

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 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

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Gastric cancer
Patients who were diagnosed with gastric cancer
Control
Healthy participants or benign disease patients such as benign gastric ulcers, duodenal ulcers, reflux esophagitis, or non-erosive reflux disease

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

Seoul National University Bundang Hospital

Collaborators

National Clinical Research Coordination Center, Seoul, Korea

Investigators

  • Principal Investigator: Officials Officials, Officials, Seoul National University Bundang 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 (Actual)

February 1, 2006

Primary Completion (Actual)

January 1, 2021

Study Completion (Actual)

January 1, 2022

Study Registration Dates

First Submitted

December 16, 2017

First Submitted That Met QC Criteria

December 16, 2017

First Posted (Actual)

December 20, 2017

Study Record Updates

Last Update Posted (Estimate)

April 13, 2023

Last Update Submitted That Met QC Criteria

April 12, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B-1610/368-106

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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