NCT03380052

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,900

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
11.9 years until next milestone

First Submitted

Initial submission to the registry

December 16, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 20, 2017

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

April 13, 2023

Status Verified

April 1, 2023

Enrollment Period

14.9 years

First QC Date

December 16, 2017

Last Update Submit

April 12, 2023

Conditions

Keywords

OLGAOLGIMHelicobacter pyloriGastric cancerpepsinogen

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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

Eligibility Criteria

Age25 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • history of previous gastrointestinal surgery,
  • any other malignancy
  • cardia cancer
  • who do not perform endoscopic biopsy
  • pathologically proven gastric dysplasia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

MeSH Terms

Conditions

Stomach NeoplasmsGastritis, Atrophic

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach DiseasesGastritisGastroenteritis

Study Officials

  • Officials Officials, Officials

    Seoul National University Bundang Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 16, 2017

First Posted

December 20, 2017

Study Start

February 1, 2006

Primary Completion

January 1, 2021

Study Completion

January 1, 2022

Last Updated

April 13, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations