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Clinical Trials/NCT04184960
NCT04184960
Recruiting
Not Applicable

Performance of Endoscopic and Histological Criteria of Atrophic Gastritis and Intestinal Metaplasia in Predicting Risk of Gastric Cancer - a Multicenter Case Control Study

Chinese University of Hong Kong4 sites in 4 countries400 target enrollmentDecember 5, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Gastric Cancer
Sponsor
Chinese University of Hong Kong
Enrollment
400
Locations
4
Primary Endpoint
Operative links on gastritis assessment (OLGA)
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

This is a multi-center prospective case control study aiming to compare different methods of risk stratification models in predicting the risk of gastric cancer development.

Detailed Description

The case control study would compare which type of assessment (Endoscopic / histological) is more accurate in predicting the risk of gastric cancer development. The risk factor assessment would be based on the following criteria. Endoscopic assessment: 1. Atrophic gastritis, based on Kimura Takemoto Classification 2. Kyoto classification of gastritis 3. Intestinal metaplasia, based on Endoscopic Mapping and Grading of Intestinal Metaplasia (EGGIM) Histological assessment (Based on random biopsies) 1. Operative Links on Gastritis Assessment 2. Operative Links on Gastric Intestinal Metaplasia

Registry
clinicaltrials.gov
Start Date
December 5, 2019
End Date
March 31, 2024
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Hon Chi Yip

Associate Consultant

Chinese University of Hong Kong

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Operative links on gastritis assessment (OLGA)

Time Frame: Cross sectional study, day 0

Biopsy based risk stratification panel based on severity of atrophic gastritis

Operative links on gastric intestinal metaplasia (OLGIM)

Time Frame: Cross sectional study, day 0

Biopsy based risk stratification panel based on severity of intestinal metaplasia

Endoscopic grading of intestinal metaplasia (EGGIM)

Time Frame: Cross sectional study, day 0

Endoscopic mapping of degree of intestinal metaplasia

Endoscopic grading of atrophic gastritis (Kimura Takemoto Classification)

Time Frame: Cross sectional study, day 0

Endoscopic description of severity of gastric atrophy

Kyoto classification of gastritis

Time Frame: Cross sectional study, day 0

Descriptive findings of gastritis

Study Sites (4)

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