AG & IM in CA Stomach Protocol

Recruiting

• Conditions: Gastric Cancer; Atrophic Gastritis; Intestinal Metaplasia
• Interventions: Diagnostic Test: Gastroscopy and gastric biopsies

• Registration Number: NCT04184960
• Lead Sponsor: Chinese University of Hong Kong

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

Study Timeline

• Study First Submitted: 2019-12-01
• Study First Submitted QC: 2019-12-01
• Study First Posted: 2019-12-04
• Study Start: 2019-12-05
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-06
• Last Update Posted: 2023-09-07
• Primary Completion: 2024-01-31
• Study Completion: 2024-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Gastric cancer cohort	Gastroscopy and gastric biopsies	Cohort of patients with gastric cancer
Non-gastric cancer cohort	Gastroscopy and gastric biopsies	Cohort of patients without gastric cancer

Primary Outcome Measures

Name	Time	Method
Operative links on gastritis assessment (OLGA)	Cross sectional study, day 0	Biopsy based risk stratification panel based on severity of atrophic gastritis
Operative links on gastric intestinal metaplasia (OLGIM)	Cross sectional study, day 0	Biopsy based risk stratification panel based on severity of intestinal metaplasia
Endoscopic grading of intestinal metaplasia (EGGIM)	Cross sectional study, day 0	Endoscopic mapping of degree of intestinal metaplasia
Endoscopic grading of atrophic gastritis (Kimura Takemoto Classification)	Cross sectional study, day 0	Endoscopic description of severity of gastric atrophy
Kyoto classification of gastritis	Cross sectional study, day 0	Descriptive findings of gastritis

Trial Locations

Locations (4)

Prince of Wales Hospital; 🇭🇰 Hong Kong, Hong Kong

Osaka International Cancer Institute; 🇯🇵 Osaka, Japan

King Chulalongkorn Memorial Hospital and Chulalongkorn University; 🇹🇭 Bangkok, Thailand

Changi General Hospital; 🇸🇬 Singapore, Singapore