NCT04184960

AG & IM in CA Stomach Protocol

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 400 (estimated)
• Sponsor: Chinese University of Hong Kong · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Accepted

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

Conditions

• Gastric Cancer
• Atrophic Gastritis
• Intestinal Metaplasia

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Gastroscopy and gastric biopsies	Gastroscopy would be performed to assess the degree of atrophic gastritis and intestinal metaplasia. In addition, four random biopsies would be taken in the stomach for histological assessment of AG and IM

Timeline

• Start date: 2019-12-05
• Primary completion: 2024-01-31
• Completion: 2024-03-31
• First posted: 2019-12-04
• Last updated: 2023-09-07

Locations

4 sites across 4 countries: Hong Kong, Japan, Singapore, Thailand