AG & IM in CA Stomach Protocol

Study Overview
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Brief Summary
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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
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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: Atrophic gastritis, based on Kimura Takemoto Classification Kyoto classification of gastritis 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

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

Conditions
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Gastric Cancer, Atrophic Gastritis, Intestinal Metaplasia

Intervention / Treatment
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* Diagnostic Test: Gastroscopy and gastric biopsies


Participation Criteria
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Eligibility Criteria
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Two groups of patients would be recruited in this case control study. Gastric neoplasia group Patients with newly diagnosed or history of cancer of stomach or gastric high grade dysplasia. Control group Patients with no prior history of gastric dysplasia or cancer Inclusion criteria: Age 40 or above Undergo elective upper gastrointestinal endoscopy Exclusion criteria: Patients with history of gastrectomy Patients with severe thrombocytopenia (Platelet count <50) or coagulopathy (INR > 1.5 or on anticoagulation) Contraindication to upper gastrointestinal endoscopy Allergy towards sedative agents (Midazolam / Diazepam) or local anaesthetic spray (Lignocaine) Patients who cannot give informed consent

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Gastric cancer cohort<br>Cohort of patients with gastric cancer | Diagnostic Test: Gastroscopy and gastric biopsies<br>* 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<br>|
| Non-gastric cancer cohort<br>Cohort of patients without gastric cancer | Diagnostic Test: Gastroscopy and gastric biopsies<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastric cancer, Gastroscopy, Atrophic gastritis, Intestinal metaplasia