Helicobacter Pylori, Atrophic Gastritis and Intestinal Metaplasia Registry and Prospective Study

Study Overview
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Brief Summary
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Since much is unknown about factors that lead to progression of the pre-neoplastic lesions and cancer. In addition, there is ongoing debate on the optimal surveillance intervals and techniques. To solve these important clinical questions, the establishment of a registry for a longitudinal study is planned.

Detailed Description
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Helicobacter pylori is believed to affect more than half of the world's population and is thought to affect nearly 2 million people in Hong Kong alone. It is a major cause of peptic ulcer disease and is implicated in the pathogenesis of the majority of gastric cancers. Since 1994, the World Health Organization has designated H. pylori infection as a class 1 carcinogen. Gastric cancer was the sixth commonest malignancy in Hong Kong in 2015; it was also the second commonest cause of death from cancer in Asia. It is thought that chronic inflammation of the gastric mucosa caused by H. pylori progresses to pre-neoplastic lesions, namely atrophic gastritis and intestinal metaplasia, before developing into frank dysplasia and carcinoma. Successful H. pylori eradication can lead to a rapid decrease in active inflammation, with early treatment effective in preventing the progression of disease. It is believed that atrophic gastritis may be reversible, whereas intestinal metaplasia has passed the point of no return and unlikely to have regression. National screening programmes in both Japan and Korea recommend endoscopy for all men and women over 40 years of age with several uncontrolled trials suggesting that this has led to a reduction of mortality due to gastric cancer. However, in countries with a lower incidence of gastric cancer, this population-based approach may not be cost-effective. Much is unknown about factors that lead to progression of the pre-neoplastic lesions and cancer. In addition, there is ongoing debate on the optimal surveillance intervals and techniques. To solve these important clinical questions, the establishment of a registry for a longitudinal study is planned.

Official Title
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Helicobacter Pylori, Atrophic Gastritis and Intestinal Metaplasia Registry and Prospective Study

Conditions
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Helicobacter Pylori, Atrophic Gastritis, Intestinal Metaplasia

Intervention / Treatment
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* Diagnostic Test: Esophagogastroduodenoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults >= 18 years of age Written informed consent obtained Diagnosed with current or past H. pylori infection, Histologically proven atrophic gastritis (body and/or antrum of stomach), intestinal metaplasia (complete and incomplete), dysplasia (any grade) and/or gastric cancer (post- treatment) Exclusion Criteria: Co-morbid illness that prohibit endoscopic surveillance Declines for study questionnaire, biobanking of specimens and/or regular review per study protocol

Ages Eligible for Study
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Minimum Age: 18 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

| Intervention/Treatment |
| --- |
|Diagnostic Test: Esophagogastroduodenoscopy|To set up a prospective study and registry (HAR-P) for patients with H. pylori infection, atrophic gastritis or intestinal metaplasia to evaluate their clinical features and outcomes. The objectives include: Assess the short- and long-term patient outcomes of H. pylori patients Characterize factors involved in the progression or regression of pre-neoplastic lesions, namely atrophic gastritis and intestinal metaplasia Gather information for a better understanding on the efficacy and role of surveillance Potential for the development of new screening/surveillance strategies and tools for better risk stratification of patients Establish a biobank for H. pylori, atrophic gastritis and intestinal metaplasia patients|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical outcomes of H. pylori patients | Prevalence of H. Pylori, atrophic gastritis, intestinal metaplasia, gastric cancer | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk factors of gastric pre-cancerous lesions and cancers | Proportion and risk factors for developing gastric pre-cancerous lesions and cancers | 3 years | 
| Risk factors of atrophic gastirtis | Proportion and risk factors for developing atrophic gastritis | 3 years | 
| Risk factors of intestinal metaplasia | Proportion and risk factors for developing intestinal metaplasia and progression | 3 years |