Helicobacter Pylori, Atrophic Gastritis and Intestinal Metaplasia Registry and Prospective Study
Study Details
Study Description
Brief Summary
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, we propose for the establishment of a registry for a longitudinal study with the hopes of changing clinical practice in the near future.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
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 alone1. It is a major cause of peptic ulcer disease and is implicated in the pathogenesis of the majority of gastric cancers2. Since 1994, the World Health Organization has designated H. pylori infection as a class 1 carcinogen3. Gastric cancer was the sixth commonest malignancy in Hong Kong in 20154; it was also the second commonest cause of death from cancer in Asia5. 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 carcinoma6. 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 regression7,8. 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 cancer9. However, in countries with a lower incidence of gastric cancer, this population-based approach may not be cost-effective10. 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 techniques11. To solve these important clinical questions, we propose for the establishment of a registry for a longitudinal study with the hopes of changing clinical practice in the near future.
Study Design
Outcome Measures
Primary Outcome Measures
- Assess the outcomes of H. pylori patients [3 years]
Detection of H. Pylori, atrophic gastritis, intestinal metaplasia, gastric cancer.
Secondary Outcome Measures
- Characterize factors of lesions [3 years]
Descriptive statistics on factors of lesions
- Characterize factors of atrophic gastirtis [3 years]
Descriptive statistics on atrophic gastritis
- Characterize factors of intestinal metaplasia [3 years]
Descriptive statistics on intestinal metaplasia
Eligibility Criteria
Criteria
Inclusion Criteria:
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Adults >= 18 years of age
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Written informed consent obtained
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Diagnosed with current or past H. pylori infection,
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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:
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Co-morbid illness that prohibit endoscopic surveillance
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Declines for study questionnaire, biobanking of specimens and/or regular review per study protocol
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Prince of Wales Hospital | Hong Kong | Hong Kong | ||
| 2 | S.H. Ho Centre for Digestive Health, Prince of Wales Hospital | Hong Kong | Hong Kong |
Sponsors and Collaborators
- Chinese University of Hong Kong
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HAR-P Protocol_v1