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

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.

Study Overview

• Status: Recruiting
• Conditions: Intestinal Metaplasia; Helicobacter Pylori; Atrophic Gastritis
• Intervention / Treatment: Diagnostic test: Esophagogastroduodenoscopy

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 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.

• Study Type: Observational
• Enrollment (Estimated): 260

Contacts and Locations

• Study Contact: Name: Andrew Ming Yeung HO; Phone Number: 26371398; Email: andrewho@cuhk.edu.hk
• Study Contact Backup: Name: Thomas Yuen Tung LAM; Phone Number: 26370355; Email: thomaslam@cuhk.edu.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • Prince of Wales Hospital
    • Contact: Thomas Yuen Tung Lam, MSc; Phone Number: 26370355; Email: thomaslam@cuhk.edu.hk
  • Hong Kong, Hong Kong
    • Recruiting
    • S.H. Ho Centre for Digestive Health, Prince of Wales Hospital
    • Contact: Ming Yeung HO

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Inclusion Criteria

1. Adults >= 18 years of age
2. Written informed consent obtained
3. Diagnosed with current or past H. pylori infection,
4. 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

1. Co-morbid illness that prohibit endoscopic surveillance
2. Declines for study questionnaire, biobanking of specimens and/or regular review per study protocol

Description

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

Study Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2020
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: July 14, 2020
• First Submitted That Met QC Criteria: September 13, 2021
• First Posted (Actual): September 23, 2021

Study Record Updates

• Last Update Posted (Actual): August 29, 2024
• Last Update Submitted That Met QC Criteria: August 28, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Stomach Diseases; Gastroenteritis; Pathological Conditions, Anatomical; Gastritis; Atrophy; Metaplasia; Gastritis, Atrophic
• Other Study ID Numbers: HAR-P Protocol_v1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No