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

NCT ID: NCT05053945

Last Updated: 2024-08-29

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 260 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-05-15
• Study Completion Date: 2025-12-31

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, the establishment of a registry for a longitudinal study is planned.

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.

Conditions

Helicobacter Pylori; Atrophic Gastritis; Intestinal Metaplasia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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:

1. Assess the short- and long-term patient outcomes of H. pylori patients

2. Characterize factors involved in the progression or regression of pre-neoplastic lesions, namely atrophic gastritis and intestinal metaplasia

3. Gather information for a better understanding on the efficacy and role of surveillance

4. Potential for the development of new screening/surveillance strategies and tools for better risk stratification of patients

5. Establish a biobank for H. pylori, atrophic gastritis and intestinal metaplasia patients

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Louis Ho Shing Lau

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Prince of Wales Hospital

Hong Kong, , Hong Kong

Site Status: RECRUITING

S.H. Ho Centre for Digestive Health, Prince of Wales Hospital

Hong Kong, , Hong Kong

Site Status: RECRUITING

Countries

Hong Kong

Central Contacts

Andrew Ming Yeung HO

Role: CONTACT

andrewho@cuhk.edu.hk

26371398

Thomas Yuen Tung LAM

Role: CONTACT

thomaslam@cuhk.edu.hk

26370355

Facility Contacts

Thomas Yuen Tung Lam, MSc

Role: primary

thomaslam@cuhk.edu.hk

26370355

Ming Yeung HO

Role: primary

Other Identifiers

HAR-P Protocol_v1

Identifier Type: -

Identifier Source: org_study_id