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

Helicobacter Pylori Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05053945
• Other study ID #: HAR-P Protocol_v1
• Status: Recruiting
• Start date: May 15, 2020
• Est. completion date: December 31, 2025

Study information

• Verified date: February 2023
• Source: Chinese University of Hong Kong
• Contact: Andrew Ming Yeung HO
• Phone: 26371398
• Email: andrewho[@]cuhk.edu.hk
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 260
• Est. completion date: December 31, 2025
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrophic Gastritis
• Atrophy
• Gastritis
• Gastritis, Atrophic
• Helicobacter Pylori
• Intestinal Metaplasia
• Metaplasia

Intervention

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

Locations

Country	Name	City	State
Hong Kong	Prince of Wales Hospital	Hong Kong
Hong Kong	S.H. Ho Centre for Digestive Health, Prince of Wales Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical outcomes of H. pylori patients	Prevalence of H. Pylori, atrophic gastritis, intestinal metaplasia, gastric cancer	3 years
Secondary	Risk factors of gastric pre-cancerous lesions and cancers	Proportion and risk factors for developing gastric pre-cancerous lesions and cancers	3 years
Secondary	Risk factors of atrophic gastirtis	Proportion and risk factors for developing atrophic gastritis	3 years
Secondary	Risk factors of intestinal metaplasia	Proportion and risk factors for developing intestinal metaplasia and progression	3 years