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NCT Number: NCT05053945

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Prince of Wales Hospital, Hong Kong

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Esophagogastroduodenoscopy

Diagnostic Test

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

Primary outcomes

  1. Clinical outcomes of H. pylori patients

    Time frame: 3 years

    Prevalence of H. Pylori, atrophic gastritis, intestinal metaplasia, gastric cancer

Secondary outcomes

  1. Risk factors of gastric pre-cancerous lesions and cancers

    Time frame: 3 years

    Proportion and risk factors for developing gastric pre-cancerous lesions and cancers

  2. Risk factors of atrophic gastirtis

    Time frame: 3 years

    Proportion and risk factors for developing atrophic gastritis

  3. Risk factors of intestinal metaplasia

    Time frame: 3 years

    Proportion and risk factors for developing intestinal metaplasia and progression

Study contacts

Contact information is provided by the study sponsor or research team.

Andrew Ming Yeung HO

CONTACT

[email protected]

26371398

Thomas Yuen Tung LAM

CONTACT

[email protected]

26370355

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Sep 23, 2021
Registry last updated
Aug 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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