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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05053945
Recruitment Status : Recruiting
First Posted : September 23, 2021
Last Update Posted : February 8, 2023
Sponsor:
Information provided by (Responsible Party):
Louis Ho Shing Lau, Chinese University of Hong Kong

Study Description
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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.

Condition or disease Intervention/treatment
Helicobacter Pylori Atrophic Gastritis Intestinal Metaplasia 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 Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 260 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: Helicobacter Pylori, Atrophic Gastritis and Intestinal Metaplasia Registry and Prospective Study
Actual Study Start Date : May 15, 2020
Estimated Primary Completion Date : December 1, 2025
Estimated Study Completion Date : December 31, 2025
Groups and Cohorts
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Intervention Details:
  • 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:

    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

Outcome Measures
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Primary Outcome Measures :
  1. Clinical outcomes of H. pylori patients [ Time Frame: 3 years ]
    Prevalence of H. Pylori, atrophic gastritis, intestinal metaplasia, gastric cancer


Secondary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05053945


Contacts
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Contact: Andrew Ming Yeung HO 26371398 andrewho@cuhk.edu.hk
Contact: Thomas Yuen Tung LAM 26370355 thomaslam@cuhk.edu.hk

Locations
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Hong Kong
Prince of Wales Hospital Recruiting
Hong Kong, Hong Kong
Contact: Thomas Yuen Tung Lam, MSc    26370355    thomaslam@cuhk.edu.hk   
S.H. Ho Centre for Digestive Health, Prince of Wales Hospital Recruiting
Hong Kong, Hong Kong
Contact: Ming Yeung HO         
Sponsors and Collaborators
Chinese University of Hong Kong
More Information
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Responsible Party: Louis Ho Shing Lau, Assistant Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT05053945    
Other Study ID Numbers: HAR-P Protocol_v1
First Posted: September 23, 2021    Key Record Dates
Last Update Posted: February 8, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Gastritis
Gastritis, Atrophic
Atrophy
Metaplasia
Pathological Conditions, Anatomical
 Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Pathologic Processes