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

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ClinicalTrials.gov Identifier: NCT05053945
Recruitment Status : Recruiting
First Posted : September 23, 2021
Last Update Posted : September 23, 2021
Sponsor:
Information provided by (Responsible Party):
Louis Ho Shing Lau, Chinese University of Hong Kong

Tracking Information
First Submitted Date July 14, 2020
First Posted Date September 23, 2021
Last Update Posted Date September 23, 2021
Actual Study Start Date May 15, 2020
Estimated Primary Completion Date February 2, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 13, 2021)		 Assess the outcomes of H. pylori patients [ Time Frame: 3 years ]
Detection of H. Pylori, atrophic gastritis, intestinal metaplasia, gastric cancer.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: September 13, 2021)
  • Characterize factors of lesions [ Time Frame: 3 years ]
    Descriptive statistics on factors of lesions
  • Characterize factors of atrophic gastirtis [ Time Frame: 3 years ]
    Descriptive statistics on atrophic gastritis
  • Characterize factors of intestinal metaplasia [ Time Frame: 3 years ]
    Descriptive statistics on intestinal metaplasia
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Helicobacter Pylori, Atrophic Gastritis and Intestinal Metaplasia Registry and Prospective Study
Official Title Helicobacter Pylori, Atrophic Gastritis and Intestinal Metaplasia Registry and Prospective Study
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, we propose for the establishment of a registry for a longitudinal study with the hopes of changing clinical practice in the near future.
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 alone1. It is a major cause of peptic ulcer disease and is implicated in the pathogenesis of the majority of gastric cancers2. Since 1994, the World Health Organization has designated H. pylori infection as a class 1 carcinogen3. Gastric cancer was the sixth commonest malignancy in Hong Kong in 20154; it was also the second commonest cause of death from cancer in Asia5. 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 carcinoma6. 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 regression7,8. 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 cancer9. However, in countries with a lower incidence of gastric cancer, this population-based approach may not be cost-effective10. 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 techniques11. To solve these important clinical questions, we propose for the establishment of a registry for a longitudinal study with the hopes of changing clinical practice in the near future.
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 3 Years
Biospecimen Not Provided
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
Condition
  • Helicobacter Pylori
  • Atrophic Gastritis
  • Intestinal 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:

  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
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: September 13, 2021)		 260
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 1, 2023
Estimated Primary Completion Date February 2, 2023   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Andrew Ming Yeung HO 26371398 andrewho@cuhk.edu.hk
Contact: Thomas Yuen Tung LAM 26370355 thomaslam@cuhk.edu.hk
Listed Location Countries Hong Kong
Removed Location Countries  
 
Administrative Information
NCT Number NCT05053945
Other Study ID Numbers HAR-P Protocol_v1
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party Louis Ho Shing Lau, Chinese University of Hong Kong
Original Responsible Party Same as current
Current Study Sponsor Chinese University of Hong Kong
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators Not Provided
PRS Account Chinese University of Hong Kong
Verification Date September 2021