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
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Sponsor:
Chinese University of Hong Kong
Information provided by (Responsible Party):
Louis Ho Shing Lau, Chinese University of Hong Kong
Tracking Information | |||||||||
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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 |
Assess the outcomes of H. pylori patients [ Time Frame: 3 years ] Detection of H. Pylori, atrophic gastritis, intestinal metaplasia, gastric cancer.
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Original Primary Outcome Measures | Same as current | ||||||||
Change History | No Changes Posted | ||||||||
Current Secondary Outcome Measures |
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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 |
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Target Follow-Up Duration | 3 Years | ||||||||
Biospecimen | Not Provided | ||||||||
Sampling Method | Probability Sample | ||||||||
Study Population | Inclusion Criteria
1. Co-morbid illness that prohibit endoscopic surveillance 2. Declines for study questionnaire, biobanking of specimens and/or regular review per study protocol |
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Condition |
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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:
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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. |
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Recruitment Information | |||||||||
Recruitment Status | Recruiting | ||||||||
Estimated Enrollment |
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:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers | Yes | ||||||||
Contacts |
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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 |
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IPD Sharing Statement |
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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 |