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History of Changes for Study: NCT05053945
Helicobacter Pylori, Atrophic Gastritis and Intestinal Metaplasia Registry and Prospective Study
Latest version (submitted September 13, 2021) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 September 13, 2021 None (earliest Version on record)
Comparison Format:

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Study NCT05053945
Submitted Date:  September 13, 2021 (v1)

Open or close this module Study Identification
Unique Protocol ID: HAR-P Protocol_v1
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
Secondary IDs:
Open or close this module Study Status
Record Verification: September 2021
Overall Status: Recruiting
Study Start: May 15, 2020
Primary Completion: February 2, 2023 [Anticipated]
Study Completion: March 1, 2023 [Anticipated]
First Submitted: July 14, 2020
First Submitted that
Met QC Criteria:
September 13, 2021
First Posted: September 23, 2021 [Actual]
Last Update Submitted that
Met QC Criteria:
September 13, 2021
Last Update Posted: September 23, 2021 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Chinese University of Hong Kong
Responsible Party: Principal Investigator
Investigator: Louis Ho Shing Lau
Official Title: Resident Specialist
Affiliation: Chinese University of Hong Kong
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring:
Open or close this module Study Description
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.
Open or close this module Conditions
Conditions: Helicobacter Pylori
Atrophic Gastritis
Intestinal Metaplasia
Keywords:
Open or close this module Study Design
Study Type: Observational [Patient Registry]
Observational Study Model: Cohort
Time Perspective: Prospective
Biospecimen Retention:
Biospecimen Description:
Enrollment: 260 [Anticipated]
Number of Groups/Cohorts 0
Target Follow-Up Duration: 3 Years
Open or close this module Groups and Interventions
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
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Assess the outcomes of H. pylori patients
[ Time Frame: 3 years ]

Detection of H. Pylori, atrophic gastritis, intestinal metaplasia, gastric cancer.
Secondary Outcome Measures:
1. Characterize factors of lesions
[ Time Frame: 3 years ]

Descriptive statistics on factors of lesions
2. Characterize factors of atrophic gastirtis
[ Time Frame: 3 years ]

Descriptive statistics on atrophic gastritis
3. Characterize factors of intestinal metaplasia
[ Time Frame: 3 years ]

Descriptive statistics on intestinal metaplasia
Open or close this module Eligibility
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

Sampling Method: Probability Sample
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
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
Open or close this module Contacts/Locations
Central Contact Person: Andrew Ming Yeung HO
Telephone: 26371398
Email: andrewho@cuhk.edu.hk
Central Contact Backup: Thomas Yuen Tung LAM
Telephone: 26370355
Email: thomaslam@cuhk.edu.hk
Locations: Hong Kong
Prince of Wales Hospital
[Recruiting]
Hong Kong, Hong Kong
Contact: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:Contact: Ming Yeung HO
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

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