Helicobacter PyloriNCT05053945
Helicobacter Pylori, Atrophic Gastritis and Intestinal Metaplasia Registry and Prospective Study
An observational study of Helicobacter Pylori and Atrophic Gastritis, run by Chinese University of Hong Kong at 2 sites in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Helicobacter Pylori, Atrophic Gastritis, Intestinal Metaplasia
- What is being tested?
- Esophagogastroduodenoscopy
- How many people
- 260 participants
- Where
- 2 sitesHong Kong
- Study dates
- 15 May 2020to 31 Dec 2030
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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)
Who cannot join
- Co-morbid illness that prohibit endoscopic surveillance
- Declines for study questionnaire, biobanking of specimens and/or regular review per study protocol
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong2 sites, 2 recruiting
- Recruiting
Prince of Wales Hospital
Hong Kong
Thomas Yuen Tung Lam, MSc, 26370355, thomaslam@cuhk.edu.hk
- Recruiting
S.H. Ho Centre for Digestive Health, Prince of Wales Hospital
Hong Kong
Ming Yeung HO
About this 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.
Read the 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.
- Being tested
- Esophagogastroduodenoscopy
- Medical subject headings
- Gastritis, Atrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsophagogastroduodenoscopyDiagnostic 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
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical outcomes of H. pylori patients
Prevalence of H. Pylori, atrophic gastritis, intestinal metaplasia, gastric cancer
Measured: 3 years
Secondary outcomes (3)
Risk factors of gastric pre-cancerous lesions and cancers
Proportion and risk factors for developing gastric pre-cancerous lesions and cancers
Measured: 3 years
Risk factors of atrophic gastirtis
Proportion and risk factors for developing atrophic gastritis
Measured: 3 years
Risk factors of intestinal metaplasia
Proportion and risk factors for developing intestinal metaplasia and progression
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2021
- Study start15 May 2020
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Helicobacter PyloriStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 260 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Louis Ho Shing Lau, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05053945
- Sponsor's protocol ID
- HAR-P Protocol_v1
- Status last verified
- Sep 2026
- First submitted
- 14 Jul 2020
- Last updated
- 22 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Helicobacter Pylori, Atrophic Gastritis and Intestinal Metaplasia Registry and Prospective Study
- ClinicalTrials.gov ID
- NCT05053945
- Acronym / sponsor ID
- HAR-P Protocol_v1
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 15 May 2020 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 23 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (2 listed)
- Co-morbid illness that prohibit endoscopic surveillance
- Declines for study questionnaire, biobanking of specimens and/or regular review per study protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EsophagogastroduodenoscopyTo 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 | Diagnostic test | – |
Primary outcome
Clinical outcomes of H. pylori patients
Time frame: 3 years
Prevalence of H. Pylori, atrophic gastritis, intestinal metaplasia, gastric cancer
3 secondary outcomes
Risk factors of gastric pre-cancerous lesions and cancers
Time frame: 3 years
Risk factors of atrophic gastirtis
Time frame: 3 years
Risk factors of intestinal metaplasia
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Helicobacter Pylori and Atrophic Gastritis, run by Chinese University of Hong Kong at 2 sites in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrew Ming Yeung HO (26371398, andrewho@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical outcomes of H. pylori patients (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.