Helicobacter Pylori, Atrophic Gastritis and Intestinal Metaplasia Registry and Prospective Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorChinese University of Hong Kong
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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)
Disqualifiers
Co-morbid illness that prohibit endoscopic surveillance
Declines for study questionnaire, biobanking of specimens and/or regular review per study protocol
Trial 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
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Esophagogastroduodenoscopy
Diagnostic testTo 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
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Clinical outcomes of H. pylori patients
Prevalence of H. Pylori, atrophic gastritis, intestinal metaplasia, gastric cancer
Time frame
3 yearsSecondary outcomes
1
Risk factors of gastric pre-cancerous lesions and cancers
Proportion and risk factors for developing gastric pre-cancerous lesions and cancers
Time frame
3 years2
Risk factors of atrophic gastirtis
Proportion and risk factors for developing atrophic gastritis
Time frame
3 years3
Risk factors of intestinal metaplasia
Proportion and risk factors for developing intestinal metaplasia and progression
Time frame
3 yearsSponsors and contacts
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Source ClinicalTrials.gov