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

NCT05053945 | Recruiting

• 1 other identifier: HAR-P Protocol_v1
• Study Type: observational
• Target: 260
• Locations: 1 country
• Sites: 2

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, the establishment of a registry for a longitudinal study is planned.

Conditions

Helicobacter Pylori; Atrophic Gastritis; Intestinal Metaplasia

Outcome Measures

Primary Outcomes (1)

• Clinical outcomes of H. pylori patients

  Prevalence of H. Pylori, atrophic gastritis, intestinal metaplasia, gastric cancer

  3 years

Secondary Outcomes (3)

• Risk factors of gastric pre-cancerous lesions and cancers

  3 years

• Risk factors of atrophic gastirtis

  3 years

• Risk factors of intestinal metaplasia

  3 years

Interventions

Esophagogastroduodenoscopy DIAGNOSTIC_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: 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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)

You may not qualify if:

• Co-morbid illness that prohibit endoscopic surveillance
• Declines for study questionnaire, biobanking of specimens and/or regular review per study protocol

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (2)

Prince of Wales Hospital

Hong Kong, Hong Kong

RECRUITING

S.H. Ho Centre for Digestive Health, Prince of Wales Hospital

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Gastritis, Atrophic

Interventions

Endoscopy, Digestive System

Condition Hierarchy (Ancestors)

Gastritis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Central Study Contacts

Andrew Ming Yeung HO

CONTACT

26371398; andrewho@cuhk.edu.hk

Thomas Yuen Tung LAM

CONTACT

26370355; thomaslam@cuhk.edu.hk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 14, 2020
• First Posted: September 23, 2021
• Study Start: May 15, 2020
• Primary Completion: December 1, 2025
• Study Completion: December 31, 2025
• Last Updated: August 29, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

HK (2)