Atrophic Gastritis Predicts the Risk of Gastric Cancer

January 13, 2024 updated by: Hong Lu, MD, Shanghai Jiao Tong University School of Medicine

Atrophic Gastritis Predicts the Risk of Gastric Cancer: a Prospective Cohort Study

Despite declining incidence rates, gastric cancer (GC) ranks the fourth leading cause of cancer-related mortality and the fifth most common cancer worldwide, with the highest incidence reported in Eastern Asia. The 5-year overall survival rate of early GC exceeds 90%, which was well above advanced GC. Most intestinal-type GCs follow the Correa cascade-inflammation,atrophy, intestinal metaplasia (IM), dysplasia and subsequent carcinoma. The presence of gastric mucosal atrophy and intestinal metaplasia are important risk factors for GC. The purpose of this study was to investigate the incidence of GC attributed to atrophic gastritis in a region with high incidence of GC.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

2042

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200127
        • Recruiting
        • Renji Hospital, School of Medicine, Shanghai Jiao Tong University
        • Principal Investigator:
          • Hong Lu, M.D.,Ph.D
        • Sub-Investigator:
          • Xiao Liang, M.D.,Ph.D
        • Contact:
        • Sub-Investigator:
          • Jinnan Chen, M.M.
        • Sub-Investigator:
          • Yixian Guo, M.M.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Chronic gastritis diagnosed by routine endoscopic screening

Description

Inclusion Criteria:

  • Ability and willingness to participate in the study and to sign and give informed consent
  • Biopsies were collected based on the recommendation of updated Sydney system

Exclusion Criteria:

  • under 18 or over 80 years old
  • history of gastrectomy
  • severe systemic diseases or malignancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
OLGA 0-I
Other: Esophagogastroscopy (OLGA 0-Ⅰ)
Surveillance endoscopies at years 3-5.
OLGA II
Other: Esophagogastroscopy (OLGA II)
Surveillance endoscopies at years 2-3.
OLGA III-IV
Other: Esophagogastroscopy (OLGA III-IV)
Surveillance endoscopies every year.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
early gastric neoplasm
Time Frame: After the baseline endoscopy, participants were scheduled for surveillance endoscopies at years 3-5 for subjects with operative link on gastritis assessment (OLGA) 0-Ⅰ, at years 2-3 for subjects with OLGA II and 1 year for subjects with OLGA III-IV.
histological diagnosis of high-grade dysplasia, and adenocarcinoma.
After the baseline endoscopy, participants were scheduled for surveillance endoscopies at years 3-5 for subjects with operative link on gastritis assessment (OLGA) 0-Ⅰ, at years 2-3 for subjects with OLGA II and 1 year for subjects with OLGA III-IV.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Jiao Tong University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Estimated)

December 31, 2034

Study Completion (Estimated)

December 31, 2034

Study Registration Dates

First Submitted

December 25, 2023

First Submitted That Met QC Criteria

January 11, 2024

First Posted (Actual)

January 12, 2024

Study Record Updates

Last Update Posted (Estimated)

January 17, 2024

Last Update Submitted That Met QC Criteria

January 13, 2024

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • rjhy20230004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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