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Clinical Trials/NCT06075199
NCT06075199
Recruiting
Not Applicable

A Prospective Cohort Study for Gastric Cancer Prediction in Patients With Intestinal Metaplasia

Seoul National University Hospital1 site in 1 country1,000 target enrollmentSeptember 13, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Intestinal Metaplasia of Gastric Mucosa
Sponsor
Seoul National University Hospital
Enrollment
1000
Locations
1
Primary Endpoint
Gastric Cancer Development
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

In this study, we aim to establish a prospective cohort of patients with endoscopically and histologically confirmed intestinal metaplasia, collect gastric mucosal tissue samples from this cohort, and follow the development of gastric cancer over time.

Detailed Description

Patients visiting Seoul National University Hospital, who have previously received an incidental diagnosis of intestinal metaplasia during a prior gastroscopy examination, will be considered as potential candidates for this study. Upon obtaining their informed consent to participate, the initial endoscopy procedure will involve the collection of biopsies to ensure an accurate histological diagnosis of intestinal metaplasia. These biopsies will be taken from the antrum and body of the stomach, according to the protocol of the updated Sydney system, to pathologically diagnose the extent and severity of intestinal metaplasia. One to two pieces of tissue remaining from this diagnostic process will be retained for future analysis. Subsequently, patients will be followed up on an outpatient basis to track the development of gastric cancer through routine screening endoscopies. In cases where patients develop gastric cancer, a comparative analysis will be conducted with those who do not develop gastric cancer, to determine the differences in expression of markers in the gastric mucosal tissue that was collected during the initial endoscopy. Our ultimate aim is to identify potential biomarkers that may serve as predictive indicators for the development of gastric cancer in patients with a preexisting diagnosis of intestinal metaplasia.

Registry
clinicaltrials.gov
Start Date
September 13, 2023
End Date
June 30, 2033
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Soo-Jeong Cho

Professor

Seoul National University Hospital

Eligibility Criteria

Inclusion Criteria

  • Patients who visit Seoul National University Hospital
  • Patients who have been visually diagnosed with intestinal metaplasia at a prior exam

Exclusion Criteria

  • Patients who have been previously diagnosed with gastric cancer or adenoma
  • Patients who have previously received gastrectomy

Outcomes

Primary Outcomes

Gastric Cancer Development

Time Frame: 10 years

Number of Participants Who Develop Gastric Cancer

Study Sites (1)

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