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Recruiting NCT06075199

Intestinal Metaplasia Cohort for Gastric Cancer Prediction

Observational Intestinal Metaplasia of Gastric Mucosa

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Intestinal Metaplasia of Gastric Mucosa. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Primary outcome measures

  • Gastric Cancer Development [Time frame: 10 years]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

South Korea · 1 center
  • Seoul National University Hospital — Seoul

Identifiers

NCT: NCT06075199 · 2307-061-1448

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗