Intestinal Metaplasia Cohort for Gastric Cancer Prediction

Intestinal Metaplasia of Gastric Mucosa Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06075199
• Other study ID #: 2307-061-1448
• Status: Recruiting
• Start date: September 13, 2023
• Est. completion date: June 30, 2033

Study information

• Verified date: October 2023
• Source: Seoul National University Hospital
• Contact: Soo-Jeong Cho, MD, PhD
• Phone: 02-2072-4073
• Email: crystal5[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: June 30, 2033
• Est. primary completion date: June 30, 2033
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Intestinal Metaplasia of Gastric Mucosa
• Metaplasia

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gastric Cancer Development	Number of Participants Who Develop Gastric Cancer	10 years