Intestinal Metaplasia Cohort for Gastric Cancer Prediction

Sponsor

Seoul National University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT06075199

Collaborator

(none)

1,000

Enrollment

Location

117.6

Anticipated Duration (Months)

8.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Intestinal Metaplasia of Gastric Mucosa

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.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

1000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Sep 13, 2023

Anticipated Primary Completion Date :

Jun 30, 2033

Anticipated Study Completion Date :

Jun 30, 2033

Outcome Measures

Primary Outcome Measures

Gastric Cancer Development [10 years]
Number of Participants Who Develop Gastric Cancer

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

Seoul National University Hospital

Investigators

Principal Investigator: Soo-Jeong Cho, MD, PhD, Seoul National University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Soo-Jeong Cho, Professor, Seoul National University Hospital

ClinicalTrials.gov Identifier:

NCT06075199

Other Study ID Numbers:

2307-061-1448

First Posted:

Oct 10, 2023

Last Update Posted:

Oct 10, 2023

Last Verified:

Oct 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Metaplasia

Study Results

No Results Posted as of Oct 10, 2023