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NCT05782465

Validation of a Molecular Test for Risk-stratification of Patients With High-risk Intestinal Metaplasia (GCEP2 Study)

Sponsor: National University Hospital, Singapore

View on ClinicalTrials.gov

Summary

This study is carried out to find out if a customized molecular test can identify a subgroup of patients with very-high-risk of developing stomach cancer within patients with intestinal metaplasia (IM). The investigators hypothesise that the incidence of dysplasia and GC cases in the molecular-test-positive group will be significantly higher than that in the molecular-test-negative group. Such a test has the potential to guide clinicians to better manage patients with IM by allowing endoscopic surveillance to be focused on individuals at very-high-risk of developing stomach cancer, at the same time avoiding or reducing endoscopies for those at lower risk.

Key Details

Gender

All

Age Range

50 Years - 75 Years

Study Type

OBSERVATIONAL

Enrollment

500

Start Date

2019-08-23

Completion Date

2033-12

Last Updated

2025-04-18

Healthy Volunteers

No

Interventions

PROCEDURE

Blood Collection, processing and analyses

20ml of blood will be drawn from study participant at the baseline visit for molecular analyses.

PROCEDURE

Gastroscopy and biopsies collection

Study participant will undergo gastroscopy with collection of gastric mucosal biopsies at the baseline visit to ascertain OLGIM status and for molecular analyses. Study participant will undergo surveillance gastroscopy for gastric cancer at years 2 and 4 to assess whether they have reached endpoint.

DIAGNOSTIC_TEST

Urea Breath Test

Study participant will fast for 6 hours or overnight before undergoing the Urea Breath Test (UBT) to test for current H. pylori infection. Breath collection will be performed before ingestion of 13C urea, and at specified time intervals after ingestion.

Locations (8)

Stanford University

Stanford, California, United States

The Chinese University of Hong Kong

Hong Kong, Hong Kong

Nihon University School of Medicine

Tokyo, Japan

Singapore General Hospital

Singapore, Singapore, Singapore

Tan Tock Seng Hospital, Singapore

Singapore, Singapore, Singapore

National University Hospital

Singapore, Singapore

Yonsei University, Republic of Korea

Seoul, South Korea

National Taiwan University Hospital

Taipei, Taiwan