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Validation of a Molecular Test for Risk-stratification of Patients With High-risk Intestinal Metaplasia (GCEP2 Study)
Sponsor: National University Hospital, Singapore
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
Conditions
Interventions
Blood Collection, processing and analyses
20ml of blood will be drawn from study participant at the baseline visit for molecular analyses.
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.
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