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

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.

Conditions

• Stomach Neoplasm

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.

Sponsors & Collaborators

• Tan Tock Seng Hospital

  collaborator OTHER

• Singapore General Hospital

  collaborator OTHER

• Yonsei University

  collaborator OTHER

• Stanford University

  collaborator OTHER

• Chinese University of Hong Kong

  collaborator OTHER

• Nihon University

  collaborator OTHER

• National Taiwan University Hospital

  collaborator OTHER

• National University Hospital, Singapore

  lead OTHER

Principal Investigators

• Khay Guan Yeoh, MBBS, MMed · National University Hospital, Singapore

• Jonathan WJ Lee, MBBS, MRCP · National University Hospital, Singapore

Eligibility

Min Age

50 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-08-23

Primary Completion

2027-12-31

Completion

2033-12-31

Countries

• United States
• Hong Kong
• Japan
• Singapore
• South Korea
• Taiwan

Study Locations