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

Running, not enrolling

Conditions studied: Stomach Neoplasm

In brief

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 facts

Study ID

NCT05782465

Run by

National University Hospital, Singapore

People needed

500

Starts

2019-08-23

Expected to finish

2033-12-01

Last updated by the study team

2026-08-07

Who can join

Age: 50 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The subject is above 50 years old or turns 50 years old in the year of recruitment
• The subject is below 76 years old in the year of recruitment
• The subject is willing and able to provide signed and dated patient informed consent form indicating that they has been informed of all pertinent aspects of the study

You may not qualify if…

• The subject who has bleeding disorders, such as haemophilia, in whom biopsies are contraindicated.
• The subject with a personal history of high-grade dysplasia or GC.
• The subject with liver cirrhosis.
• The subject with previous total or partial gastrectomy.
• The subject with severe co-morbid illness, such as end-stage renal failure (ESRF), congestive cardiac failure (CCF), severe osteoarthritis (OA), and rheumatoid arthritis (RA) requiring long-term non-steroidal anti-inflammatory drug (NSAID) therapy.
• The subject with other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may interfere with the interpretation of study results and in the judgement of the investigator would make the subject unsuitable for entry into the study.
• The subject on regular anti-coagulant prophylaxis such as warfarin must be able to undergo a 5-day washout period before each gastroscopy. The subject on aspirin, ticlopidine and clopidogrel must be able to undergo a one-week washout period before each gastroscopy. The subject's physician or study co-investigator will exercise their clinical judgement to ensure subject's safety.
• The subject is unwilling or unable to provide signed informed consent.

Where it is running

• Stanford University — Stanford, California, United States
• The Chinese University of Hong Kong — Hong Kong, Hong Kong
• Nihon University School of Medicine — Tokyo, Japan
• National University Hospital — Singapore, Singapore
• Singapore General Hospital — Singapore, Singapore
• Tan Tock Seng Hospital, Singapore — Singapore, Singapore
• Yonsei University, Republic of Korea — Seoul, South Korea
• National Taiwan University Hospital — Taipei, Taiwan

Full record on ClinicalTrials.gov

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