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

Active Not RecruitingN/A

Sponsor: National University Hospital, Singapore

Conditions: Stomach Neoplasm

Interventions: Blood Collection, processing and analyses, Gastroscopy and biopsies collection, Urea Breath Test

Countries: United States, Hong Kong, Japan, Singapore, South Korea, Taiwan

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.

Eligibility overview

Sex: ALL

Age: 50 Years to 75 Years

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion Criteria:

1. The subject is above 50 years old or turns 50 years old in the year of recruitment
2. The subject is below 76 years old in the year of recruitment
3. 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

Exclusion Criteria:

1. The subject who has bleeding disorders, such as haemophilia, in whom biopsies are contraindicated.
2. The subject with a personal history of high-grade dysplasia or GC.
3. The subject with liver cirrhosis.
4. The subject with previous total or partial gastrectomy.
5. 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.
6. 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.
7. 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.
8. The subject is unwilling or unable to provide signed informed consent.

Locations (8)

Stanford, California, United States
Hong Kong, Hong Kong
Tokyo, Japan
Singapore, Singapore
Singapore, Singapore
Singapore, Singapore
Seoul, South Korea
Taipei, Taiwan