NCT05782465Active, not recruiting
Validation of a Molecular Test for Risk-stratification of Patients With High-risk Intestinal Metaplasia (GCEP2 Study)
Source: ClinicalTrials.gov · Last updated 7 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 500 (estimated)
- First submitted
- 13 Mar 2023
- Start date
- 23 Aug 2019
- Primary completion date
- Dec 2027
- Lead sponsor
- National University Hospital, Singapore
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT05782465
What you commit to
- Study type: Observational
- Planned participants: 500
- From 23 Aug 2019 to the primary completion date, Dec 2027
- 8 sites in 6 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- The subject with previous total or partial gastrectomy.
- 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.
Other illness
- 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 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.
Lab values
- 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.
Other
- The subject with liver cirrhosis.
- The subject is unwilling or unable to provide signed informed consent.
Who the study is looking for
- 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
Age in the registry: 50 years to 75 years · Sex: All
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Chinese University of Hong Kong Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Unknown status |
| Nihon University School of Medicine Coordinator of this site? Confirm its status | Tokyo | Japan | Unknown status |
| Yonsei University, Republic of Korea Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Singapore General Hospital Coordinator of this site? Confirm its status | Singapore | Singapore | Unknown status |
| National University Hospital Coordinator of this site? Confirm its status | Singapore | Singapore | Unknown status |
| Tan Tock Seng Hospital, Singapore Coordinator of this site? Confirm its status | Singapore | Singapore | Unknown status |
| National Taiwan University Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Stanford University Coordinator of this site? Confirm its status | Stanford | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.