Fact CheckerSign in

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
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

Full criteria on ClinicalTrials.gov

Sites (8)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The Chinese University of Hong Kong
Coordinator of this site? Confirm its status
Hong KongHong Kong SAR ChinaUnknown status
Nihon University School of Medicine
Coordinator of this site? Confirm its status
TokyoJapanUnknown status
Yonsei University, Republic of Korea
Coordinator of this site? Confirm its status
SeoulSouth KoreaUnknown status
Singapore General Hospital
Coordinator of this site? Confirm its status
SingaporeSingaporeUnknown status
National University Hospital
Coordinator of this site? Confirm its status
SingaporeSingaporeUnknown status
Tan Tock Seng Hospital, Singapore
Coordinator of this site? Confirm its status
SingaporeSingaporeUnknown status
National Taiwan University Hospital
Coordinator of this site? Confirm its status
TaipeiTaiwanUnknown status
Stanford University
Coordinator of this site? Confirm its status
StanfordUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.