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

Official record

Identifier

NCT05782465

Recruiting locations

countries

United StatesHong KongJapanSingaporeSouth KoreaTaiwan

Interventions studied

Blood Collection, processing and analysesGastroscopy and biopsies collectionUrea Breath Test

Lead sponsor

National University Hospital, Singapore

Target enrolment

500 participants

Study type

OBSERVATIONAL

Phase

Not provided in the official record

Status

Active, not recruiting

First posted

Mar 23, 2023

Last updated on the registry

Aug 7, 2026

Age

50 Years – 75 Years

Sex

ALL

Study contact

No public contact is listed on the official record.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

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.

Indexed under

Gastric Cancer