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

Active, not recruitingOBSERVATIONAL
Enrollment

500

Participants

Timeline

Start Date

August 23, 2019

Primary Completion Date

December 31, 2027

Study Completion Date

December 31, 2033

Conditions
Stomach Neoplasm
Interventions
PROCEDURE

Blood Collection, processing and analyses

20ml of blood will be drawn from study participant at the baseline visit for molecular analyses.

PROCEDURE

Gastroscopy and biopsies collection

Study participant will undergo gastroscopy with collection of gastric mucosal biopsies at the baseline visit to ascertain OLGIM status and for molecular analyses. Study participant will undergo surveillance gastroscopy for gastric cancer at years 2 and 4 to assess whether they have reached endpoint.

DIAGNOSTIC_TEST

Urea Breath Test

Study participant will fast for 6 hours or overnight before undergoing the Urea Breath Test (UBT) to test for current H. pylori infection. Breath collection will be performed before ingestion of 13C urea, and at specified time intervals after ingestion.

Trial Locations (8)

94305

Stanford University, Stanford

119074

National University Hospital, Singapore

169608

Singapore General Hospital, Singapore

308433

Tan Tock Seng Hospital, Singapore, Singapore

Unknown

The Chinese University of Hong Kong, Hong Kong

Nihon University School of Medicine, Tokyo

Yonsei University, Republic of Korea, Seoul

National Taiwan University Hospital, Taipei

All Listed Sponsors
collaborator

Tan Tock Seng Hospital

OTHER

collaborator

Singapore General Hospital

OTHER

collaborator

Yonsei University

OTHER

collaborator

Stanford University

OTHER

collaborator

Chinese University of Hong Kong

OTHER

collaborator

Nihon University

OTHER

collaborator

National Taiwan University Hospital

OTHER

lead

National University Hospital, Singapore

OTHER

NCT05782465 - Validation of a Molecular Test for Risk-stratification of Patients With High-risk Intestinal Metaplasia (GCEP2 Study) | Biotech Hunter | Biotech Hunter