This study has two purposes. One is to conduct a phase IV biomarker validation study in which the investigators will prospectively survey a cohort of patients at risk for liver cancer using semi-annual abdominal ultrasound and GALAD Score for 5 years. The GALAD score is a serum biomarker-based panel that can aid in early detection among patients with a high risk for liver cancer. One is to establish a bio-repository of longitudinally collected bio-specimens from patients with fibrosis/cirrhosis as a reference set for future research.
Vietnam and Saudi Arabia have some of the highest disease burdens of liver cancer globally. Early detection in asymptomatic patients who are at risk for liver is a strategy to improve survival outcomes in liver cancer management. GALAD score (gender, age, alpha-feto protein (AFP)-L%, AFP and DCP) is a serum biomarker-based panel that can improve HCC early detection in patients with liver fibrosis and cirrhosis. In case-control studies and studies with the design of prospective specimen collection, and retrospective blinded evaluation, GALAD has demonstrated promising clinical utility. However, in order to ascertain its potential role in the surveillance of liver cancer early detection, GALAD needs to be validated prospectively for clinical surveillance of liver cancer (i.e. phase IV biomarker validation study). Thus, the investigators propose to conduct a phase IV biomarker validation study to prospectively survey a cohort of patients at risk for HCC (i.e. patients with compensated cirrhosis and irrespective of cirrhosis etiologies), using semi-annual abdominal ultrasound and GALAD Score for 5 years. In doing so, the investigators aim to validate the potential role of GALAD Score for clinical surveillance and early detection of HCC in Vietnam and Saudi Arabia. Additionally, the investigators will collect and archive biospecimens to develop a bio-repository for liver disease. The biorepository will encourage the sharing of biospecimens and collaboration among physicians or physician-researchers between the US, Vietnam, and Saudi Arabia.
Study Type
OBSERVATIONAL
Enrollment
360
GALAD score, a blood-based biomarker panel (gender, age, AFP, AFP-L3%, DCP)
King Faisal Specialist Hospital and Research Center in Jeddah
Jeddah, Saudi Arabia
National Guard Hospital in Jeddah
Jeddah, Saudi Arabia
King Faisal Specialist Hospital and Research Centre in Riyadh
Riyadh, Saudi Arabia
King Saud University Medical Center
Riyadh, Saudi Arabia
National Guard Hospital in Riyadh
Riyadh, Saudi Arabia
Binh An Hospital
Rach Gia, Kien Giang, Vietnam
Medic Ca Mau
Cà Mau, Vietnam
Dong Da Hospital
Hà Nội, Vietnam
Institute of Gastroenterology and Hepatology
Hà Nội, Vietnam
Medic Medical Center-Ho Chi Minh City
Ho Chi Minh City, Vietnam
GALAD performance for liver cancer early detection
Performance of GALAD score determined in association with liver cancer detection by LiRADS criteria in a cohort with compensated cirrhosis undergoing prospective surveillance every 6 months for 5 years.
Time frame: 5 years
Establishment of a bio-repository of longitudinally collected from patients with cirrhosis to be used for future studies
Proportion of study participants agrees to consent for bio-specimen when invited
Time frame: 5 years
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