An observational study in Liver Cancer, Liver Cirrhosis and Hepatocellular Carcinoma, sponsored by Johns Hopkins University. Terminated at 10 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-12.
Sponsored by Johns Hopkins University · Observational
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.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's enrollment of 360 is above the median of 149 across 1,175 observational studies indexed under Carcinoma.
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Persons with compensated cirrhosis (e.g. MELD 15 or lower)
Exclusion Criteria:
GALAD score, a blood-based biomarker panel (gender, age, AFP, AFP-L3%, DCP)
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
Plan to share: Undecided
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This study is terminated, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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