This study is intended to be a prospective observational study at multiple sites, not a randomized controlled trial (RCT). The uses of the biomarkers has been approved by government regulations and adopted for surveillance programs in some countries, thus an RCT which compares patients followed by US alone with patients followed by both US and the biomarkers would raise an ethical conflict, especially in countries where the biomarkers have been routinely used. For this study, enrolled patients will be followed by US and the biomarkers at regular intervals and classified after completing the study to evaluate the clinical effectiveness of the biomarkers. The comparisons of sensitivity, specificity, and other parameters with respect to tumor characteristics will be made among US alone, the biomarkers, and combined use of US and the biomarkers. Also economical effectiveness of using the biomarkers will be investigated in this study. Requirement status is monitored every month.
Data are being stored in the electric data capture (EDC) server.
Study Type
OBSERVATIONAL
Enrollment
1,000
Graduate School of Medicine and Faculty of Medicine, The University of Tokyo
Tokyo, Japan
Hepatocellular carcinoma
Tumor marker measurement and ultrasonography are conducted at an interval of 13 weeks, until total events (HCC occurrence) reach to 120 cases.
Time frame: Expected time frame; 2.5 years
Survival
Time frame: 2 and 5 year after patient enrollment
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