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Surveillance Study for HCC by Combining Biomarkers With Imaging (ALDUS) — ALDUS  

Liver Cirrhosis Clinical Trial

Official title:
Study for Clinical Significance of Use of Alphafetoprotein (AFP), AFP-L3 and Des-gamma-carboxy Prothrombin (DCP) Versus US Alone in Surveillance for HCC

Clinical Trial Summary

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.

Clinical Trial Description

Data are being stored in the electric data capture (EDC) server. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01846949
Study type Observational
Source ALDUS Study Group
Contact
Status Enrolling by invitation
Phase
Start date May 2013
Completion date October 2022
View Details
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