Within the Program for public-private collaborations for Research, Innovation and Health Technology Assessment (PRIHTA), Regione Veneto has approved a health technology assessment (HTA) project on Hepa-IC submitted by Xeptagen, the Department of Medicine - University of Padua and the regional center for diagnostic, prognostic and predictive biomarkers (CRIBT) of ULSS 12 in Venice. The aim of the project is to determine the cost-effectiveness and cost-benefit of using SCCA-IgM serological levels to monitor cirrhotic patients at risk of hepatocellular carcinoma (HCC).
HCC is a malignant tumor of the liver with a high mortality rate. However, if diagnosed early, the cancer can be treated and survival of the patient increases. The major risk factor for HCC is cirrhosis, a hepatic disease that is caused mainly by infection with hepatitis viruses, alcohol abuse or metabolic syndrome with steatohepatitis.
European guidelines call for regular monitoring of cirrhotic patients with ultrasounds (US) to detect HCC, but this examination is operator-dependent and is not sensitive enough to identify early liver cancer.