Trial Information

Comparison of Selenium Levels in HCV- Infected Patients at Different Stages of Disease - a Pilot Trial

The incidence of hepatocellular carcinoma (HCC) is rising worldwide. Almost all cases of HCC
develop over clearly defined stages of chronic hepatic inflammation and cirrhosis of the
liver which can be determined as an irreversible stage during this process. In the Western
world excessive alcohol consumption and chronic infection with the hepatitis c virus (hcv)
are frequent causes of chronic hepatocellular injury. As HCC is often diagnosed at advanced
stages and therapeutic intervention possibilities are limited it becomes more and more
necessary to search for prevention strategies to stop the development of HCC.

In the last years micronutrients such as selenium have reached the interests of oncologists.
Several studies were able to show that there are often low selenium levels in patients with
different tumors. Some epidemiologic studies showed that supplementation of selenium can
decrease the incidence of some tumors.

Oxidative stress is meant to play an essential role in hepatocarcinogenesis and as selenium
could decrease it, it may be possible that patients infected with the hepatitis c - virus
show low selenium levels probably as a result of the chronic hepatic inflammation. Moreover
there may be differences between the stages of disease namely chronic infection, cirrhosis
of the liver and hepatocellular carcinoma. The aim of this trial is to determine these
differences.

HCV- infected patients are enrolled in this trial. Three groups are formed: In Group 1 all
HCV- infected patients with a chronic inflammation without cirrhosis of the liver and
without HCC are summarized. in group 2 all HCV- infected patients with cirrhosis of the
liver but without HCC are enrolled. In group 3 hcv- infected HCC- patients are summarized.
In each group 10 patients should be enrolled, matched to age and other diseases. Blood
samples are taken from these patients and selenium levels are measured.