University Medical Center Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany
NCT Number: NCT01355107
The incidence of hepatocellular carcinoma (HCC) is rising worldwide.One important etiology is a chronic inflammation due to hepatitis c (hcv) infection. Over the steps of a chronic inflammation over the stadium of cirrhosis of the liver it is possible that neoplastic nodules appear in the liver which can rise up to a HCC. In the pathogenesis of HCC oxidative stress seems to play an important role and as selenium is a key micronutrient in this process its levels could differ between the different stages of disease in hcv- infected patients. The aim of this trial is to examine these differences.
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Notify Me18 year–80 year
Male
Observational
Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: baseline
measurement of selenium levels in whole blood samples
Time frame: baseline
determination if there is a correlation between selenium levels and inflammatory activity
Time frame: baseline
determination if there is a correlation between selenium levels and the stage of HCC (BCLC, UICC)
Time frame: baseline
determination if there is a correlation between selenium levels and the MELD(Na)-score
University Hospital Freiburg
Other
Comparison of Selenium Levels in HCV- Infected Patients at Different Stages of Disease - a Pilot Trial
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