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

18 Years
80 Years
Not Enrolling
Hepatitis C, Liver Cirrhosis, Carcinoma, Hepatocellular

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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

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.

Inclusion Criteria:

- patients with chronic hepatitis c- infection: no cirrhosis of the liver (= Desmet
IV), no HCC - suspected lesion in the liver

- patients with hcv- associated cirrhosis of the liver: - cirrhosis of the liver
confirmed by ultrasound, CT/MRI imaging or biopsy, all child - stages

- patients with hcv- associated HCC: diagnosis of HCC according to the AASLD criteria,
HCC has not been treated at the time of enrollment, all BCLC- /UICC- stages.

- for all three groups: diagnosis of the chronic hcv- infection with virus rna and
serologic parameters (anti-hcv) and abnormal liver function for more than 6 months,
no antiviral treatment during the last 6 months

Exclusion Criteria:

- application of dietary supplements

- excessive alcohol consumption

- all other etiologies leading to a liver injury

- patients with an acute-phase- reaction, SIRS or patients in intensive care units

- extrahepatic neoplasm

- rheumatic disease apart from hcv- associated immunologic phenomena

- diabetes mellitus I and II

- immunological diseases

Type of Study:


Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome Measure:

measurement of selenium levels in hcv- infected patients

Outcome Description:

measurement of selenium levels in whole blood samples

Outcome Time Frame:


Safety Issue:


Principal Investigator

Hans Christian Spangenberg, Prof. Dr.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Medical Center Freiburg


Germany: Ethics Commission

Study ID:




Start Date:

April 2011

Completion Date:

December 2011

Related Keywords:

  • Hepatitis C
  • Liver Cirrhosis
  • Carcinoma, Hepatocellular
  • selenium level measurement
  • Carcinoma
  • Hepatitis
  • Hepatitis A
  • Hepatitis C
  • Liver Cirrhosis
  • Fibrosis
  • Carcinoma, Hepatocellular