Clinical trial NCT01355107: Comparison of Selenium Levels in HCV- Infected Patients at Different Stages of Disease
Official title: Comparison of Selenium Levels in HCV- Infected Patients at Different Stages of Disease - a Pilot Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C
Liver Cirrhosis
Carcinoma, Hepatocellular
Keywords: selenium level measurement
Lead sponsor: University Hospital Freiburg
Sponsor class: OTHER
Collaborators: name: Biosyn
First posted: 2011-05-17
Enrollment: 32
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Whole blood samples are taken from inpatients and outpatients of our primary care clinic

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: measurement of selenium levels in hcv- infected patients
timeFrame: baseline
Secondary outcomes:
measure: selenium levels and inflammatory activity
timeFrame: baseline
measure: selenium levels and stage of HCC (BCLC, UICC)
timeFrame: baseline
measure: selenium levels and MELD(Na)score
timeFrame: baseline
Other outcomes:
Locations:
city: Freiburg
country: Germany
facility: University Medical Center Freiburg
state: Baden- Württemberg
Study officials:
affiliation: University Medical Center Freiburg
name: Hans Christian Spangenberg, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
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