Comparison of Selenium Levels in HCV- Infected Patients at Different Stages of Disease
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01355107|
Recruitment Status : Completed
First Posted : May 17, 2011
Last Update Posted : December 14, 2011
|Condition or disease|
|Hepatitis C Liver Cirrhosis Carcinoma, Hepatocellular|
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.
|Study Type :||Observational|
|Actual Enrollment :||32 participants|
|Observational Model:||Case Control|
|Official Title:||Comparison of Selenium Levels in HCV- Infected Patients at Different Stages of Disease - a Pilot Trial|
|Study Start Date :||April 2011|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||December 2011|
chronic hcv, no liver cirrhosis, no HCC
patients with chronic hepatitis c- infection: no cirrhosis of the liver (= Desmet IV), no HCC - suspected lesion in the liver
chronic hcv, liver cirrhosis, no HCC
patients with hcv- associated cirrhosis of the liver, but with no HCC - suspected lesions in the liver
patients with hcv- associated HCC
- measurement of selenium levels in hcv- infected patients [ Time Frame: baseline ]measurement of selenium levels in whole blood samples
- selenium levels and inflammatory activity [ Time Frame: baseline ]determination if there is a correlation between selenium levels and inflammatory activity
- selenium levels and stage of HCC (BCLC, UICC) [ Time Frame: baseline ]determination if there is a correlation between selenium levels and the stage of HCC (BCLC, UICC)
- selenium levels and MELD(Na)score [ Time Frame: baseline ]determination if there is a correlation between selenium levels and the MELD(Na)-score
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01355107
|University Medical Center Freiburg|
|Freiburg, Baden- Württemberg, Germany, 79106|
|Principal Investigator:||Hans Christian Spangenberg, Prof. Dr.||University Medical Center Freiburg|