Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Collaborator:
Biosyn
Information provided by (Responsible Party):
Dominik Bettinger, University Hospital Freiburg
ClinicalTrials.gov Identifier:
NCT01355107
First received: May 6, 2011
Last updated: December 13, 2011
Last verified: December 2011

May 6, 2011
December 13, 2011
April 2011
December 2011   (final data collection date for primary outcome measure)
measurement of selenium levels in hcv- infected patients [ Time Frame: baseline ] [ Designated as safety issue: No ]
measurement of selenium levels in whole blood samples
Same as current
Complete list of historical versions of study NCT01355107 on ClinicalTrials.gov Archive Site
  • selenium levels and inflammatory activity [ Time Frame: baseline ] [ Designated as safety issue: No ]
    determination if there is a correlation between selenium levels and inflammatory activity
  • selenium levels and stage of HCC (BCLC, UICC) [ Time Frame: baseline ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    determination if there is a correlation between selenium levels and the MELD(Na)-score
Same as current
Not Provided
Not Provided
 
Comparison of Selenium Levels in HCV- Infected Patients at Different Stages of Disease
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.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.

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

whole blood

Non-Probability Sample

Whole blood samples are taken from inpatients and outpatients of our primary care clinic

  • Hepatitis C
  • Liver Cirrhosis
  • Carcinoma, Hepatocellular
Not Provided
  • 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
  • hcv-infection, HCC
    patients with hcv- associated HCC

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
December 2011
December 2011   (final data collection date for primary outcome measure)

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
Male
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01355107
HCC1, DRKS00000813
No
Dominik Bettinger, University Hospital Freiburg
University Hospital Freiburg
Biosyn
Principal Investigator: Hans Christian Spangenberg, Prof. Dr. University Medical Center Freiburg
University Hospital Freiburg
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP