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

NCT01355107 | Completed

• 2 other identifiers: HCC1DRKS00000813
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis C; Liver Cirrhosis; Carcinoma, Hepatocellular

Keywords

selenium level measurement

Outcome Measures

Primary Outcomes (1)

• measurement of selenium levels in hcv- infected patients

  measurement of selenium levels in whole blood samples

  baseline

Secondary Outcomes (3)

• selenium levels and inflammatory activity

  baseline

• selenium levels and stage of HCC (BCLC, UICC)

  baseline

• selenium levels and MELD(Na)score

  baseline

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Freiburg: lead
• Biosyn: collaborator

Study Sites (1)

University Medical Center Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

Location

Related Publications (9)

• Muecke R, Schomburg L, Buentzel J, Kisters K, Micke O; German Working Group Trace Elements and Electrolytes in Oncology. Selenium or no selenium--that is the question in tumor patients: a new controversy. Integr Cancer Ther. 2010 Jun;9(2):136-41. doi: 10.1177/1534735410367648. Epub 2010 May 11.

  PMID: 20462857 BACKGROUND

• Brenneisen P, Steinbrenner H, Sies H. Selenium, oxidative stress, and health aspects. Mol Aspects Med. 2005 Aug-Oct;26(4-5):256-67. doi: 10.1016/j.mam.2005.07.004.

  PMID: 16105679 BACKGROUND

• Shamberger RJ, Rukovena E, Longfield AK, Tytko SA, Deodhar S, Willis CE. Antioxidants and cancer. I. Selenium in the blood of normals and cancer patients. J Natl Cancer Inst. 1973 Apr;50(4):863-70. doi: 10.1093/jnci/50.4.863. No abstract available.

  PMID: 4703775 BACKGROUND

• Sakoda LC, Graubard BI, Evans AA, London WT, Lin WY, Shen FM, McGlynn KA. Toenail selenium and risk of hepatocellular carcinoma mortality in Haimen City, China. Int J Cancer. 2005 Jul 1;115(4):618-24. doi: 10.1002/ijc.20937.

  PMID: 15704105 BACKGROUND

• Yu MW, Horng IS, Hsu KH, Chiang YC, Liaw YF, Chen CJ. Plasma selenium levels and risk of hepatocellular carcinoma among men with chronic hepatitis virus infection. Am J Epidemiol. 1999 Aug 15;150(4):367-74. doi: 10.1093/oxfordjournals.aje.a010016.

  PMID: 10453813 BACKGROUND

• Yu SY, Zhu YJ, Li WG, Huang QS, Huang CZ, Zhang QN, Hou C. A preliminary report on the intervention trials of primary liver cancer in high-risk populations with nutritional supplementation of selenium in China. Biol Trace Elem Res. 1991 Jun;29(3):289-94. doi: 10.1007/BF03032685.

  PMID: 1726411 BACKGROUND

• Lin CC, Huang JF, Tsai LY, Huang YL. Selenium, iron, copper, and zinc levels and copper-to-zinc ratios in serum of patients at different stages of viral hepatic diseases. Biol Trace Elem Res. 2006 Jan;109(1):15-24. doi: 10.1385/BTER:109:1:015.

  PMID: 16388099 BACKGROUND

• Navarro-Alarcon M, Lopez-Ga de la Serrana H, Perez-Valero V, Lopez-Martinez MC. Selenium concentrations in serum of individuals with liver diseases (cirrhosis or hepatitis): relationship with some nutritional and biochemical markers. Sci Total Environ. 2002 May 27;291(1-3):135-41. doi: 10.1016/s0048-9697(01)01088-9.

  PMID: 12150433 BACKGROUND

• Martinez-Peinado M, Nogueras-Lopez F, Arcos-Cebrian A, Agil A, Navarro-Alarcon M. Serum selenium levels in cirrhotic patients are not influenced by the disease severity index. Nutr Res. 2010 Aug;30(8):574-8. doi: 10.1016/j.nutres.2010.08.004.

  PMID: 20851312 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

whole blood

MeSH Terms

Conditions

Hepatitis C; Liver Cirrhosis; Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site

Study Officials

• Hans Christian Spangenberg, Prof. Dr.

  University Medical Center Freiburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: investigator

Study Record Dates

• First Submitted: May 6, 2011
• First Posted: May 17, 2011
• Study Start: April 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: December 14, 2011

Record last verified: 2011-12

Locations

DE (1)