Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Hepatocellular | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Hepatitis C | — | UNRESOLVED | — |
| Liver Cirrhosis | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (3)
- label
- chronic hcv, no liver cirrhosis, no HCC
- description
- patients with chronic hepatitis c- infection: no cirrhosis of the liver (= Desmet IV), no HCC - suspected lesion in the liver
- label
- chronic hcv, liver cirrhosis, no HCC
- description
- patients with hcv- associated cirrhosis of the liver, but with no HCC - suspected lesions in the liver
- label
- hcv-infection, HCC
- description
- patients with hcv- associated HCC
Primary outcomes (1)
- measure
- measurement of selenium levels in hcv- infected patients
- timeFrame
- baseline
- description
- measurement of selenium levels in whole blood samples
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (9)
- BACKGROUNDMuecke 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
- BACKGROUNDBrenneisen 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
- BACKGROUNDShamberger 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
- BACKGROUNDSakoda 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
- BACKGROUNDYu 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
- BACKGROUNDYu 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
- BACKGROUNDLin 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.