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
研究概览
详细说明
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.
研究类型
注册 (实际的)
联系人和位置
学习地点
-
-
Baden- Württemberg
-
Freiburg、Baden- Württemberg、德国、79106
- University Medical Center Freiburg
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
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
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
---|
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
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
measurement of selenium levels in hcv- infected patients
大体时间:baseline
|
measurement of selenium levels in whole blood samples
|
baseline
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
selenium levels and inflammatory activity
大体时间:baseline
|
determination if there is a correlation between selenium levels and inflammatory activity
|
baseline
|
selenium levels and stage of HCC (BCLC, UICC)
大体时间:baseline
|
determination if there is a correlation between selenium levels and the stage of HCC (BCLC, UICC)
|
baseline
|
selenium levels and MELD(Na)score
大体时间:baseline
|
determination if there is a correlation between selenium levels and the MELD(Na)-score
|
baseline
|
合作者和调查者
出版物和有用的链接
一般刊物
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.