- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT01355107
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
Přehled studie
Postavení
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Kontakty a umístění
Studijní místa
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Baden- Württemberg
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Freiburg, Baden- Württemberg, Německo, 79106
- University Medical Center Freiburg
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
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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
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chronic hcv, liver cirrhosis, no HCC
patients with hcv- associated cirrhosis of the liver, but with no HCC - suspected lesions in the liver
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hcv-infection, HCC
patients with hcv- associated HCC
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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measurement of selenium levels in hcv- infected patients
Časové okno: baseline
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measurement of selenium levels in whole blood samples
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baseline
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
selenium levels and inflammatory activity
Časové okno: baseline
|
determination if there is a correlation between selenium levels and inflammatory activity
|
baseline
|
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selenium levels and stage of HCC (BCLC, UICC)
Časové okno: baseline
|
determination if there is a correlation between selenium levels and the stage of HCC (BCLC, UICC)
|
baseline
|
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selenium levels and MELD(Na)score
Časové okno: baseline
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determination if there is a correlation between selenium levels and the MELD(Na)-score
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baseline
|
Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Publikace a užitečné odkazy
Obecné publikace
- 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.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Nemoci trávicího systému
- Patologické procesy
- RNA virové infekce
- Virová onemocnění
- Infekce
- Infekce přenášené krví
- Přenosné nemoci
- Novotvary podle histologického typu
- Novotvary
- Novotvary podle místa
- Adenokarcinom
- Karcinom
- Novotvary, žlázové a epiteliální
- Novotvary trávicího systému
- Onemocnění jater
- Infekce Flaviviridae
- Hepatitida, virová, lidská
- Novotvary jater
- Fibróza
- Hepatitida
- Karcinom, Hepatocelulární
- Hepatitida C
- Cirhóza jater
Další identifikační čísla studie
- HCC1
- DRKS00000813 (Identifikátor registru: German Clinical Trials Register)
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