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- Essai clinique 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
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Baden- Württemberg
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Freiburg, Baden- Württemberg, Allemagne, 79106
- University Medical Center Freiburg
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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measurement of selenium levels in hcv- infected patients
Délai: baseline
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measurement of selenium levels in whole blood samples
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baseline
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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selenium levels and inflammatory activity
Délai: baseline
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determination if there is a correlation between selenium levels and inflammatory activity
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baseline
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selenium levels and stage of HCC (BCLC, UICC)
Délai: baseline
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determination if there is a correlation between selenium levels and the stage of HCC (BCLC, UICC)
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baseline
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selenium levels and MELD(Na)score
Délai: baseline
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determination if there is a correlation between selenium levels and the MELD(Na)-score
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baseline
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Maladies du système digestif
- Processus pathologiques
- Infections par virus à ARN
- Maladies virales
- Infections
- Infections transmissibles par le sang
- Maladies transmissibles
- Tumeurs par type histologique
- Tumeurs
- Tumeurs par site
- Adénocarcinome
- Carcinome
- Tumeurs, glandulaires et épithéliales
- Tumeurs du système digestif
- Maladies du foie
- Infections à Flaviviridae
- Hépatite, virale, humaine
- Tumeurs du foie
- Fibrose
- Hépatite
- Carcinome hépatocellulaire
- Hépatite C
- La cirrhose du foie
Autres numéros d'identification d'étude
- HCC1
- DRKS00000813 (Identificateur de registre: German Clinical Trials Register)
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