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Sponsored by: |
University Health Network, Toronto |
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Information provided by: | University Health Network, Toronto |
ClinicalTrials.gov Identifier: | NCT00160940 |
The purpose of this research is to study body materials like blood proteins as well as white blood cell and liver cellular RNA in individuals with liver diseases such as chronic viral hepatitis with or without hepatoma and autoimmune liver disease. Presently it is not understood how infection with chronic viral hepatitis or autoimmune liver disease damages the liver. This research study enroll patients with either chronic viral hepatitis with or without hepatoma or autoimmune liver disease.
The purpose of this study is to find the genes that are expressed in both the circulating white blood cells and the liver of patients with varying degrees of liver damage of different causes. Genes are biological messengers some of which determine how the body responds to injury. We anticipate that results from Differential Gene Expression (DGE) analysis will allow us to make predictions about likelihood of disease progression and/or response to treatment.
In addition we will test the blood for markers of injury. The blood collected will be prepared differently from the liver tissue. We will use technologies to express pure proteins and then we will investigate the functions of these proteins. Nearly all drugs act on proteins, not genes, so understanding proteins is the key to really effective new medicines. Similarly the first signs of ill health appear in changes to the body’s blood proteins, making them the most sensitive diagnostic indicators. The studies we plan are called proteomics.
We will later correlate the patterns of gene expression in both circulating white blood cells and the liver tissue with clinical outcome and patterns of proteins measured in blood and we hope to gain an understanding of how the disease process occurs, which may in turn help us to make more precise diagnoses and develop new forms of treatment.
These techniques that we use are still experimental and so we do not yet know if they will be helpful in monitoring changes which may help us to predict the potential severity of your liver disease or even if they can be used to indicate who will best respond to treatment.
Condition |
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Hepatitis C Hepatitis B Autoimmune Hepatitis Liver Cirrhosis, Biliary Cholangitis, Sclerosing |
Study Type: | Observational |
Study Design: | Cross-Sectional, Defined Population, Prospective Study |
Official Title: | Differential Gene Expression in Liver Tissue and Blood From Individuals With Chronic Viral Hepatitis With or Without a Complicating Hepatoma or Autoimmune Liver Disease |
Ages Eligible for Study: | 18 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria: patients who have a liver biopsy as standard of care and are diagnosed with either:
Exclusion Criteria:
Contact: Catalina Coltescu | 416-603-5832 |
Canada, Ontario | |
Liver Clinic, Toronto Western Hospital, UHN | Recruiting |
Toronto, Ontario, Canada | |
Contact: E.J.L. (Jenny) Heathcote, MD 416-603-5914 | |
Principal Investigator: E.J.L. (Jenny) Heathcote, MD |
Principal Investigator: | E.J.L (Jenny) Heathcote, MD | UHN - Toronto Western Hospital, University of Toronto |
Study ID Numbers: | 02-0019-C |
Study First Received: | September 8, 2005 |
Last Updated: | November 29, 2005 |
ClinicalTrials.gov Identifier: | NCT00160940 |
Health Authority: | Canada: Health Canada |
gene expression viral hepatitis autoimmune disease |
Liver Diseases Autoimmune Diseases Hepatitis, Chronic Cholangitis, Sclerosing Cholestasis Fibrosis Liver neoplasms Hepatitis, Viral, Human Liver Cirrhosis Autoimmune hepatitis Hepatitis, Autoimmune Virus Diseases |
Liver Neoplasms Hepatitis Cholangitis Cholestasis, Intrahepatic Digestive System Diseases Bile Duct Diseases Biliary Tract Diseases Hepatitis B DNA Virus Infections Hepatitis C Liver Cirrhosis, Biliary Hepatocellular carcinoma |
RNA Virus Infections Pathologic Processes Immune System Diseases Flaviviridae Infections Hepadnaviridae Infections |