Working… Menu

Differential Gene Expression of Liver Tissue and Blood From Individuals With Chronic Viral Hepatitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00160940
Recruitment Status : Unknown
Verified September 2005 by University Health Network, Toronto.
Recruitment status was:  Recruiting
First Posted : September 12, 2005
Last Update Posted : December 1, 2005
Information provided by:
University Health Network, Toronto

Brief Summary:

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 or disease
Hepatitis C Hepatitis B Autoimmune Hepatitis Liver Cirrhosis, Biliary Cholangitis, Sclerosing

Show Show detailed description

Layout table for study information
Study Type : Observational
Enrollment : 200 participants
Observational Model: Defined Population
Time Perspective: Other
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
Study Start Date : February 2002

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria: patients who have a liver biopsy as standard of care and are diagnosed with either:

  • patients attending Liver Clinic at Toronto Western Hospital, Toronto, ON, Canada
  • Hepatitis C
  • Hepatitis B
  • Autoimmune Hepatitis
  • Primary Biliary Cirrhosis
  • Primary Sclerosing Cholangitis

Exclusion Criteria:

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00160940

Layout table for location contacts
Contact: Catalina Coltescu 416-603-5832

Layout table for location information
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         
Sponsors and Collaborators
University Health Network, Toronto
Layout table for investigator information
Principal Investigator: E.J.L (Jenny) Heathcote, MD UHN - Toronto Western Hospital, University of Toronto
Layout table for additonal information Identifier: NCT00160940    
Other Study ID Numbers: 02-0019-C
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: December 1, 2005
Last Verified: September 2005
Keywords provided by University Health Network, Toronto:
gene expression
viral hepatitis
autoimmune disease
Additional relevant MeSH terms:
Layout table for MeSH terms
Hepatitis A
Hepatitis C
Hepatitis B
Liver Cirrhosis
Hepatitis, Autoimmune
Liver Cirrhosis, Biliary
Cholangitis, Sclerosing
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hepadnaviridae Infections
DNA Virus Infections
Bile Duct Diseases
Biliary Tract Diseases
Hepatitis, Chronic
Autoimmune Diseases
Immune System Diseases
Cholestasis, Intrahepatic