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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by University Health Network, Toronto.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00160940
First received: September 8, 2005
Last updated: November 29, 2005
Last verified: September 2005
  Purpose

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

Study Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Cross-Sectional
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

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Estimated Enrollment: 200
Study Start Date: February 2002
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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:

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00160940

Contacts
Contact: Catalina Coltescu 416-603-5832

Locations
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
Investigators
Principal Investigator: E.J.L (Jenny) Heathcote, MD UHN - Toronto Western Hospital, University of Toronto
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00160940     History of Changes
Other Study ID Numbers: 02-0019-C
Study First Received: September 8, 2005
Last Updated: November 29, 2005
Health Authority: Canada: Health Canada

Keywords provided by University Health Network, Toronto:
gene expression
viral hepatitis
autoimmune disease

Additional relevant MeSH terms:
Liver Cirrhosis, Biliary
Cholangitis
Cholangitis, Sclerosing
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis C
Hepatitis, Autoimmune
Liver Cirrhosis
Autoimmune Diseases
Bile Duct Diseases
Biliary Tract Diseases
Cholestasis
Cholestasis, Intrahepatic
Digestive System Diseases
DNA Virus Infections
Enterovirus Infections
Flaviviridae Infections
Hepadnaviridae Infections
Hepatitis, Chronic
Hepatitis, Viral, Human
Immune System Diseases
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on October 30, 2014