NCT00160940

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2002

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
Last Updated

December 1, 2005

Status Verified

September 1, 2005

First QC Date

September 8, 2005

Last Update Submit

November 29, 2005

Conditions

Keywords

gene expressionviral hepatitisautoimmune disease

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Liver Clinic, Toronto Western Hospital, UHN

Toronto, Ontario, Canada

RECRUITING

MeSH Terms

Conditions

Hepatitis CHepatitis BHepatitis, AutoimmuneLiver Cirrhosis, BiliaryCholangitis, SclerosingAutoimmune Diseases

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System DiseasesHepadnaviridae InfectionsDNA Virus InfectionsHepatitis, ChronicImmune System DiseasesCholestasis, IntrahepaticCholestasisBile Duct DiseasesBiliary Tract DiseasesLiver CirrhosisFibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsCholangitis

Study Officials

  • E.J.L (Jenny) Heathcote, MD

    UHN - Toronto Western Hospital, University of Toronto

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Catalina Coltescu

CONTACT

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
OTHER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

February 1, 2002

Last Updated

December 1, 2005

Record last verified: 2005-09

Locations