Family Studies in Primary Biliary Cirrhosis (PBC)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2005 by University Health Network, Toronto.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00242125
First received: October 18, 2005
Last updated: January 13, 2006
Last verified: October 2005
  Purpose

Primary biliary cirrhosis (PBC) is a chronic liver disease primarily affecting middle age women. It is characterized by immune-mediated damage to cells lining the tiny bile ducts within the liver. Although the underlying cause of PBC is likely to be multifactorial, the epidemiologic/population data indicate a very important role for genetic predisposition, meaning that the disease seems to run in families. Susceptibility genes for PBC have not been identified possibly due to limitations such as small sample size in prior studies. The primary objective of this study is to identify these genes. This study involves obtaining clinical and demographic data as well as collecting DNA samples from patients and their parents, and siblings to screen for a select set of candidate genes as well as the full genome for variants associated with PBC.


Condition
Biliary Cirrhosis, Primary

Study Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Cross-Sectional
Official Title: Family Studies in Primary Biliary Cirrhosis

Resource links provided by NLM:


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

Estimated Enrollment: 3000
Study Start Date: October 2005
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients attending Liver Clinic at Toronto Western Hospital, Toronto, ON, Canada
  • Diagnosis of PBC
  • Liver biopsy
  • Antimitochondrial antibody (AMA) positive
  • Elevated alkaline phosphatase (ALP)
  • Parents and siblings and controls (friends and spouses of propositi)
  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: NCT00242125

Contacts
Contact: Catalina Coltescu 416-603-5832

Locations
Canada, Ontario
Liver Clinic, Toronto Western Hospital, UHN Recruiting
Toronto, Ontario, Canada, M5T 2S8
Contact: Jenny (E.J.L.) 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 by University Health Network, Toronto

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00242125     History of Changes
Other Study ID Numbers: 05-0630-AE, MOP - 74621
Study First Received: October 18, 2005
Last Updated: January 13, 2006
Health Authority: Canada: Health Canada

Keywords provided by University Health Network, Toronto:
Primary biliary Cirrhosis
genes
DNA

Additional relevant MeSH terms:
Liver Cirrhosis, Biliary
Liver Cirrhosis
Fibrosis
Cholestasis, Intrahepatic
Cholestasis
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Liver Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 28, 2014