Recruiting

Observational Study

Sponsor:

University Health Network, Toronto

Code:

NCT00242125

Conditions

Biliary Cirrhosis, Primary

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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.

Conditions

Biliary Cirrhosis, Primary

Study ID

NCT00242125

Start date

Oct, 2005

Status verified date

Oct, 2005

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

3000 participants

Interventions and Outcome Measures

Central Contacts and Locations

Central contacts

Catalina Coltescu

416-603-5832

Locations

Liver Clinic, Toronto Western Hospital, UHN

Recruiting

Toronto, Ontario, Canada, M5T 2S8

Contacts

Jenny (E.J.L.) Heathcote, MD

416-603-5914

Principal Investigator:

E.J.L. (Jenny) Heathcote, MD

More Information

Sponsor

University Health Network, Toronto

Last update posted

Jan 16, 2006

Last verified

Oct, 2005

Keywords

  • Primary biliary Cirrhosis
  • genes
  • DNA

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2006-01-16.