Canadian Network for Autoimmune Liver Disease

Recruiting now

Conditions studied: Primary Bilary Cirrhosis (PBC), Autoimmune Hepatitis, Overlap Syndrome

In brief

CaNAL is a longitudinal observational cohort study of patients diagnosed with Primary Biliary Cholangitis (PBC), Autoimmune Hepatitis (AIH), or overlap syndrome. This study creates a nationwide registry and network focusing on high quality long-term follow-up of individual patient data from major Canadian centers. Primary Biliary Cholangitis (PBC) and Autoimmune Hepatitis (AIH) are rare and slowly progressive liver diseases associated with development of cirrhosis, liver cancer (HCC) and liver failure requiring liver transplantation or leading to premature death. The rarity and slowly progressive nature of these autoimmune liver diseases make them difficult to study and only a large scale approach combining patient data from multiple centers across Canada will allow new insights. The primary aim of the Canadian Network for Autoimmune Liver Disease is to build a Canadian registry of patients with PBC, AIH, and overlap syndrome. We capture patient characteristics, laboratory assessments and natural history, patient-reported outcomes including quality of life measures and environmental exposures, response to treatment, and pre- and post-transplant outcomes. We will then identify risk factors associated with critical outcomes for the patient, including response to treatment, progression to transplant, risk of liver cancer, and recurrent disease after transplant. We can identify biomarkers (biochemical indicators of progression of disease) to help diagnose autoimmune liver disease at its earliest stages, ensuring timely treatment and preventing disease progression. CaNAL will provide a better understanding of autoimmune liver diseases, biomarkers predictive of disease progression or non-response to therapy as well as better knowledge of the etiology and pathogenesis. CaNAL will also help to serve as a platform for conducting clinical trials or targeted lab-studies to answer important questions that are unlikely to be evaluated by the pharmaceutical industry.

Key facts

Study ID

NCT03569826

Run by

University Health Network, Toronto

People needed

2500

Starts

2018-02-07

Expected to finish

2028-12-01

Last updated by the study team

2021-06-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of Primary Biliary Cholangitis and/or Autoimmune Hepatitis

You may not qualify if…

• Less than 18 years of age

Where it is running

• London Health Sciences Centre - University Hospital — London, Ontario, Canada (enrolling)
• The Ottawa Hospital — Ottawa, Ontario, Canada (enrolling)
• Toronto General Hospital — Toronto, Ontario, Canada (enrolling)
• Centre hospitalier de l'Université de Montréal — Montreal, Quebec, Canada (enrolling)
• University of Alberta Hospital — Edmonton, Alberta, Canada (enrolling)
• Université de Sherbrooke — Sherbrooke, Quebec, Canada (enrolling)
• Royal University Hospital — Saskatoon, Saskatchewan, Canada (enrolling)
• McMaster University Medical Centre — Montreal, Quebec, Canada
• Kingston Health Sciences Centre (HDH Site) — Kingston, Ontario, Canada
• Vancouver General Hospital — Vancouver, British Columbia, Canada
• St. Paul's Hospital — Vancouver, British Columbia, Canada
• Health Sciences Centre — Winnipeg, Manitoba, Canada
• Queen Elizabeth II Health Sciences Centre — Halifax, Nova Scotia, Canada
• McMaster University Medical Centre — Hamilton, Ontario, Canada
• Foothills Medical Centre — Calgary, Alberta, Canada

Full record on ClinicalTrials.gov

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