Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
2500 participants
OBSERVATIONAL
2018-02-07
2028-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
OTHER
Study Groups
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Observational
There is no intervention being administered. This registry only observes patients through their regular standard of care visits.
Observational; no intervention
Observational; no intervention
Interventions
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Observational; no intervention
Observational; no intervention
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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University Health Network, Toronto
OTHER
Responsible Party
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Principal Investigators
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Bettina Hansen, PhD
Role: PRINCIPAL_INVESTIGATOR
University Health Network, Toronto General Hospital
Andrew Mason, MD
Role: PRINCIPAL_INVESTIGATOR
University of Alberta
Locations
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Foothills Medical Centre
Calgary, Alberta, Canada
University of Alberta Hospital
Edmonton, Alberta, 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
Kingston Health Sciences Centre (HDH Site)
Kingston, Ontario, Canada
London Health Sciences Centre - University Hospital
London, Ontario, Canada
The Ottawa Hospital
Ottawa, Ontario, Canada
Toronto General Hospital
Toronto, Ontario, Canada
Centre hospitalier de l'Université de Montréal
Montreal, Quebec, Canada
McMaster University Medical Centre
Montreal, Quebec, Canada
Université de Sherbrooke
Sherbrooke, Quebec, Canada
Royal University Hospital
Saskatoon, Saskatchewan, Canada
Countries
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Central Contacts
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Facility Contacts
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Hin Hin Ko, MD
Role: primary
Marco Puglia, MD
Role: primary
Marc Deschenes
Role: primary
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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CAPCR ID: 18-5951
Identifier Type: -
Identifier Source: org_study_id
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