Canadian Network for Autoimmune Liver Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Observational; no intervention.
- Who it may be relevant to
- Registry conditions: Primary Bilary Cirrhosis (PBC), Autoimmune Hepatitis, Overlap Syndrome. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Other Observational; no intervention
Observational; no intervention
Primary outcome measures
- Liver transplant-free survival over time [Time frame: Up to 6 years or time of death/liver transplant]
Secondary outcome measures (6)
- Biochemical values over time (e.g. aspartate aminotransferase, alkaline phosphatase, alanine aminotransferase, Bilirubin) [Time frame: Through study completion, an average of 6 months]
- Short Form 36 (SF-36) [Time frame: Through study completion, an average of 6 months]
- PBC-40 [Time frame: Through study completion, an average of 6 months]
- 5D Pruritus Scale [Time frame: Through study completion, an average of 6 months]
- Itch Visual Analog Scale [Time frame: Through study completion, an average of 6 months]
- Itch Numeric Rating Scale [Time frame: Through study completion, an average of 6 months]
Eligibility criteria
Inclusion criteria
- Diagnosis of Primary Biliary Cholangitis and/or Autoimmune Hepatitis
Exclusion criteria
- Less than 18 years of age
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Canada · 15 centers
- Foothills Medical Centre — Calgary
- University of Alberta Hospital — Edmonton
- Vancouver General Hospital — Vancouver
- St. Paul's Hospital — Vancouver
- Health Sciences Centre — Winnipeg
- Queen Elizabeth II Health Sciences Centre — Halifax
- McMaster University Medical Centre — Hamilton
- Kingston Health Sciences Centre (HDH Site) — Kingston
- … and 7 more centers
Identifiers
NCT: NCT03569826 · CAPCR ID: 18-5951