Canadian Network for Autoimmune Liver Disease (CaNAL)

  • STATUS
    Recruiting
  • End date
    Dec 14, 2028
  • participants needed
    2500
  • sponsor
    University Health Network, Toronto
Updated on 4 March 2022
liver cancer
cancer
hepatitis
liver disease
liver transplant
cirrhosis
liver failure
recurrent disease
overlap syndrome
cholangitis

Summary

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.

Details
Condition Primary Bilary Cirrhosis (PBC), Autoimmune Hepatitis, Overlap Syndrome
Treatment Observational; no intervention
Clinical Study IdentifierNCT03569826
SponsorUniversity Health Network, Toronto
Last Modified on4 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Diagnosis of Primary Biliary Cholangitis and/or Autoimmune Hepatitis

Exclusion Criteria

Less than 18 years of age
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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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