NCT03569826 Canadian Network for Autoimmune Liver Disease
| NCT ID | NCT03569826 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Health Network, Toronto |
| Condition | Primary Bilary Cirrhosis (PBC) |
| Study Type | OBSERVATIONAL |
| Enrollment | 2,500 participants |
| Start Date | 2018-02-07 |
| Primary Completion | 2028-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 2,500 participants in total. It began in 2018-02-07 with a primary completion date of 2028-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * Diagnosis of Primary Biliary Cholangitis and/or Autoimmune Hepatitis Exclusion Criteria: * Less than 18 years of age
Contact & Investigator
Bettina Hansen, PhD
PRINCIPAL INVESTIGATOR
University Health Network, Toronto General Hospital
Frequently Asked Questions
Who can join the NCT03569826 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Primary Bilary Cirrhosis (PBC). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03569826 currently recruiting?
Yes, NCT03569826 is actively recruiting participants. Contact the research team at surain.roberts@uhn.ca for enrollment information.
Where is the NCT03569826 trial being conducted?
This trial is being conducted at Calgary, Canada, Edmonton, Canada, Vancouver, Canada, Vancouver, Canada and 11 additional locations.
Who is sponsoring the NCT03569826 clinical trial?
NCT03569826 is sponsored by University Health Network, Toronto. The principal investigator is Bettina Hansen, PhD at University Health Network, Toronto General Hospital. The trial plans to enroll 2,500 participants.