CaNAL: Canadian Network for Autoimmune Liver Disease
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Observational There is no intervention being administered. This registry only observes patients through their regular standard of care visits. |
Other: Observational; no intervention
Observational; no intervention
|
Outcome Measures
Primary Outcome Measures
- Liver transplant-free survival over time [Up to 6 years or time of death/liver transplant]
Time-to-event
Secondary Outcome Measures
- Biochemical values over time (e.g. aspartate aminotransferase, alkaline phosphatase, alanine aminotransferase, Bilirubin) [Through study completion, an average of 6 months]
Investigate trends of different biochemical values over time
- Short Form 36 (SF-36) [Through study completion, an average of 6 months]
Health-Related Quality of Life
- PBC-40 [Through study completion, an average of 6 months]
Health-Related Quality of Life, specific to Primary Biliary Cholangitis
- 5D Pruritus Scale [Through study completion, an average of 6 months]
Itch-Related Quality of Life through 5 dimensions: duration, degree, direction, disability, and distribution. Each dimension is scored from 1(lowest) to 5(highest) for a total score range of 5-25
- Itch Visual Analog Scale [Through study completion, an average of 6 months]
Itch-Related Quality of Life; Continuous unitless itch scale from no itch to worst itch imaginable
- Itch Numeric Rating Scale [Through study completion, an average of 6 months]
Itch-Related Quality of Life; Categorical integer scale from 0 (no itch) to 10 (worst itch imaginable)
Eligibility Criteria
Criteria
Inclusion Criteria:
- Diagnosis of Primary Biliary Cholangitis and/or Autoimmune Hepatitis
Exclusion Criteria:
- Less than 18 years of age
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Foothills Medical Centre | Calgary | Alberta | Canada | T2N 2T9 |
| 2 | University of Alberta Hospital | Edmonton | Alberta | Canada | T6G 2B7 |
| 3 | Vancouver General Hospital | Vancouver | British Columbia | Canada | V5Z 1M9 |
| 4 | St. Paul's Hospital | Vancouver | British Columbia | Canada | V6Z 1Y6 |
| 5 | Health Sciences Centre | Winnipeg | Manitoba | Canada | R3A 1R9 |
| 6 | Queen Elizabeth II Health Sciences Centre | Halifax | Nova Scotia | Canada | B3H 2Y9 |
| 7 | McMaster University Medical Centre | Hamilton | Ontario | Canada | L8S 4K1 |
| 8 | Kingston Health Sciences Centre (HDH Site) | Kingston | Ontario | Canada | K7L 5G2 |
| 9 | London Health Sciences Centre - University Hospital | London | Ontario | Canada | N6A 5A5 |
| 10 | The Ottawa Hospital | Ottawa | Ontario | Canada | K1H 8L6 |
| 11 | Toronto General Hospital | Toronto | Ontario | Canada | M5G 2C4 |
| 12 | McMaster University Medical Centre | Montreal | Quebec | Canada | H4A 3J1 |
| 13 | Centre hospitalier de l'Université de Montréal | Montréal | Quebec | Canada | H2X 0A9 |
| 14 | Université de Sherbrooke | Sherbrooke | Quebec | Canada | J1G2E8 |
| 15 | Royal University Hospital | Saskatoon | Saskatchewan | Canada | S7N 0W8 |
Sponsors and Collaborators
- University Health Network, Toronto
Investigators
- Principal Investigator: Bettina Hansen, PhD, University Health Network, Toronto General Hospital
- Principal Investigator: Andrew Mason, MD, University of Alberta
Study Documents (Full-Text)
More Information
Publications
None provided.- CAPCR ID: 18-5951