Canadian Network for Autoimmune Liver Disease
CaNAL
1 other identifier
observational
2,500
1 country
15
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2018
Longer than P75 for all trials
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 7, 2018
CompletedFirst Submitted
Initial submission to the registry
May 25, 2018
CompletedFirst Posted
Study publicly available on registry
June 26, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2028
June 7, 2021
June 1, 2021
10.8 years
May 25, 2018
June 4, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Liver transplant-free survival over time
Time-to-event
Up to 6 years or time of death/liver transplant
Secondary Outcomes (6)
Biochemical values over time (e.g. aspartate aminotransferase, alkaline phosphatase, alanine aminotransferase, Bilirubin)
Through study completion, an average of 6 months
Short Form 36 (SF-36)
Through study completion, an average of 6 months
PBC-40
Through study completion, an average of 6 months
5D Pruritus Scale
Through study completion, an average of 6 months
Itch Visual Analog Scale
Through study completion, an average of 6 months
- +1 more secondary outcomes
Study Arms (1)
Observational
There is no intervention being administered. This registry only observes patients through their regular standard of care visits.
Interventions
Eligibility Criteria
Patients with a diagnosis of Primary Biliary Cholangitis and/or Autoimmune Hepatitis across Canada.
You may qualify if:
- Diagnosis of Primary Biliary Cholangitis and/or Autoimmune Hepatitis
You may not qualify if:
- Less than 18 years of age
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Foothills Medical Centre
Calgary, Alberta, T2N 2T9, Canada
University of Alberta Hospital
Edmonton, Alberta, T6G 2B7, Canada
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9, Canada
St. Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6, Canada
Health Sciences Centre
Winnipeg, Manitoba, R3A 1R9, Canada
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, B3H 2Y9, Canada
McMaster University Medical Centre
Hamilton, Ontario, L8S 4K1, Canada
Kingston Health Sciences Centre (HDH Site)
Kingston, Ontario, K7L 5G2, Canada
London Health Sciences Centre - University Hospital
London, Ontario, N6A 5A5, Canada
The Ottawa Hospital
Ottawa, Ontario, K1H 8L6, Canada
Toronto General Hospital
Toronto, Ontario, M5G 2C4, Canada
Centre hospitalier de l'Université de Montréal
Montreal, Quebec, H2X 0A9, Canada
McMaster University Medical Centre
Montreal, Quebec, H4A 3J1, Canada
Université de Sherbrooke
Sherbrooke, Quebec, J1G2E8, Canada
Royal University Hospital
Saskatoon, Saskatchewan, S7N 0W8, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bettina Hansen, PhD
University Health Network, Toronto General Hospital
- PRINCIPAL INVESTIGATOR
Andrew Mason, MD
University of Alberta
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Target Duration
- 6 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 25, 2018
First Posted
June 26, 2018
Study Start
February 7, 2018
Primary Completion (Estimated)
December 1, 2028
Study Completion (Estimated)
December 1, 2028
Last Updated
June 7, 2021
Record last verified: 2021-06
Data Sharing
- IPD Sharing
- Will not share
Patient data will be anonymized. A standardized electronic case record (e-CRF) form will be used to capture the data. The e-CRF form has been designed in REDCap, a secure web based application supporting data capture for research studies. REDCap is designed to comply with HIPAA security regulations. The CaNAL REDCap database (REDCap project CaNAL) has been established at the University of Alberta under the jurisdiction of the Women and Children's Health Research Institute (WCHRI). Individual centres will have access only to their own data and patient identifiers will only be visible to the individual centres. The steering committee will have access to all anonymized data within the REDCap database, that is without any patient identifiers. Main centres in Toronto and Edmonton will have access to de-identified data. Results will be disseminated via publication in international literature and presentation at international liver conferences. Patient data will be anonymous.