Canadian Network for Autoimmune Liver Disease

Status: Recruiting
Location: See all (15) locations...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Diagnosis of Primary Biliary Cholangitis and/or Autoimmune Hepatitis

Locations
Other Locations
Canada
Foothills Medical Centre
NOT_YET_RECRUITING
Calgary
University of Alberta Hospital
RECRUITING
Edmonton
Queen Elizabeth II Health Sciences Centre
ACTIVE_NOT_RECRUITING
Halifax
McMaster University Medical Centre
NOT_YET_RECRUITING
Hamilton
Kingston Health Sciences Centre (HDH Site)
ACTIVE_NOT_RECRUITING
Kingston
London Health Sciences Centre - University Hospital
RECRUITING
London
Centre hospitalier de l'Université de Montréal
RECRUITING
Montreal
McMaster University Medical Centre
NOT_YET_RECRUITING
Montreal
The Ottawa Hospital
RECRUITING
Ottawa
Royal University Hospital
RECRUITING
Saskatoon
Université de Sherbrooke
RECRUITING
Sherbrooke
Toronto General Hospital
RECRUITING
Toronto
St. Paul's Hospital
NOT_YET_RECRUITING
Vancouver
Vancouver General Hospital
NOT_YET_RECRUITING
Vancouver
Health Sciences Centre
NOT_YET_RECRUITING
Winnipeg
Contact Information
Primary
Surain Roberts, AB
surain.roberts@uhn.ca
613 291 5039
Backup
Kattleya Tirona, BA, CCRP
kattleya.tirona@uhn.ca
416 340 4800
Time Frame
Start Date: 2018-02-07
Estimated Completion Date: 2028-12
Participants
Target number of participants: 2500
Treatments
Observational
There is no intervention being administered. This registry only observes patients through their regular standard of care visits.
Authors
Related Therapeutic Areas
Sponsors
Leads: University Health Network, Toronto

This content was sourced from clinicaltrials.gov