Canadian Network for Autoimmune Liver Disease (CaNAL)

June 4, 2021 updated by: University Health Network, Toronto

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

2500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 2T9
        • Not yet recruiting
        • Foothills Medical Centre
        • Contact:
      • Edmonton, Alberta, Canada, T6G 2B7
        • Recruiting
        • University of Alberta Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Andrew Mason, MD
        • Sub-Investigator:
          • Aldo Montano-Loza, MD
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Not yet recruiting
        • Vancouver General Hospital
        • Contact:
        • Principal Investigator:
          • Eric M Yoshida, MD
      • Vancouver, British Columbia, Canada, V6Z 1Y6
        • Not yet recruiting
        • St. Paul's Hospital
        • Contact:
          • Hin Hin Ko, MD
          • Phone Number: 604-688-6332
        • Principal Investigator:
          • Hin Hin Ko, MD
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A 1R9
        • Not yet recruiting
        • Health Sciences Centre
        • Contact:
        • Principal Investigator:
          • Nabiha Faisal, MD
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • Active, not recruiting
        • Queen Elizabeth II Health Sciences Centre
    • Ontario
      • Hamilton, Ontario, Canada, L8S 4K1
        • Not yet recruiting
        • McMaster University Medical Centre
        • Contact:
          • Marco Puglia, MD
        • Principal Investigator:
          • Marco Puglia, MD
      • Kingston, Ontario, Canada, K7L 5G2
        • Active, not recruiting
        • Kingston Health Sciences Centre (HDH Site)
      • London, Ontario, Canada, N6A 5A5
        • Recruiting
        • London Health Sciences Centre - University Hospital
        • Contact:
        • Principal Investigator:
          • Karim Qumosani, MD
      • Ottawa, Ontario, Canada, K1H 8L6
        • Recruiting
        • The Ottawa Hospital
        • Principal Investigator:
          • Angela Cheung, MD
        • Contact:
        • Contact:
      • Toronto, Ontario, Canada, M5G 2C4
    • Quebec
      • Montreal, Quebec, Canada, H4A 3J1
        • Not yet recruiting
        • McMaster University Medical Centre
        • Contact:
          • Marc Deschenes
        • Contact:
        • Principal Investigator:
          • Marc Deschenes, MD
      • Montréal, Quebec, Canada, H2X 0A9
        • Recruiting
        • Centre Hospitalier de l'Universite de Montreal
        • Contact:
        • Principal Investigator:
          • Catherine Vincent, MD
      • Sherbrooke, Quebec, Canada, J1G2E8
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N 0W8
        • Recruiting
        • Royal University Hospital
        • Contact:
        • Principal Investigator:
          • Lawrence Worobetz, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with a diagnosis of Primary Biliary Cholangitis and/or Autoimmune Hepatitis across Canada.

Description

Inclusion Criteria:

  • Diagnosis of Primary Biliary Cholangitis and/or Autoimmune Hepatitis

Exclusion Criteria:

  • Less than 18 years of age

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Liver transplant-free survival over time
Time Frame: Up to 6 years or time of death/liver transplant
Time-to-event
Up to 6 years or time of death/liver transplant

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biochemical values over time (e.g. aspartate aminotransferase, alkaline phosphatase, alanine aminotransferase, Bilirubin)
Time Frame: Through study completion, an average of 6 months
Investigate trends of different biochemical values over time
Through study completion, an average of 6 months
Short Form 36 (SF-36)
Time Frame: Through study completion, an average of 6 months
Health-Related Quality of Life
Through study completion, an average of 6 months
PBC-40
Time Frame: Through study completion, an average of 6 months
Health-Related Quality of Life, specific to Primary Biliary Cholangitis
Through study completion, an average of 6 months
5D Pruritus Scale
Time Frame: 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
Through study completion, an average of 6 months
Itch Visual Analog Scale
Time Frame: Through study completion, an average of 6 months
Itch-Related Quality of Life; Continuous unitless itch scale from no itch to worst itch imaginable
Through study completion, an average of 6 months
Itch Numeric Rating Scale
Time Frame: 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)
Through study completion, an average of 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Investigators

  • Principal Investigator: Andrew Mason, MD, University of Alberta
  • Principal Investigator: Bettina Hansen, PhD, University Health Network, Toronto General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 7, 2018

Primary Completion (Anticipated)

December 1, 2028

Study Completion (Anticipated)

December 1, 2028

Study Registration Dates

First Submitted

May 25, 2018

First Submitted That Met QC Criteria

June 14, 2018

First Posted (Actual)

June 26, 2018

Study Record Updates

Last Update Posted (Actual)

June 7, 2021

Last Update Submitted That Met QC Criteria

June 4, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAPCR ID: 18-5951

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Autoimmune Hepatitis

Clinical Trials on Observational; no intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Equatorial Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe