Меню
Идёт набор NCT03569826

Canadian Network for Autoimmune Liver Disease

— Наблюдательное Primary Bilary Cirrhosis (PBC) Autoimmune Hepatitis Overlap Syndrome

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Observational; no intervention.
Кому может быть актуально
Состояния в реестре: Primary Bilary Cirrhosis (PBC), Autoimmune Hepatitis, Overlap Syndrome. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Канада
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Обзор

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.

Вмешательства

  • Другое Observational; no intervention
    Observational; no intervention

Первичные конечные точки

  • Liver transplant-free survival over time [Срок оценки: Up to 6 years or time of death/liver transplant]
Вторичные конечные точки (6)
  • Biochemical values over time (e.g. aspartate aminotransferase, alkaline phosphatase, alanine aminotransferase, Bilirubin) [Срок оценки: Through study completion, an average of 6 months]
  • Short Form 36 (SF-36) [Срок оценки: Through study completion, an average of 6 months]
  • PBC-40 [Срок оценки: Through study completion, an average of 6 months]
  • 5D Pruritus Scale [Срок оценки: Through study completion, an average of 6 months]
  • Itch Visual Analog Scale [Срок оценки: Through study completion, an average of 6 months]
  • Itch Numeric Rating Scale [Срок оценки: Through study completion, an average of 6 months]

Критерии участия

Критерии включения

  • Diagnosis of Primary Biliary Cholangitis and/or Autoimmune Hepatitis

Критерии исключения

  • Less than 18 years of age

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Канада · 15 центров
  • Foothills Medical Centre — Calgary
  • University of Alberta Hospital — Edmonton
  • Vancouver General Hospital — Vancouver
  • St. Paul's Hospital — Vancouver
  • Health Sciences Centre — Winnipeg
  • Queen Elizabeth II Health Sciences Centre — Halifax
  • McMaster University Medical Centre — Hamilton
  • Kingston Health Sciences Centre (HDH Site) — Kingston
  • … и ещё 7 центров

Идентификаторы

NCT: NCT03569826 · CAPCR ID: 18-5951

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗