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Набор скоро начнётся NCT04925362

THE FRENCH NATIONAL NAFLD COHORT (FRench pAtients With MEtabolic Steatosis)

Без фазы С лечением NAFLD NASH NASH - Nonalcoholic Steatohepatitis Fibrosis

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: Biological specimens, Additional visit.
Кому может быть актуально
Состояния в реестре: NAFLD, NASH, NASH - Nonalcoholic Steatohepatitis, Fibrosis. 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
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Identification of Clinical and Biological Factors Determining Disease Severity and Disease Progression in NAFLD: "THE FRENCH NATIONAL NAFLD COHORT" FRAMES (FRench pAtients With MEtabolic Steatosis)

Обзор

The main objective of this cohort study is to determine genetic, clinical biologic and metabolic factors associated with patient heterogeneity in regards to severity of NAFLD at diagnosis as well as during the clinical course. * at diagnosis, with the aim to better characterize patients of different severity and improve our understanding of clinical and histological heterogeneity at diagnosis * during the clinical course to better understand and predict disease progression in terms notably of fibrosis progression and progression to cirrhosis

Подробное описание

Non-alcoholic fatty liver disease (NAFLD) is considered the hepatic manifestation of metabolic syndrome and is currently the most common cause of liver disease in many developed countries worldwide.

The aim of the study is to improve the scientific knowledge on markers associated with disease severity and progression in NAFLD.

The study is a multicentre French NAFLD cohort of well-characterized patients with biological samples covering the entire spectrum of NAFLD severity (steatosis, NASH, significant fibrosis, cirrhosis, hepatocellular carcinoma).

Вмешательства

  • Другое Biological specimens
    Biological specimens are collected to better characterize patients of different severity and improve our understanding of clinical and histological heterogeneity at diagnosis : * added for the research : blood, urine, stools * collected for the research : liver tissue sample, if a liver biopsy is indicated for clinical reasons (standard of care)
  • Другое Additional visit
    Visits if possible during standard care, otherwise added by the research (If necessary the annual visit will be added by research for the collection of biological samples)

Первичные конечные точки

  • Disease severity [Срок оценки: Change of the fibrosis stage from baseline to 10 years]
Вторичные конечные точки (12)
  • Ballooning grade [Срок оценки: At baseline]
  • Lobular inflammation [Срок оценки: At baseline]
  • Steatohepatitis [Срок оценки: At baseline]
  • Cirrhosis [Срок оценки: Through study completion, an average of 10 years]
  • Obesity [Срок оценки: Change from baseline to 10 years]
  • Type 2 diabetes [Срок оценки: Change from baseline to 10 years]
  • Dyslipidaemia [Срок оценки: Change from baseline to 10 years]
  • Cardiovascular disease [Срок оценки: Change from baseline to 10 years]
  • Necroinflammation measured by the activities component of the SAF [Срок оценки: Change from baseline to 10 years]
  • Necroinflammation measured by the NAS score [Срок оценки: Change from baseline to 10 years]
  • Fasting insulin [Срок оценки: Change from baseline to 10 years]
  • Insulin sensitivity [Срок оценки: Change from baseline to 10 years]

Критерии участия

Критерии включения

  • Age ≥18 years
  • Patients with a confirmed diagnosis of NAFLD
  • Patients affiliated to French social security
  • Written informed consent signed by the patient

Критерии исключения

  • Refusal or inability (lack of capacity) to give informed consent.
  • Average alcohol ingestion greater than 21/14 units/week (males/females) in the preceding 6 months or history of sustained excessive consumption of alcohol in past 5 years.
  • History or presence of Type 1 diabetes mellitus.
  • Presence of any other form of chronic liver disease except NAFLD
  • Recent (within 12 months) or concomitant use of agents known to cause hepatic steatosis (long-term systemic corticosteroids \[>10 days\], amiodarone, methotrexate, tamoxifen, tetracycline, high dose oestrogens, valproic acid).
  • Any contra-indication to liver biopsy.
  • Recent (within 3 months) change in dose/regimen or introduction of Vitamin E (at a dose ≥400 IU/day), betaine, s-adenosyl methionine, ursodeoxycholic acid, silymarin or pentoxifylline.
  • Non-French speaking/unable to access an interpreter.
  • Patients judged by the investigator to be unsuitable for inclusion in the study (e.g. judged by the physician as unlikely to be compliant with the study protocol).
  • Pregnant or breastfeeding women
  • Patient under legal protection measure (tutorship or curatorship) and patient deprived of freedom

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Диагностика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT04925362 · APHP190417 · 2019-A01308-49

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗