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)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 900
- 主要终点
- Disease severity
研究概览
简要总结
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
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Patients with a confirmed diagnosis of NAFLD
- •Patients affiliated to French social security
- •Written informed consent signed by the patient
排除标准
- •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
结局指标
主要结局
Disease severity
时间窗: Change of the fibrosis stage from baseline to 10 years
The disease severity defined by the fibrosis stage on liver biopsy according to the semi-quantitative histological classification of NASH CRN.
次要结局
- Ballooning grade(At baseline)
- Lobular inflammation(At baseline)
- Type 2 diabetes(Change from baseline to 10 years)
- Fasting insulin(Change from baseline to 10 years)
- Insulin sensitivity(Change from baseline to 10 years)
- Steatohepatitis(At baseline)
- Obesity(Change from baseline to 10 years)
- Cardiovascular disease(Change from baseline to 10 years)
- Necroinflammation measured by the activities component of the SAF(Change from baseline to 10 years)
- Dyslipidaemia(Change from baseline to 10 years)
- Cirrhosis(Through study completion, an average of 10 years)
- Necroinflammation measured by the NAS score(Change from baseline to 10 years)