French Cohort for the Study of Non-invasive Tests of Liver Lesions in NAFLD/NASH (FreSH Cohort)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,005
- 试验地点
- 32
- 主要终点
- Advanced fibrosis in NAFLD
研究概览
简要总结
Currently, the management of non-alcoholic fatty liver disease (NAFLD) patients has two main limitations. First, there is no approved treatment in NAFLD. Second, liver biopsy remains the reference procedure for the evaluation of liver lesions but it is invasive and can't be proposed to all NAFLD patients who represent 25% of the general population. Phase III trials have recently started in NAFLD with the hope of new treatments available in few years on the market. Consequently, we now need to develop and validate the non-invasive tools that will allow the identification of the subset of NAFLD patients who will benefit from treatment with the new drugs once they will be available in clinical practice.
We aim to generate of large multicenter cohort of biopsy-proven NAFLD patients including non-invasive tests of liver lesions (blood tests, elastography devices) and a biobank to promote a research network in the field of non-invasive diagnosis of liver lesions in NAFLD. Eight French centers highly experienced in this field of research will participate to the cohort.
Our primary aim will be to evaluate and improve the non-invasive diagnosis of liver fibrosis in NAFLD. The primary endpoint will be advanced fibrosis as defined by fibrosis stages F3/4 by the NASH-CRN histological semi-quantitative scoring
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
- •NAFLD diagnosis defined by the presence of at least two of the following elements:
- •Liver steatosis (hyperechoic liver on hepatic ultrasound, quantification > 5.6 % by spectroscopy or MRI)
- •Presence of one metabolic risk factor:
- •BMI ≥ 25 kg/m2 or waist circumference ≥ 94 cm (male) / ≥ 80 cm (female)
- •Antihypertensive treatment or systolic BP ≥ 130 mmHg or diastolic BP ≥ 85 mmHg
- •Antidiabetic treatment or fasting blood glucose ≥ 5.6 mmol/l
- •Lipid-lowering treatment or triglycerides ≥ 1.71 mmol/l or HDL cholesterol <1.1 mmol/l (male) / <1.3 mmol/l (female)
- •Dysmetabolic hyperferritinemia
- •Anomaly in the liver enzyme test or liver function tests
- •Indication for liver biopsy in the clinical management of the patient
- •Obtaining the signature of the consent to participate in the study
排除标准
- •Steatogenic treatment (corticosteroids, tamoxifen, amiodarone, methotrexate)
- •Excessive alcohol consumption in the last 5 years (> 210 g / week for men or > 140 g / week for women)
- •Chronic infection with hepatitis B or C
- •Any evidence of other concomitant chronic liver disease
- •Decompensated cirrhosis (ascites, digestive bleeding due to varicose vein rupture, liver failure, hepatocellular failure, hepato-renal syndrome)
- •Hepatocellular carcinoma
- •Pregnant, breastfeeding or parturient women
- •Persons deprived of their liberty by judicial or administrative decision
- •Persons subject to legal protection measures
- •Persons unable to consent
- •Refusal to participate
研究组 & 干预措施
Single arm
Only one arm because diagnostic study evaluating non-invasive tests using liver biopsy as reference
干预措施: biopsy-proven NAFLD patients with non-invasive tests of liver fibrosis (blood tests, elastography devices) and biobank (Diagnostic Test)
结局指标
主要结局
Advanced fibrosis in NAFLD
时间窗: 1 day
Advanced fibrosis defined by a stage of fibrosis F≥ 3 on liver biopsy according to the semi-quantitative histological classification of NASH CRN
次要结局
- Non alcoholic steatohepatitis(1 day)
- Non alcoholic steatohepatitis(1 day)
- Validate the diagnostic performance and thresholds of 2nd generation blood tests compared to 1st generation blood tests(1 day)
- Assessing the prognostic value of non-invasive fibrosis tests for predicting death from liver-related causes(1 day)
- Validate the reliability criteria for Fibroscan in NAFLD, in particular for the XL probe(1 day)
- Validating the performance of the eLIFT algorithm for screening advanced liver fibrosis in NAFLD(1 day)
- Validate the diagnostic performance and thresholds of new elastography devices for the assessment of hepatic fibrosis and steatosis(1 day)
- Defining reliability criteria for Acoustic Radiation Force Impulse and Supersonic Shearwave Imaging in NAFLD(1 day)
- Identify new biomarkers for the non-invasive diagnosis of NASH thanks to collaborations developed by the investigating centres with teams with expertise in 'omics' technologies(1 day)
- Estimate the correlation between a new serum marker, phosphatydylethanol, and alcohol consumption in patients with non-alcoholic fatty liver disease(1 day)