Diagnostic Accuracy of the "LLIFT", a Novel Non-invasive Biomarker for the Diagnosis of Non Alcoholic Fatty Liver (NAFL) and SteatoHepatitis (NASH) in a Population With High Risk of Metabolic Syndrome"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 158
- 试验地点
- 7
- 主要终点
- The Area under receiver operating characteristic (ROC) curve (AUC) of the LLIFT (Lille LIver Fat Test)-NASH score
研究概览
简要总结
The NAFLD is the first cause of liver disease worldwide. The severe form of NAFLD, the NASH progresses to cirrhosis and is responsible of liver mortality. The diagnosis of NASH requires liver biopsy that cannot be used for the screening of the disease.
The broad prevalence of the disease limits also the generalization of liver biopsy even for diagnosis. There is an urgent need for the use and the validation of liver diagnosis biomarkers for the diagnosis of NASH.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients with 1 at least of the following metabolic criteria :
- •BMI > 30 kg/m²,
- •Type 2 diabetes (glycemia > 1.26 g/L or under therapy)
- •hypertension (> 140 mmHg / 90 mmHg or under therapy) associated with increased hepatic enzymes
- •Indication of NAFLD evaluation
- •Patients written consent
- •Affiliated to a social insurance
排除标准
- •Contraindications for liver biopsy or MRI.
- •Other confounding cause of liver disease (HCV, HBV, HCC, autoimmune liver disease, Hemochromatosis, Wilson disease.
- •alcohol consumption higher than 140g/week for women and 210g/week for men
- •Previous history of alcohol abuse (addiction).
- •Eluding stent < 6 month or acute coronary syndrome within 1 year or non-eluding stent within 6 weeks.
- •Hepatocellular carcinoma
- •Being processed Cancer (chemotherapy, radiotherapy or hormone therapy)
- •Pregnant or breastfeeding women.
- •Drug abuse within the past year.
- •Mentally unbalanced patients, under supervision or guardianship
结局指标
主要结局
The Area under receiver operating characteristic (ROC) curve (AUC) of the LLIFT (Lille LIver Fat Test)-NASH score
时间窗: Baseline
The variables constituting the calculation algorithm are : clinical data (age, gender, BMI, diabetes status), biological data (AST, ALT, GCT, fasting glucose, HbA1c, triglyceride,...) and genetic polymorphism
次要结局
- Assessment of the correlation between the LLIFT score and the NAS score(Baseline)
- The Area under receiver operating characteristic (ROC) curve (AUC) of the LLIFT (Lille LIver Fat Test)- steatosis score(Baseline)