Fatty Liver Library (FALL): a Prospective Cohort Study Evaluating the Characteristics of Chronic Liver Diseases Associated With Hepatic Steatosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 335
- 试验地点
- 1
- 主要终点
- Identification and validation of a diagnostic classifier enabling discrimination of chronic liver diseases.
研究概览
简要总结
Hepatic steatosis may cause inflammation and fibrosis within the liver potentially leading to end-stage liver disease cirrhosis, liver failure and death. The condition is associated with several other chronic liver diseases like autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis, hereditary hemochromatosis and alpha-1-antitrypsin deficiency and may also develop secondary to other diseases like inflammatory bowel disease and chronic pancreatitis. Diagnosing chronic liver diseases can be challenging and treatment may be limited. In-depth phenotyping at a tissue level may generate insight into the underlying pathophysiology of diseases and furthermore identify common as well as specific diagnostic biomarkers and future treatment targets of the diseases. We therefore undertake a study that evaluates patients with chronic liver diseases associated with hepatic steatosis.
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
- 是
入选标准
- •Adult patients/healthy control participants (age 18 or above) who can give their informed consent
- •Suspected liver disease:
- •non-alcoholic steatohepatitis
- •alcoholic steatohepatitis
- •autoimmune hepatitis
- •primary biliary cholangitis
- •primary sclerosing cholangitis
- •inflammatory bowel disease
- •polycystic ovary syndrome
- •hereditary haemochromatosis
- •chronic pancreatitis
- •cystic fibrosis
- •alpha-1 antitrypsin deficiency
排除标准
- •Patients with:
- •malignant diseases
- •viral hepatitis
- •human immunodeficiency virus
- •contraindications to liver biopsy
结局指标
主要结局
Identification and validation of a diagnostic classifier enabling discrimination of chronic liver diseases.
时间窗: 10 years
OMICS based analyses on plasma and liver tissue
次要结局
- To identify any metabolic disturbances within chronic liver diseases(Plasma obtained at time point 0 min, 15 min, 30 min, 45 min, 60 min, 90 min, 120 min.)
研究者
Nicolai Jacob Wewer Albrechtsen
Associate professor
University of Copenhagen
