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临床试验/NCT05335603
NCT05335603招募中不适用

Fatty Liver Library (FALL): a Prospective Cohort Study Evaluating the Characteristics of Chronic Liver Diseases Associated With Hepatic Steatosis

University of Copenhagen1 个研究点 分布在 1 个国家目标入组 335 人开始时间: 2020年8月24日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nicolai Jacob Wewer Albrechtsen

Associate professor

University of Copenhagen

研究点 (1)

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