JPRN-UMIN000018158已完成未知
Diagnostic accuracy of novel scoring systems using serum biomarkers for nonalcoholic steatohepatitis (NASH) - Diagnosis of nonalcoholic steatohepatitis by serum biomarkers
Saiseikai Suita Hospital0 个研究点目标入组 400 人开始时间: 2015年7月2日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 400
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 20years-old 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1) Patients whose alcohol consumption in the preceding year of the liver biopsy were more than 210g/week (30g/day) for men or 140g/week (20g/day) for women (at the time of liver biopsy and blood sampling) 2) Patients who have the following result(s) of immunological test (at the time of liver biopsy and blood sampling) -Hepatitis B (HBs antigen >=0.05U/ml) -Hepatitis C (HCV RNA positive) -Patients who are autoimmune hepatitis (titer of antinuclear antibodies is equal to or more than 80 fold and IgG is equal to or more than 2g/dL, or autoimmune hepatitis diagnosed by histopathology) -Patients who are primary biliary cirrhosis 3) Patients who are suspected another chronic liver disease (at the time of liver biopsy and blood sampling) (e.g., primary sclerosing cholangitis, hemochromatosis, alpha1-antitrypsin deficiency, Wilson's disease, drug-induced hepatic impairment (including fatty liver induced by adrenocortical steroid)) 4) Patients who have history of hepatic, biliary or pancreatic malignant tumor 5) Patients who have liver decompensation such as hepatic encephalopathy, abdominal dropsy,jaundice, variceal hemorrhage, serum bilirubin level more than 2 times of the upper limit of normal (at the time of liver biopsy and blood sampling) 6) Patients whose preserved serum sample repeated freeze-thaw cycles more than six times 7) Patients whose preserved serum sample(s) and/or liver specimen are unsuitable for the diagnosis of NASH in the opinion of the investigator. 8) In the opinion of the investigator, patient are unsuitable as a study subject
研究者
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