Diagnostic accuracy of novel scoring systems using serum biomarkers for nonalcoholic steatohepatitis (NASH)

Not Applicable

• Conditions: onalcoholic fatty liver disease (NAFLD)

• Registration Number: JPRN-UMIN000018158
• Lead Sponsor: Saiseikai Suita Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-07-02
• Study Completion: 2016-11-10
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

Not provided

Exclusion Criteria

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Area Under the Receiver Operating Characteristic (AUROC) of the scoring systems against the standard method (histopathological diagnosis) in the diagnosis of fibrotic NASH.

Secondary Outcome Measures

Name	Time	Method
Area Under the Receiver Operating Characteristic (AUROC) of ELF panel score against the standard method (histopathological diagnosis) in the diagnosis of fibrotic NASH.