Nonalcoholic fatty liver disease (NAFLD)
Conditions
Interventions
None listed
Sponsors
Saiseikai Suita Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients who have received a diagnosis of NAFLD (at the time of liver biopsy and blood sampling) 2) Patients who got liver biopsy for the diagnosis of NASH from April 2013 to April 2015 and whose liver biopsy sample has been stored 3) Patients whose serum sample was collected within 3 month before or after the liver biopsy and have been stored at or under -80 degrees Celsius 4) Patients whose liver biopsy sample is equal to or longer than 1.5 cm (if the needle size was 16 gauge or bigger) or is equal to or longer than 2.0 cm (if the needle size was 17 or 18 gauge) 5) Patients who are 20 or over 20 years old on the day of signing informed consent. In the case that the informed consent was not required according to the applicable ethical guidelines (Part 12 1 (2) A (b) of "Ethical Guidelines for Medical and Health Research Involving Human Subjects"), the patient must be 20 or over 20 years old when the information of the study is made public. 6) Patients who voluntarily agree to participate in the study by providing written informed consent. However, this may not be applicable if the requirements mentioned in Part 12 1 (2) A (b) of "Ethical Guidelines for Medical and Health Research Involving Human Subjects" are satisfied.
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area Under the Receiver Operating Characteristic (AUROC) of the scoring systems against the standard method (histopathological diagnosis) in the diagnosis of fibrotic NASH. | — |
Secondary
| Measure | Time frame |
|---|---|
| Area Under the Receiver Operating Characteristic (AUROC) of ELF panel score against the standard method (histopathological diagnosis) in the diagnosis of fibrotic NASH. | — |
Countries
Japan
Contacts
Public ContactFumiyuki Iida
Sogo Rinsho Medefi Co.,Ltd. Business promotion department
Outcome results
None listed