Non-alcoholic Steatohepatitis Registry Platform Study

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 2500

Inclusion Criteria

Inclusion Criteria: (1) Subjects must be between 18 and 75 years old when signing the informed consent form, and must have the ability to sign the consent form independently; (2) NASH patients who meet one of the following conditions: 1. Liver biopsy was performed within 24 months before enrollment, and the pathological diagnosis was NASH and the fibrosis stage was F2 or above; 2. FibroScan-AST (FAST) score = 0.30 within 24 months before enrollment; 3. There are any of the following evidences of fatty liver 1. Controlled attenuation parameter (CAP) > 285 dB/m within 24 months before enrollment; 2. Liver ultrasonography showed fatty liver within 24 months before enrollment; 3. Magnetic resonance imaging-derived proton density fat fraction (MRI-PDFF) examination within 24 months before enrollment showed liver fat fraction = 5%; and any of the following evidence of liver fibrosis 1. Liver stiffness measurement (LSM) = 7.5kPa by vibration-controlled transient elastography (VCTE) within 24 months before enrollment; 2. The elasticity value of magnetic resonance elastography (MRE) examination within 24 months before enrollment is =2.93kPa; 3. If there is no liver biopsy and no liver elastography equipment is available in the research center, FIB-4>1.3 (under 65 years old) or>2 (over 65 years old) within 3 months before enrollment. Exclusion Criteria: 1. History of liver transplantation; 2. Patients with bleeding tendency or coagulation dysfunction (for example, bleeding tendency, such as hemophilia, suspected hemangioma or suspected hydatid infection); 3. Exclude liver diseases caused by the following causes: alcoholic steatohepatitis, drug-induced, viral or autoimmune hepatitis, primary hemochromatosis, a1-antitrypsin deficiency, hepatolenticular degeneration, hypothyroidism, inflammatory bowel disease, Cushing's syndrome, celiac disease, ß lipoprotein deficiency, lipoatrophic diabetes mellitus, Mauriac syndrome, hypopituitarism, hypogonadism, polycystic ovarian syndrome; 4. Have a history of malignant tumors in the past 5 years, excluding malignant tumors that have been cured by the investigator's judgment; 5. Pregnant or lactating women.

Exclusion Criteria

Not provided

Study & Design

Study Type: Observational [Patient Registry]

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Patient demography;2.The proportion of 4 NASH treatment modalities at baseline and follow-up;3.NASH Knowledge, Belief and Practice Questionnaire responses at baseline and follow-up

Secondary Outcome Measures

Name	Time	Method
1. The correlation between non-invasive diagnostic methods and pathological results of liver biopsy in NASH patients;2.The annual frequency of liver related visits;3.Total liver-related cost