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Evaluation of the Efficacy of Hepatic Lipotoxic Combinations for Non-invasive Diagnosis of MASH

Evaluation of the Efficacy of Hepatic Lipotoxic Combinations for Non-invasive Diagnosis of MASH

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600121974
Enrollment
Unknown
Registered
2026-04-07
Start date
2026-05-01
Completion date
Unknown
Last updated
2026-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic associated fatty liver disease

Interventions

Gold Standard:NAFLD Activity Score and Fibrosis Staging of Liver Biopsy Specimens
Index test:lipotoxic metabolites in exosome (lysophospholipids?ceramides)

Sponsors

Beijing Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Population meeting the diagnostic criteria specified in the Guidelines for the Prevention and Treatment of Metabolic Dysfunction-Associated (Non-Alcoholic) Fatty Liver Disease (2024 Edition), with fatty liver disease of other etiologies excluded, and possessing complete clinical baseline data, laboratory examination data and imaging examination data. 2. Population who voluntarily undergo liver biopsy and have qualified pathological specimens; 3. Inclusion Criteria for MAFLD Subgroups : (1) Patients must meet the general inclusion criteria, and be diagnosed with simple fatty liver disease definitively by liver biopsy pathology. The pathological findings show no hepatocellular ballooning, with mild or no lobular inflammation, and a NAS of less than 3; (2) Patients with liver fibrosis staged as Metavir F0 or Metavir F1; 4. Inclusion Criteria for MASH Subgroups : 1.Patients must meet the general inclusion criteria, and be diagnosed with MASH definitively by liver biopsy pathology. Core pathological features must be satisfied: hepatocellular steatosis (>=5%) + hepatocellular ballooning + lobular inflammation. A definitive MASH diagnosis requires a NAS >=5; alternatively, MASH can be diagnosed with a NAS score of 3–4 combined with clinical high-risk factors. (2) Patients with liver fibrosis staged as Metavir F1, F2, or F3.

Exclusion criteria

Exclusion criteria: 1. Individuals with incomplete clinicopathological data; 2. Individuals with viral hepatitis, autoimmune hepatitis, or other known chronic liver diseases; 3. Individuals taking potential hepatotoxic drugs; 4. Individuals with heavy alcohol consumption (>=140 grams/week for males or >=70 grams/week for females). 5. Patients with liver fibrosis staged as Metavir F4.

Design outcomes

Primary

MeasureTime frame
Hepatic Exosomal Lipid Metabolite Components;NASH Activity Score;Fibrosis Staging;sensitivity;specificity;Positive Predictive Value;Negative Predictive Value;

Countries

China

Contacts

Public ContactXiuqing Huang

Beijing Hospital

huangxiuqing3768@bjhmoh.cn+86 10 85138520

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 17, 2026