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Multidimensional Differential Diagnosis Study of Autoimmune Hepatitis versus Drug-Induced Liver Injury Using Serological, Radiomic, Pathological and Glycomic Approaches

Multidimensional Differential Diagnosis Study of Autoimmune Hepatitis versus Drug-Induced Liver Injury Using Serological, Radiomic, Pathological and Glycomic Approaches

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600128869
Enrollment
Unknown
Registered
2026-07-27
Start date
2026-08-01
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Autoimmune hepatitis

Interventions

AIH group:None
DILI group:None

Sponsors

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Clinical diagnostic criteria: For AIH, diagnosis conforms to the Guidelines for the Diagnosis and Management of Autoimmune Hepatitis (2021 Edition) and is pathologically confirmed by liver biopsy. For DILI, diagnosis follows the Guidelines for the Diagnosis and Treatment of Drug-Induced Liver Injury (2023 Edition) with a RUCAM score >=6, and alternative liver diseases are excluded via liver biopsy; 2.No prior immunosuppressant administration before liver biopsy; if brief immunosuppressive therapy was given, the treatment duration is less than 1 week to avoid interference with pathological findings and all dimensional laboratory measurements. 3.Complete datasets are available, including clinical documentation, serological test results, hepatic MRI images, liver biopsy specimens, and serum samples collected concurrently with biopsy for subsequent glycomic analysis. 4. Age >=18 years and <=80 years, any gender.

Exclusion criteria

Exclusion criteria: 1.Coexistence of other liver diseases, including viral hepatitis, non-alcoholic fatty liver disease, alcoholic liver disease, hepatocellular carcinoma, etc. 2.Concurrent other autoimmune disorders (e.g., systemic lupus erythematosus, rheumatoid arthritis, primary biliary cholangitis) that may interfere with the detection of autoantibodies and immune parameters. 3.Inadequate liver biopsy specimens (fewer than 10 portal tracts) or unqualified pathological sections unavailable for pathological evaluation. 4.Hepatic MRI images with severe artifacts or incomplete scanning parameters, precluding subsequent radiomic analysis. 5.Insufficient or improperly preserved serum samples that cannot fulfill serological and glycomic testing. 6.Accompanied by severe dysfunction of vital organs (heart, kidney, lung, brain), malignant tumors or coagulation disorders which may confound study outcomes.

Design outcomes

Primary

MeasureTime frame
Diagnostic performance;Lab blood test markers;

Countries

China

Contacts

Public ContactGui Honglian

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

lillian_ghl@163.com+86 21 64370045

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 10, 2026