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Research on the Construction and Application of an Autoantibody-Specific Multi-Target Nano Biosensing System Based on Janus Metal-Organic Frameworks (MOFs)

Research on the Construction and Application of an Autoantibody-Specific Multi-Target Nano Biosensing System Based on Janus Metal-Organic Frameworks (MOFs)

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500107846
Enrollment
Unknown
Registered
2025-08-20
Start date
2025-10-01
Completion date
Unknown
Last updated
2025-08-25

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

Conditions

Autoimmune Hepatitis

Interventions

Healthy control group:None
Case Group:None

Sponsors

Tianjin Third Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Case Group Diagnostic Criteria:Meet international diagnostic criteria for autoimmune liver diseases (American Association for the Study of Liver Diseases [AASLD]/European Association for the Study of the Liver [EASL]), with a simplified score =6 or comprehensive score =10, and liver biopsy confirming interface hepatitis. Age Range: 18–75 years, any gender. Sample Requirements:Treatment-naïve patients or patients undergoing treatment (with detailed medication history recorded). Serum samples must be free of hemolysis or lipemia and stored at -80°C. 2. Healthy Control Group:Age and gender: Matched to the case group. Liver function: Normal (ALT/AST <=1.5 times the upper limit of normal [ULN]). Medical history: No history of liver diseases, autoimmune disorders, or malignancies. Autoantibody screening: Negative (e.g., ANA <1:80, ASMA/AMA negative).

Exclusion criteria

Exclusion criteria: 1. Case Group Exclusions Coexisting liver diseases (e.g., positive HBV-DNA/HCV-RNA, alcohol intake >20g/day, drug-induced liver injury). Use of immunosuppressants (e.g., corticosteroids, azathioprine) or biologic agents within the past 3 months. Comorbidities including HIV infection, malignancies, or severe cardiopulmonary diseases. Pregnancy or lactation. Poor-quality samples (e.g., severe hemolysis, >3 freeze-thaw cycles). 2. Healthy Control Group Exclusions Recent infections or inflammatory diseases (within the past 6 months). Positive autoantibody screening (e.g., ANA =1:80, ASMA/AMA positive).

Design outcomes

Primary

MeasureTime frame
Autoantibodies;Anti–soluble liver antigen/liver–pancreas antigen antibody;Anti-Smooth Muscle Antibody;Anti-Neutrophil Cytoplasmic Ab;Anti-Liver/Kidney Microsomal;Anti-Liver Cytosol 1;

Countries

China

Contacts

Public ContactYu Zhu

Tianjin Third Central Hospital

zhuyutj@126.com+86 138 2001 8157

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026