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The Multi-Center Study on Quantitative Assessment of Diffuse Liver Disease Using Combined Ultrasonic Multimodal Imaging and Artificial Intelligence Algorithm

The Multi-Center Study on Quantitative Assessment of Diffuse Liver Disease Using Combined Ultrasonic Multimodal Imaging and Artificial Intelligence Algorithm

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500109717
Enrollment
Unknown
Registered
2025-09-24
Start date
2025-10-15
Completion date
Unknown
Last updated
2025-09-29

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

Conditions

Chronic liver disease

Interventions

Autoimmune liver disease group:None
Normal control group:None

Sponsors

Zhongshan Hospital Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1 Normal control group patients: (1).Chinese citizens aged 18 to 85 years old; (2).with a normal BMI range of (18.5-23.9 kg/m^2), and imaging or blood biomarkers/scores, or liver histological tests indicating normal liver function; (3).excluding chronic liver diseases such as metabolic-related fatty liver disease, hyperlipidemia, diabetes, and viral hepatitis; 2. MAFLD group patients: (1).Chinese citizens aged 18 to 85 years old; (2).meeting the diagnostic criteria for metabolic-related fatty liver disease: presence of hepatic steatosis in imaging or blood biomarkers/scores, liver histological tests, and meeting one of the following three criteria: being overweight/obese (BMI >=23 kg/m^2), type 2 diabetes (T2DM), or metabolic disorders. Metabolic disorder is defined as meeting at least two of the following abnormalities: 1) Waist circumference >=90/80cm (male/female); 2) Blood pressure >=130/85mmHg or medication therapy; 3) Plasma triglycerides >=150mg/dl(>=1.70mmol/L) or special drug therapy; 4) Plasma high-density lipoprotein cholesterol: male =2.5; 7) Plasma C-reactive protein level>2 mg/L; 3. Hepatitis B diagnosis group: 1).Chinese citizens aged >=18 years and =18 and <=85 years; (2). According to the diagnosis and treatment guidelines for autoimmune hepatitis.

Exclusion criteria

Exclusion criteria: Exclusion criteria: 1.Age 85 years; 2.Pregnant patients; 3.Patients who have undergone or are undergoing systemic chemotherapy, or those who have undergone TACE surgery; patients with tumors in the liver segment to be sampled; 4.Other types of viral hepatitis, alcohol-related fatty liver disease (past 12-month alcohol intake equivalent to >=30g/d for males, >=20g/d for females), and drug-induced liver injury; 5.Patients refusing to sign informed consent forms; 6.Patients at significant bleeding risk during biopsy (platelet count <50%).

Design outcomes

Primary

MeasureTime frame
areas under ROC;

Countries

China

Contacts

Public ContactXu Huixiong

Zhongshan Hospital Fudan University

xu.huixiong@zs-hospital.sh.cn+86 189 1768 3519

Outcome results

None listed

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