Digitalized Surveillance Management for Liver Cancer Risk Population in Improving Eearly Diagnosis Efficancy in Chinese Population (dSEARCH)

Inclusion Criteria16

• Voluntary participation in the clinical study; fully informed about the study and signed informed consent, willing to follow and capable of completing all trial procedures\[17\]
• Age: 18 to 75 years old (including the cut-offs)
• Subjects must meet at least one of the following criteria for enrollment.
• Patients diagnosed with chronic hepatitis B in hospital or out of hospital: persistent positive hepatitis B surface antigen (HBsAg) for 6 months or more
• Patients diagnosed with hepatitis C in hospital or out of hospital
• Patients diagnosed with cirrhosis in hospital or out of hospital who meet at least one of the following criteria.
• Liver biopsy showing cirrhosis (Ishak score ≥5 or Metavir score = 4);
• Liver stiffness measurement (LSM) using FibroScan® (Echosens™, Paris, France) ≥12.0 kPa when TB was normal and ALT ≤ 40 IU/mL, or LSM ≥ 17.0 kPa when TB was normal and ALT \< 200 IU/mL;
• Abdominal imaging results showing characteristic of cirrhosis (results showing coarse liver echotexture or nodular, parenchymal, or morphological abnormalities and signs of gastroesophageal varices);
• APRI ≥ 2.0;
• FIB-4 ≥ 3.25
• Patients diagnosed with metabolic dysfunction-associated fatty liver disease (MAFLD) in hospital or out of hospital who have a liver fibrosis score of F3 or higher according to transient elastography, i.e., FibroScan® Liver Stiffness Measurement (LSM) ≥ 10 kPa or the corresponding FibroTouch® measurement threshold\[18\].
• MAFLD diagnosis requires diagnosis of \>5% fat accumulation in liver through either FibroScan® CAP measurements, or similar parameter, or liver biopsy, and in combination with one of the following three conditions: overweight/obesity (BMI \>23 kg/m2), type 2 diabetes, or metabolic dysfunction.
• Patients diagnosed with MAFLD combined with abnormal glucose metabolism\[19\]
• Abnormal glucose metabolism is defined as type 2 diabetes, or prediabetes, i.e. fasting blood glucose 5.6-6.9 mmol/L, or 2h postprandial blood glucose 7.8-11.0 mmol/L, or glycated hemoglobin 5.7%-6.4%
• Subjects with a family history of liver cancer in their first-degree biological relatives.