The goal of this study is to evaluate whether the standardized liver cancer risk stratification management can effectively improve the early diagnosis rate of liver cancer in the targeted risk population in China.
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
Age <18 years or >75 years
Patients who have been diagnosed with liver cancer before enrollment
Patients with severe mental illness or cognitive impairment
Patients who are pregnant or lactating, or preparing to become pregnant
This study mainly includes the following risk groups of liver cancer: patients with chronic hepatitis B, patients with hepatitis C, patients with liver cirrhosis, patients with metabolic dysfunction-associated fatty liver disease (MAFLD) with a liver fibrosis index F3 or above, MAFLD patients combined with abnormal glucose metabolism, and people with a family history of liver cancer in their first-degree biological relatives.
Cohort
Prospective
Liver cancer surveillance every 3 months
BehavioralFollow up every 3 months for liver cancer surveillance, including but not limited to serum AFP test and ultrasound exam
Liver cancer surveillance every 6 months
BehavioralFollow up every 6 months for liver cancer surveillance, including but not limited to serum AFP test and ultrasound exam
Liver cancer surveillance annually
BehavioralFollow up annually for liver cancer surveillance, including but not limited to serum AFP test and ultrasound exam
Early diagnosis rate of HCC patients
The proportion of patients who are first diagnosed with HCC at early stage to all the patients diagnosed as liver cancer in the study, from the start of the study to the completion of follow-up. Early diagnosis is defined as the patient with stage CNLC Ia, Ib and IIa.
Proportion of subjects with regular follow-up
Regular follow-up is defined as the average difference between the actual treatment time and the theoretical treatment time equal or less than 1/3 * Actual visit interval: actual visit date - previous visit date ② Theoretical visit interval: theoretical visit date (the date that physician advise to return to hospital for visit) - previous visit date ③ Follow-up compliance = (②-①)/② ④ Patient with regular follow-up is defined as the patient whose mean follow-up compliance is equal to, or less than 1/3 * The compliance of the study is defined as the proportion of subjects with regular follow-up to all subjects in the study.
The distribution of risk stratification of liver cancer in subjects at initial screening
The proportion of very high-risk, high-risk, medium-risk, and low-risk subjects to the whole subject population
The distribution of risk stratification of liver cancer in subjects at the last follow-up visit or at the time of diagnosis of liver cancer
The proportion of very high-risk, high-risk, medium-risk and low-risk subjects to the whole subject population
Pooled 3-year cumulative incidence of liver cancer
The number of patients first diagnosed with liver cancer and the annual incidence rate
The number of patients first diagnosed with liver cancer and the annual incidence rate within each risk category
The distribution of the CNLC staging of patients diagnosed as liver cancer first from the start of the study to the completion of follow-up
The 3-year cumulative incidence of liver cancer in each disease subgroup
The disease types include but are not limited to hepatitis B, hepatitis C, cirrhosis, MAFLD
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