Carcinoma, Hepatocellular, Cirrhosis, Liver, Hepatitis B, Chronic, Hepatitis C, Chronic, Non-Alcoholic Fatty Liver Disease
Conditions
Brief summary
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.
Interventions
BEHAVIORALLiver cancer surveillance every 3 months
Follow up every 3 months for liver cancer surveillance, including but not limited to serum AFP test and ultrasound exam
BEHAVIORALLiver cancer surveillance every 6 months
Follow up every 6 months for liver cancer surveillance, including but not limited to serum AFP test and ultrasound exam
BEHAVIORALLiver cancer surveillance annually
Follow up annually for liver cancer surveillance, including but not limited to serum AFP test and ultrasound exam
Sponsors
Ruijin Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. 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\[17\] 2. Age: 18 to 75 years old (including the cut-offs) 3. Subjects must meet at least one of the following criteria for enrollment. 1. Patients diagnosed with chronic hepatitis B in hospital or out of hospital: persistent positive hepatitis B surface antigen (HBsAg) for 6 months or more 2. Patients diagnosed with hepatitis C in hospital or out of hospital 3. Patients diagnosed with cirrhosis in hospital or out of hospital who meet at least one of the following criteria. 1. Liver biopsy showing cirrhosis (Ishak score ≥5 or Metavir score = 4); 2. 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; 3. Abdominal imaging results showing characteristic of cirrhosis (results showing coarse liver echotexture or nodular, parenchymal, or morphological abnormalities and signs of gastroesophageal varices); 4. APRI ≥ 2.0; 5. FIB-4 ≥ 3.25 4. 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. 5. 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% 6. Subjects with a family history of liver cancer in their first-degree biological relatives.
Exclusion criteria
Patients meeting any of the following criteria will be excluded from the study: 1. Age \<18 years or \>75 years 2. Patients who have been diagnosed with liver cancer before enrollment 3. Patients with severe mental illness or cognitive impairment 4. Patients who are pregnant or lactating, or preparing to become pregnant 5. Patients who have participated in other clinical trials or are participating in other clinical trials within 3 months prior to initiation of study treatment 6. According to the doctor's judgment, the possibility of the subject being included is low (including inability to understand the project requirements , poor compliance, infirmity, inability to ensure that the protocol can be implemented as required, etc.), or the doctor determines that the subject has any other factors that are not suitable for this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Early diagnosis rate of HCC patients | Follow up up to three years for HCC occurance. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The 3-year cumulative incidence of liver cancer in each subject category according to the risk stratification at the time of initial diagnosis | Four years collectively after the study started | The 3-year cumulative incidence of liver cancer for subjects with very high-risk, high-risk, medium-risk, and low-risk, respectively |
| Proportion of subjects with regular follow-up | Four years collectively after the study started | 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 | Initial screening after enrollment | 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 | Last follow-up visit or at the time of diagnosis of liver cancer up to three years of follow-up | 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 | Follow up up to 3 years | — |
| The early diagnosis rate of liver cancer in each subject category according to the risk stratification at initial screening | Initial screening after enrollment | The early diagnosis rate of liver cancer of subjects with very high-risk, high-risk, medium-risk, and low-risk at initial screening, respectively |
Other
| Measure | Time frame | Description |
|---|---|---|
| The number of patients first diagnosed with liver cancer and the annual incidence rate | Four years collectively after the study started | — |
| The number of patients first diagnosed with liver cancer and the annual incidence rate within each risk category | Four years collectively after the study started | — |
| 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 | Four years collectively after the study started | — |
| The 3-year cumulative incidence of liver cancer in each disease subgroup | Follow up up to 3 years | The disease types include but are not limited to hepatitis B, hepatitis C, cirrhosis, MAFLD |
| Early diagnosis rate of HCC in each disease subgroup | Four years collectively after the study started | The disease types include but are not limited to hepatitis B, hepatitis C, cirrhosis, MAFLD; early diagnosis of HCC is defined as the patient with stage CNLC Ia, Ib and IIa |
| The compliance rate of each risk group defined at the initial risk stratification | Four years collectively after the study started | The compliance rates for subjects with very high-risk, high-risk, medium-risk, and low-risk; the compliance rate is defined the same as above |
Countries
China
Contacts
Primary ContactQing Xie, MD
Backup ContactHonglian Gui, MD,PhD
Outcome results
None listed