An observational study in Carcinoma, Hepatocellular, Hepatitis C, Chronic and Hepatitis B, Chronic, sponsored by Ruijin Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-05-23.
Sponsored by Ruijin Hospital · Observational
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.
2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.
This study's planned enrollment of 20,000 is above the median of 250 across 687 observational studies indexed under Hepatitis A.
Browse Hepatitis A studies →Ruijin Hospital is the lead sponsor of 635 studies on the registry; 359 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Subjects must meet at least one of the following criteria for enrollment.
Patients diagnosed with cirrhosis in hospital or out of hospital who meet at least one of the following criteria.
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].
Patients diagnosed with MAFLD combined with abnormal glucose metabolism[19]
Exclusion Criteria:
Patients meeting any of the following criteria will be excluded from the study:
Behavioral: Liver cancer surveillance every 3 months
Behavioral: Liver cancer surveillance every 3 months
Behavioral: Liver cancer surveillance every 6 months
Behavioral: Liver cancer surveillance annually
Follow up every 3 months for liver cancer surveillance, including but not limited to serum AFP test and ultrasound exam
Follow up every 6 months for liver cancer surveillance, including but not limited to serum AFP test and ultrasound exam
Follow 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.
Time frame: Follow up up to three years for HCC occurance.
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.
Time frame: Four years collectively after the study started
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
Time frame: Initial screening after enrollment
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
Time frame: Last follow-up visit or at the time of diagnosis of liver cancer up to three years of follow-up
Pooled 3-year cumulative incidence of liver cancer
Time frame: 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
The early diagnosis rate of liver cancer of subjects with very high-risk, high-risk, medium-risk, and low-risk at initial screening, respectively
Time frame: Initial screening after enrollment
The 3-year cumulative incidence of liver cancer in each subject category according to the risk stratification at the time of initial diagnosis
The 3-year cumulative incidence of liver cancer for subjects with very high-risk, high-risk, medium-risk, and low-risk, respectively
Time frame: Four years collectively after the study started
The number of patients first diagnosed with liver cancer and the annual incidence rate
Time frame: 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
Time frame: 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
Time frame: Four years collectively after the study started
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
Time frame: Follow up up to 3 years
Early diagnosis rate of HCC in each disease subgroup
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
Time frame: Four years collectively after the study started
The compliance rate of each risk group defined at the initial risk stratification
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
Time frame: Four years collectively after the study started
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