Evaluating the effectiveness of standardized HCC risk stratification management in improving early diagnosis rates in patients with chronic liver disease
This study is a single-center, open-label, single-arm, observational cohort study. Patients with liver disease who visit the Department of Hepatology or related departments (such as Liver Oncology, Hepatitis and Cirrhosis, Complicated and Severe Liver Diseases, Hepatobiliary Surgery, Infectious Diseases, and Geriatrics) will be directly recommended for enrollment by their attending physicians based on the inclusion and exclusion criteria. The study mainly consists of four components: HCC screening, HCC diagnosis, HCC risk stratification, and HCC surveillance follow-up. After enrollment, patients will undergo an initial HCC screening. Those with abnormal screening results will proceed to the HCC diagnostic process and undergo staging according to the China Liver Cancer Staging (CNLC) system. Patients with normal screening results or confirmed non-HCC will be classified into four groups based on their risk of developing HCC (very high risk, high risk, moderate risk, and low risk), and will be assigned corresponding follow-up surveillance protocols, with periodic HCC screening and risk stratification. A high-risk cohort will be established for long-term follow-up observation over three years, with sample retention performed when necessary.
Study Type
OBSERVATIONAL
Enrollment
15,000
The Third People's Hospital of Shenzhen
Shenzhen, Guangdong, China
RECRUITINGEarly diagnosis rate of hepatocellular carcinoma (HCC)
The proportion of participants diagnosed with HCC at an early stage from project initiation until completion of follow-up, defined as the percentage of patients with CNLC stages Ia, Ib, and IIa among all participants with HCC detected in this study.
Time frame: Through study completion, an average of 3 years
Proportion of participants with regular follow-up
Regular follow-up is defined as the mean follow-up adherence being less than 1/3. Definitions: ① Actual visit interval: time of current visit minus time of previous visit. ② Scheduled visit interval: scheduled return visit time (as prescribed at the previous visit) minus time of the previous visit. ③ Follow-up adherence = (1-①/②)/2. The proportion of participants with regular follow-up is defined as the number of participants who meet the criteria for regular follow-up divided by the total.
Time frame: Through study completion, an average of 3 years
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