A Single-center, Open-label, Single-arm, Observational Cohort Study on Early Diagnosis and Risk Prediction of Hepatocellular Carcinoma in Patients With Chronic Liver Disease Based on a Digital Management Platform
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 15,000
- 试验地点
- 1
- 主要终点
- Early diagnosis rate of hepatocellular carcinoma (HCC)
研究概览
简要总结
Evaluating the effectiveness of standardized HCC risk stratification management in improving early diagnosis rates in patients with chronic liver disease
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntarily participate in the clinical study, fully understand and be informed of this study, sign the informed consent form, be willing to comply with and have the ability to complete all trial procedures.
- •Age between 18 and 75 years (inclusive)
- •Enrolled subjects must meet at least one of the following conditions: [1] Diagnosed with chronic hepatitis B virus infection via in-hospital or out-of-hospital pathways: Hepatitis B surface antigen (HBsAg) positive for 6 months or more; [2] Diagnosed with chronic hepatitis C virus infection via in-hospital or out-of-hospital pathways; [3] Subjects with a first-degree family history of hepatocellular carcinoma (first-degree relatives: parents, children, and full siblings);[4]Diagnosed with liver cirrhosis via in-hospital or out-of-hospital pathways, and meeting at least one of the following criteria: a) Liver biopsy showing cirrhosis (Ishak score ≥ 5 or Metavir score = 4); b) Liver Stiffness Measurement (LSM) assessed by FibroScan ® (Echosens™, Paris, France) ≥ 12.0 kPa with normal total bilirubin (TB) and ALT ≤ 40 IU/mL, or LSM ≥ 17.0 kPa with normal TB and ALT < 200 IU/mL; c) Abdominal imaging findings indicative of cirrhosis (i.e., liver with a coarse texture or with echoes or showing nodularity, parenchymal or morphological abnormalities, and signs of gastroesophageal varices); d) APRI score ≥ 2.0; e) FIB-4 index ≥ 3.25; [5] Diagnosed with metabolic dysfunction-associated fatty liver disease (MAFLD) via in-hospital or out-of-hospital pathways and with moderate liver fibrosis, specifically defined as a liver fibrosis score of F3 or above based on transient elastography, i.e., FibroScan® LSM ≥ 10 kPa or the corresponding threshold for FibroTouch® [24]; or non-invasive liver fibrosis index FIB-4 > 3.25; or NFS > 0.67; or APRI >
- •The diagnosis of metabolic dysfunction-associated fatty liver disease (MAFLD) requires evidence of >5% hepatic steatosis based on the Controlled Attenuation Parameter (CAP) from transient elastography, or similar parameters, or liver biopsy, concurrently with at least one of the following three conditions: overweight/obesity (BMI > 23 kg/m²), type 2 diabetes, or evidence of metabolic dysregulation. [6] Diagnosed with metabolic dysfunction-associated fatty liver disease (MAFLD) complicated by glucose metabolism abnormalities via in-hospital or out-of-hospital pathways: a) Glucose metabolism abnormality is defined as type 2 diabetes, or prediabetes indicated by fasting plasma glucose 5.6-6.9 mmol/L, or 2-hour postprandial glucose 7.8-11.0 mmol/L, or glycated hemoglobin (HbA1c) 5.7%-6.4%
排除标准
- •Age < 18 years or > 75 years
- •Suffering from severe mental illness or cognitive impairment
- •Pregnant or breastfeeding patients, or patients planning to become pregnant
- •Individuals who have participated in another clinical trial within the last 3 months or are currently participating in another clinical trial
- •Individuals deemed by the physician to have a low likelihood of enrollment (including inability to understand project requirements, poor compliance, frailty, inability to ensure the protocol can be followed as required, etc.), or those whom the physician considers to have other factors making them unsuitable for this trial
结局指标
主要结局
Early diagnosis rate of hepatocellular carcinoma (HCC)
时间窗: Through study completion, an average of 3 years
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.
次要结局
- Proportion of participants with regular follow-up(Through study completion, an average of 3 years)
研究者
Cai Qingxian
Chief of the Department of Hepatology
Shenzhen Third People's Hospital