NCT05870969招募中不适用
Exploration of A Holistic Management Procedure for Liver Cancer Surveillance in Improving Liver Cancer's Early Diagnosis Efficacy in Chinese Population: Single-Center, Prospective, Observational Real-world Study in EASTERN China
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20,000
- 试验地点
- 1
- 主要终点
- Early diagnosis rate of HCC patients
研究概览
简要总结
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.
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
- •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
- •Patients diagnosed with hepatitis C in hospital or out of hospital
- •Patients diagnosed with cirrhosis in hospital or out of hospital who meet at least one of the following criteria.
- •Liver biopsy showing cirrhosis (Ishak score ≥5 or Metavir score = 4);
- •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;
- •Abdominal imaging results showing characteristic of cirrhosis (results showing coarse liver echotexture or nodular, parenchymal, or morphological abnormalities and signs of gastroesophageal varices);
- •APRI ≥ 2.0;
- •FIB-4 ≥ 3.25
- •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.
- •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%
- •Subjects with a family history of liver cancer in their first-degree biological relatives.
排除标准
- •Patients meeting any of the following criteria will be excluded from the study:
- •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
- •Patients who have participated in other clinical trials or are participating in other clinical trials within 3 months prior to initiation of study treatment
- •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
结局指标
主要结局
Early diagnosis rate of HCC patients
时间窗: 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.
次要结局
- 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)
- 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 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 distribution of risk stratification of liver cancer in subjects at initial screening(Initial screening after enrollment)
- Proportion of subjects with regular follow-up(Four years collectively after the study started)
研究者
Qing XIe
Director of Department of Infectious Diseases, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Ruijin Hospital
研究点 (1)
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