hepatocellular carcinoma
Conditions
Interventions
Intervention group 1:non-contrast abbreviated MRI and serum AFP test
Intervention group 2:enhanced abbreviated MRI and serum AFP test
Control group:ultrasound and serum AFP test
Sponsors
Peking University People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75; 2. According to the Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (2024 Edition) from department of medical administration, nation health commission of the People’s Republic of China, with any one of the following high-risk factors for liver cancer: hepatitis B and/or C virus infection, excessive alcohol consumption, hepatic steatosis or metabolic dysfunction-associated liver disease, dietary exposure to aflatoxin B1, liver cirrhosis from other causes, or a family history of liver cancer, and an aMAP score (age?male?albi?platelets score) of 60–100 points; 3. Liver disease patients with no evidence of suspected liver cancer in any imaging examination (liver US, contrast-enhanced CT, or contrast-enhanced MRI) within the past six months; 4. Signed informed consent form;
Exclusion criteria
Exclusion criteria: 1. History of previous liver cancer diagnosis; 2. Baseline screening at enrollment diagnosed with liver cancer; 3. Child-Pugh score >= 10 (class C); 4. History of other malignant tumors; 5. Pregnant or lactating women; 6. Clinically diagnosed severe heart/lung disease or uncontrolled comorbidities, with investigator-judged life expectancy < 2 years; 7. Glomerular filtration rate < 50 mL/min; 8. Inability to undergo (enhanced) MRI due to contraindications or relative contraindications; 9. Poor compliance or unsuitability for the clinical trial as judged by the investigator;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the proportion of early-stage (BCLC 0+A stage) HCC diagnoses at 18th month; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of early and very early-stage HCC detection, mortality rate, survival rate, and median survival time at 42th month;the proportion of very early stage (BCLC 0stage) HCC diagnoses at 18th month;Evaluate the incremental cost-effectiveness ratio (ICER) for early-stage hepatocellular carcinoma (HCC) detection.;Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV);Patient adherence and acceptability to the study protocol;The mortality rate, survival rate, and median survival time in HCC patients at 18th month; | — |
Countries
China
Contacts
Public ContactYi Wang
Peking University People's Hospital
Outcome results
None listed