A Prospective Study Evaluating the Accuracy of Proteome Multimarker Panel With Multiple Reaction Monitoring vs. Ultrasonography and Serum AFP as a Surveillance for Hepatocellular Carcinoma in High-Risk Population
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- HCC detection rate
研究概览
简要总结
Most current guidelines recommend hepatocellular carcinoma (HCC) surveillance with ultrasound and alpha feto-protein (AFP) every 6 months for individuals with risk factors. However, the sensitivity of ultrasound for HCC detection is significantly reduced, especially in high-risk cirrhotic patients. In this study, the investigators aim to evaluate the efficacy of multiple reaction monitoring (MRM)-based multimarker panel as a surveillance tool for HCC. During two surveillance periods (starting from the time of voluntary consent and 6 months later), participants receive ultrasound, AFP, and MRM-based multimarker panel analysis. Patients who are suspected of HCC based on one of three tests undergo a contrast-enhanced CT scan within 6 weeks. After 6 months from the second surveillance period, the investigators re-evaluate the development of HCC using contrast-enhanced CT and AFP. The diagnostic accuracy of MRM-based multimarker panel is compared to ultrasound and AFP.
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 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with liver cirrhosis aged over 18 years, who receive regular surveillance for hepatocellular carcinoma.
- •Patients with Risk Index greater than 2.33, corresponding to the annual 5% risk of hepatocellular carcinoma development.
- •Risk Index = 1.65 (if the prothrombin activity was ≤ 75%) + 1.41 (if the age was 55 years or older) + 0.92 (if the platelet count was < 75 X103/mm3) + 0.74 (if the presence of anti-hepatitis C virus was positive).
排除标准
- •History of malignancy diagnosis including hepatocellular carcinoma
- •Impaired renal function (Estimated glomerular filtration rate <30 mL/min/1.73m2)
- •Impaired hepatic function (Child-Pugh class C)
- •Patients who are not eligible for voluntary consent
结局指标
主要结局
HCC detection rate
时间窗: Up to 2 years
HCC detection using each surveillance modality/Total HCC cases
次要结局
- Early HCC detection rate(Up to 2 years)
- False referral rate(Up to 2 years)
- Positive predictive value(Up to 2 years)
研究者
Jeong-Hoon Lee
Professor
Seoul National University Hospital
