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临床试验/NCT05756699
NCT05756699进行中(未招募)不适用

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

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2023年4月10日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jeong-Hoon Lee

Professor

Seoul National University Hospital

研究点 (1)

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