Evaluation of Proteome Multimarker Panel With Multiple Reaction Monitoring as a Surveillance for Hepatocellular Carcinoma
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
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Study Design
Outcome Measures
Primary Outcome Measures
- HCC detection rate [Up to 2 years]
HCC detection using each surveillance modality/Total HCC cases
Secondary Outcome Measures
- Early HCC detection rate [Up to 2 years]
Early HCC (BCLC stage 0 or 1) detection using each surveillance modality/Total early HCC cases
- False referral rate [Up to 2 years]
False-positive case of each surveillance modality/Total false-positive and false-negative results
- Positive predictive value [Up to 2 years]
True-positive case of each surveillance modality/Total positive cases
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients with liver cirrhosis aged over 18 years, who receive regular surveillance for hepatocellular carcinoma.
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Patients with Risk Index greater than 2.33, corresponding to the annual 5% risk of hepatocellular carcinoma development.
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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).
Exclusion Criteria:
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History of malignancy diagnosis including hepatocellular carcinoma
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Impaired renal function (Estimated glomerular filtration rate <30 mL/min/1.73m2)
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Impaired hepatic function (Child-Pugh class C)
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Patients who are not eligible for voluntary consent
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Seoul National University Hospital
- Youngsoo Kim, Ph.D., Department of Biomedical Engineering, Seoul National University College of Medicine
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SNUH 2301-011-1391