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| Name | Class |
|---|---|
| Seoul National University | OTHER |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| multiple reaction monitoring (MRM)-based multimarker panel | Diagnostic Test | multiple reaction monitoring (MRM)-based multimarker panel test to detect hepatocellular carcinoma |
| Measure | Description | Time Frame |
|---|---|---|
| HCC detection rate | HCC detection using each surveillance modality/Total HCC cases | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Early HCC detection rate | Early HCC (BCLC stage 0 or 1) detection using each surveillance modality/Total early HCC cases | Up to 2 years |
| False referral rate | False-positive case of each surveillance modality/Total false-positive and false-negative results |
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Inclusion Criteria:
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.
Exclusion Criteria:
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Patients with liver cirrhosis who receive regular surveillance for hepatocellular carcinoma.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | South Korea |
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After obtaining informed consent, a total of 40 cc of blood will be obtained from patients (20 cc x 2 times).
| Up to 2 years |
| Positive predictive value | True-positive case of each surveillance modality/Total positive cases | Up to 2 years |
| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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