Clinical trial · Observational
Evaluation of Proteome Multimarker Panel With Multiple Reaction Monitoring as a Surveillance for Hepatocellular Carcinoma
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Liver Cirrhosis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| multiple reaction monitoring (MRM)-based multimarker panel | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- HCC detection rate
- timeFrame
- Up to 2 years
- description
- HCC detection using each surveillance modality/Total HCC cases
Secondary outcomes (3)
- measure
- Early HCC detection rate
- timeFrame
- Up to 2 years
- description
- Early HCC (BCLC stage 0 or 1) detection using each surveillance modality/Total early HCC cases
- measure
- False referral rate
- timeFrame
- Up to 2 years
- description
- False-positive case of each surveillance modality/Total false-positive and false-negative results
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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. * 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: * 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
References
Publications (0)
Data not yet available