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Active, Not Recruiting

NCT Number: NCT05756699

Evaluation of Proteome Multimarker Panel With Multiple Reaction Monitoring as a Surveillance for Hepatocellular Carcinoma

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Liver Cirrhosis Digestive System Diseases Fibrosis Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul National University Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

multiple reaction monitoring (MRM)-based multimarker panel

Diagnostic Test

multiple reaction monitoring (MRM)-based multimarker panel test to detect hepatocellular carcinoma

Primary outcomes

  1. HCC detection rate

    Time frame: Up to 2 years

    HCC detection using each surveillance modality/Total HCC cases

Secondary outcomes

  1. Early HCC detection rate

    Time frame: Up to 2 years

    Early HCC (BCLC stage 0 or 1) detection using each surveillance modality/Total early HCC cases

  2. False referral rate

    Time frame: Up to 2 years

    False-positive case of each surveillance modality/Total false-positive and false-negative results

  3. Positive predictive value

    Time frame: Up to 2 years

    True-positive case of each surveillance modality/Total positive cases

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Seoul National University

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Mar 6, 2023
Registry last updated
May 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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