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Trial Title:
Evaluation of Proteome Multimarker Panel With Multiple Reaction Monitoring as a Surveillance for Hepatocellular Carcinoma
NCT ID:
NCT05756699
Condition:
Liver Cirrhosis
Conditions: Official terms:
Carcinoma, Hepatocellular
Liver Cirrhosis
Study type:
Observational
Overall status:
Active, not recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
multiple reaction monitoring (MRM)-based multimarker panel
Description:
multiple reaction monitoring (MRM)-based multimarker panel test to detect hepatocellular
carcinoma
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.
Criteria for eligibility:
Study pop:
Patients with liver cirrhosis who receive regular surveillance for hepatocellular
carcinoma.
Sampling method:
Non-Probability Sample
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Seoul National University Hospital
Address:
City:
Seoul
Country:
Korea, Republic of
Start date:
April 10, 2023
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Seoul National University Hospital
Agency class:
Other
Collaborator:
Agency:
Seoul National University
Agency class:
Other
Source:
Seoul National University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05756699
