Ignite Creation Date:
2024-05-06 @ 6:42 PM
Last Modification Date:
2024-10-26 @ 2:53 PM
Study NCT ID:
NCT05756699
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-18
First Post:
2023-02-20
Brief Title:
Evaluation of Proteome Multimarker Panel With Multiple Reaction Monitoring as a Surveillance for Hepatocellular Carcinoma
Sponsor:
Seoul National University Hospital
Organization:
Seoul National University Hospital
Study Overview
Official 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
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None