Ignite Creation Date:
2024-05-06 @ 2:44 PM
Last Modification Date:
2024-10-26 @ 1:36 PM
Study NCT ID:
NCT04414956
Status:
RECRUITING
Last Update Posted:
2020-06-04
First Post:
2020-05-20
Brief Title:
Combining Biomarkers AFP AFP-L3 and PIVKA-II and Image Tools for Early Detection of Hepatocellular Carcinoma
Sponsor:
Korea University
Organization:
Korea University
Study Overview
Official Title:
Clinical Usefulness of Combining Biomarkers AFP AFP-L3 and PIVKA-II With Abdominal Sonography or Computed Tomography for Early Detection of Hepatocellular Carcinoma
Status:
RECRUITING
Status Verified Date:
2020-05
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:
In this study three biomarkers tests AFP AFP-L3 and PIVKA-II and abdominal sonography or CT scans are performed every 6 months to detect hepatocellular carcinoma HCC early in patients with cirrhosis a high-risk group of HCC The aim of this study is to confirm the early HCC diagnosis rate in patients with cirrhosis and compare the detection efficacy between tests
Detailed Description:
Early diagnosis of HCC is the most important factor in improving the prognosis of the disease A surveillance test for early diagnosis of HCC in Korea is to perform alfa fetoprotein AFP and abdominal sonography every 6-months in high-risk groups However the detection rate of HCC using AFP and abdominal sonography is very low There are several reports that the combination of the multiple biomarker tests including AFP AFP L3 and PIVKA-II increased the early HCC detection only one test Therefore in the surveillance test for HCC the combination of three tests with sonography would be helpful in the early diagnosis of HCC However there was few prospective large-scale studies about this issue
Compared with abdominal sonography contrast-enhanced CT or MRI is more useful in finding intrahepatic lesions of liver cirrhosis However there is no evidence data on combining sonoCT and biomarkers could improve the diagnosis for early HCC Thus it is essential to verify this prospectively in the real clinical practices to make recommendations based on a high level of evidence in the future The investigators are conducting a prospective study which examines three biomarker tests and sonography every six months and contrast-enhanced CT annually for HCC surveillance in patients with cirrhosis
Compared with abdominal sonography contrast-enhanced CT or MRI is more useful in finding intrahepatic lesions of liver cirrhosis However there is no evidence data on combining sonoCT and biomarkers could improve the diagnosis for early HCC Thus it is essential to verify this prospectively in the real clinical practices to make recommendations based on a high level of evidence in the future The investigators are conducting a prospective study which examines three biomarker tests and sonography every six months and contrast-enhanced CT annually for HCC surveillance in patients with cirrhosis
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