Study of PIVKA-II and AFP Measurement in Surveillance Program for Early Detection of Hepatocellular Carcinoma

• Conditions: Hepatocellular Carcinoma

• Registration Number: NCT01277653
• Lead Sponsor: Yonsei University

Brief Summary

There is no prospective study on the test intervals of alpha-fetoprotein (AFP) or on the role of prothrombin induced vitamin K absence or antagonist-II (PIVKA-II) in surveillance program for early detection of hepatocellular carcinoma(HCC). The goal of this study is to compare if the testing of AFP + PIVKA-II in intervals of 3 months is more effective in diagnosing early stages of HCC than the 6 month interval of AFP that is commonly used

Detailed Description

There is no prospective study on the test intervals of alpha-fetoprotein (AFP) or on the role of prothrombin induced vitamin K absence or antagonist-II (PIVKA-II) in surveillance program for early detection of hepatocellular carcinoma(HCC). The goal of this study is to compare if the testing of AFP + PIVKA-II in intervals of 3 months is more effective in diagnosing early stages of HCC than the 6 month interval of AFP that is commonly used

Study Timeline

• Study Start: 2007-06
• Status Verified: 2009-09
• Primary Completion: 2010-06
• Study First Submitted: 2011-01-14
• Study First Submitted QC: 2011-01-14
• Last Update Submitted: 2011-01-14
• Study First Posted: 2011-01-17
• Last Update Posted: 2011-01-17
• Study Completion: 2011-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• LC

Exclusion Criteria

• previous HCC

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the difference of curative treatments & survival rates	4 years

Secondary Outcome Measures

Name	Time	Method
the difference of early detection rates of HCC between both groups	4 years

Trial Locations

Locations (1)

Severance Hospital; 🇰🇷 Seoul, Seodaemun-gu, Korea, Republic of