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

Prospective, Randomized Study of PIVKA-II and AFP Measurement Every 3 Months Compared to AFP Every 6 Months in Surveillance Program for Early Detection of Hepatocellular Carcinoma

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01277653

Enrollment

1000

Registered

2011-01-17

Start date

2007-06-30

Completion date

2011-06-30

Last updated

2011-01-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular carcinoma

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

Interventions

DEVICEtumor maker interval shortly

tumor maker interval every 3 month

Study design

Observational model

COHORT

Eligibility

Sex/Gender

ALL

Age

20 Years to 75 Years

Healthy volunteers

Inclusion criteria

* LC

Exclusion criteria

* previous HCC

Design outcomes

Primary

Measure	Time frame
the difference of curative treatments & survival rates	4 years

Secondary

Measure	Time frame
the difference of early detection rates of HCC between both groups	4 years

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026