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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


N/A
20 Years
75 Years
Open (Enrolling)
Both
Hepatocellular Carcinoma

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Trial Information

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


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


Inclusion Criteria:



- LC

Exclusion Criteria:

- previous HCC

Type of Study:

Observational

Study Design:

Observational Model: Cohort

Outcome Measure:

the difference of curative treatments & survival rates

Outcome Time Frame:

4 years

Safety Issue:

Yes

Principal Investigator

Myoung HA LEE, MD

Investigator Role:

Study Director

Investigator Affiliation:

OFF

Authority:

Korea: Food and Drug Administration

Study ID:

AFP-PIVKA

NCT ID:

NCT01277653

Start Date:

June 2007

Completion Date:

June 2011

Related Keywords:

  • Hepatocellular Carcinoma
  • Hepatocellular carcinoma
  • Carcinoma
  • Carcinoma, Hepatocellular

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