CClinicalTrials.gg
Status unknownNCT01277653Updated Jan 17, 2011

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

An observational study in Hepatocellular Carcinoma, sponsored by Yonsei University. Status unknown at 1 site in Korea, Republic of. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2011-01-17.

Sponsored by Yonsei University · Observational

The sponsor has not verified this record recently (last verified Sep 2009), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Enrollment
1,000
Ages
20 Years to 75 Years
Sex
All
01

Study 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

Read the 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

02

Conditions studied

  • Hepatocellular Carcinoma

Keywords

  • Hepatocellular carcinoma
03

In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,163 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 149 across 1,175 observational studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Yonsei University is the lead sponsor of 1,387 studies on the registry; 232 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Liver cirrhosis

Inclusion criteria

  • LC

Exclusion criteria

Exclusion Criteria:

  • previous HCC
05

Study design

Observational model
Cohort
Enrollment
1,000 participants (estimated)

Groups and cohorts

  • PIVKA-II and AFP 6 months

    PIVKA-II and AFP measurement every 6 months

  • tumor maker interval every 6 month

    tumor maker interval every 6 month

    Device: tumor maker interval shortly

Interventions

  • Devicetumor maker interval shortly

    tumor maker interval every 3 month

    Also known as: tumor maker interval every 3 month

06

What researchers measure

Primary outcomes

  1. the difference of curative treatments & survival rates

    Time frame: 4 years

Secondary outcomes

  1. the difference of early detection rates of HCC between both groups

    Time frame: 4 years

07

Study locations

1 of 1 sites recruiting
  • Severance Hospital
    Seoul, Seodaemun-gu 120-752, Korea, Republic of
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 17, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01277653
Lead sponsor
Yonsei University
Collaborators
Severance Hospital
First posted
Jan 17, 2011
Start date
Jun 2007
Primary completion
Jun 2010 (estimated)
Completion
Jun 2011 (estimated)
Last update
Jan 17, 2011

Study contacts

Myoung HA LEE, MD
study director · OFF

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2009. You cannot join it, but the record below documents what was studied.

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