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

January 14, 2011 updated by: Yonsei University

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Seodaemun-gu
      • Seoul, Seodaemun-gu, Korea, Republic of, 120-752
        • Recruiting
        • Severance Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Liver cirrhosis

Description

Inclusion Criteria:

  • LC

Exclusion Criteria:

  • previous HCC

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
PIVKA-II and AFP 6 months
PIVKA-II and AFP measurement every 6 months
tumor maker interval every 6 month
Device: tumor maker interval shortly
tumor maker interval every 3 month
Other Names:
  • tumor maker interval every 3 month

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the difference of curative treatments & survival rates
Time Frame: 4 years
4 years

Secondary Outcome Measures

Outcome Measure
Time Frame
the difference of early detection rates of HCC between both groups
Time Frame: 4 years
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Collaborators

Severance Hospital

Investigators

  • Study Director: Myoung HA LEE, MD, OFF

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Anticipated)

June 1, 2010

Study Completion (Anticipated)

June 1, 2011

Study Registration Dates

First Submitted

January 14, 2011

First Submitted That Met QC Criteria

January 14, 2011

First Posted (Estimate)

January 17, 2011

Study Record Updates

Last Update Posted (Estimate)

January 17, 2011

Last Update Submitted That Met QC Criteria

January 14, 2011

Last Verified

September 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AFP-PIVKA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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