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

NCT ID: NCT01277653

Last Updated: 2011-01-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-06-30

Study Completion Date

2011-06-30

Brief Summary

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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

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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

Conditions

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Hepatocellular Carcinoma

Study Design

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Observational Model Type

COHORT

Study Groups

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PIVKA-II and AFP 6 months

PIVKA-II and AFP measurement every 6 months

No interventions assigned to this group

tumor maker interval every 6 month

tumor maker interval every 6 month

tumor maker interval shortly

Intervention Type DEVICE

tumor maker interval every 3 month

Interventions

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tumor maker interval shortly

tumor maker interval every 3 month

Intervention Type DEVICE

Other Intervention Names

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tumor maker interval every 3 month

Eligibility Criteria

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Inclusion Criteria

* LC

Exclusion Criteria

* previous HCC
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Severance Hospital

OTHER

Sponsor Role collaborator

Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Department of Internal Medicine, Yonsei University College of Medicine

Principal Investigators

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Myoung HA LEE, MD

Role: STUDY_DIRECTOR

OFF

Locations

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Severance Hospital

Seoul, Seodaemun-gu, South Korea

Site Status RECRUITING

Countries

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South Korea

Facility Contacts

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Myoung Ha Lee, MD

Role: primary

+82-10-2506-7592

Other Identifiers

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AFP-PIVKA

Identifier Type: -

Identifier Source: org_study_id

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