NCT01277653

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 14, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 17, 2011

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

January 17, 2011

Status Verified

September 1, 2009

Enrollment Period

3 years

First QC Date

January 14, 2011

Last Update Submit

January 14, 2011

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular carcinoma

Outcome Measures

Primary Outcomes (1)

  • the difference of curative treatments & survival rates

    4 years

Secondary Outcomes (1)

  • the difference of early detection rates of HCC between both groups

    4 years

Study Arms (2)

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

tumor maker interval shortlyDEVICE

tumor maker interval every 3 month

Also known as: tumor maker interval every 3 month
tumor maker interval every 6 month

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Liver cirrhosis

You may not qualify if:

  • previous HCC

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severance Hospital

Seoul, Seodaemun-gu, 120-752, South Korea

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Officials

  • Myoung HA LEE, MD

    OFF

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 14, 2011

First Posted

January 17, 2011

Study Start

June 1, 2007

Primary Completion

June 1, 2010

Study Completion

June 1, 2011

Last Updated

January 17, 2011

Record last verified: 2009-09

Locations

KR(1)