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

Purpose

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

Condition	Intervention
Hepatocellular Carcinoma	Device: tumor maker interval shortly

Study Type:	Observational
Study Design:	Observational Model: Cohort
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Cancer

U.S. FDA Resources

Further study details as provided by Yonsei University:

Primary Outcome Measures:

the difference of curative treatments & survival rates [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

the difference of early detection rates of HCC between both groups [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	1000
Study Start Date:	June 2007
Estimated Study Completion Date:	June 2011
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
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 tumor maker interval every 3 month Other Name: tumor maker interval every 3 month

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

Eligibility

Ages Eligible for Study:	20 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Liver cirrhosis

Criteria

Inclusion Criteria:

LC

Exclusion Criteria:

previous HCC

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01277653

Locations

Korea, Republic of
Severance Hospital	Recruiting
Seoul, Seodaemun-gu, Korea, Republic of, 120-752
Contact: Myoung Ha Lee, MD +82-10-2506-7592 leemyoungha@yuhs.ac

Sponsors and Collaborators

Yonsei University

Severance Hospital

Investigators

Study Director:

Myoung HA LEE, MD

OFF

More Information

No publications provided

Responsible Party:	Do Young Kim, Department of Internal Medicine, Yonsei University College of Medicine
ClinicalTrials.gov Identifier:	NCT01277653 History of Changes
Other Study ID Numbers:	AFP-PIVKA
Study First Received:	January 14, 2011
Last Updated:	January 14, 2011
Health Authority:	Korea: Food and Drug Administration

Keywords provided by Yonsei University:

Hepatocellular carcinoma

Additional relevant MeSH terms:

Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma

Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on May 23, 2013