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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2009 by Yonsei University.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01277653
First Posted: January 17, 2011
Last Update Posted: January 17, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Severance Hospital
Information provided by:
Yonsei University
  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

Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • the difference of curative treatments & survival rates [ Time Frame: 4 years ]

Secondary Outcome Measures:
  • the difference of early detection rates of HCC between both groups [ Time Frame: 4 years ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Liver cirrhosis
Criteria

Inclusion Criteria:

  • LC

Exclusion Criteria:

  • previous HCC
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: January 14, 2011
First Posted: January 17, 2011
Last Update Posted: January 17, 2011
Last Verified: September 2009

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