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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Yonsei University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Severance Hospital
Information provided by:
Yonsei University
ClinicalTrials.gov Identifier:
NCT01277653
First received: January 14, 2011
Last updated: NA
Last verified: September 2009
History: No changes posted
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 29, 2014