The Effect of Viral Load on Intrahepatic Recurrence in Hepatitis B Virus-Related Hepatocellular Carcinoma

This study is currently recruiting participants.

Verified by Seoul National University Hospital, November 2008

Sponsored by:	Seoul National University Hospital
Information provided by:	Seoul National University Hospital
ClinicalTrials.gov Identifier:	NCT00397540

Purpose

The purpose of this study is to evaluate the effect of serum HBV DNA level on intrahepatic recurrence in locally treatable HCCs related with HBV.

Condition	Phase
Carcinoma, Hepatocellular Hepatitis B Virus	Phase III

MedlinePlus related topics: Hepatitis Hepatitis B

Drug Information available for: Hepatitis B Vaccines

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Prospective Cohort Study of the Effect of Serum HBV DNA Level on Intrahepatic Recurrence in Locally Treatable, HBV-Related HCC Patients

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:

Survival - Disease free survival rate Recurrence - Cumulative recurrence rate [ Time Frame: 1,3,5-year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Survival - overall survival rate [ Time Frame: 1,3,5-year ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples With DNA

Biospecimen Description:

whole blood, serum

Estimated Enrollment:	100
Study Start Date:	October 2006
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Groups/Cohorts
local ablation HBV DNA > 10^5 copies/mL and HBV DNA < 10^5 copies/mL

Detailed Description:

Prospective cohort study

Survival

Overall survival rate
Disease free survival rate

Recurrence

Cumulative recurrence rate

Eligibility

Ages Eligible for Study:	19 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

single center HCC patients (Seoul National University Hospital)

Criteria

Inclusion Criteria:

Child-Pugh Class A or B
Maximal tumor size less than 5 cm
No previous history of treatment for hepatocellular carcinoma
Recurrent hepatocellular carcinoma located more than 2 cm from the previous cancer site and is found more than 1 year's gap

Exclusion Criteria:

Hepatocellular carcinoma in portal vein
Hepatocellular carcinoma in hepatic vein

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00397540

Contacts

Contact: Won Kim, Professor

82-2-740-8112

drwonlove@hotmail.com

Locations

Korea, Republic of
Seoul National University Hospital	Recruiting
Seoul, Korea, Republic of, 110-744

Sponsors and Collaborators

Seoul National University Hospital

Investigators

Study Director:

Won Kim, Professor

Seoul National University Hospital

More Information

Responsible Party:	Seoul National University Hospital ( Won Kim )
Study ID Numbers:	10-2006-001
Study First Received:	November 7, 2006
Last Updated:	November 5, 2008
ClinicalTrials.gov Identifier:	NCT00397540
Health Authority:	Korea: Food and Drug Administration

Keywords provided by Seoul National University Hospital:

HBV DNA
HCC
recurrence
PEIT
RFA

Study placed in the following topic categories:

Liver Diseases
Digestive System Neoplasms
Carcinoma, Hepatocellular
Liver neoplasms
Hepatitis, Viral, Human
Recurrence
Carcinoma
Hepatitis
Virus Diseases

Liver Neoplasms
Digestive System Diseases
Hepatitis B
Gastrointestinal Neoplasms
DNA Virus Infections
Adenocarcinoma
Hepatocellular carcinoma
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Disease Attributes
Neoplasms
Pathologic Processes

Neoplasms by Site
Neoplasms by Histologic Type
Hepadnaviridae Infections

ClinicalTrials.gov processed this record on January 14, 2009