Prospective Cohort Study of the Effect of Serum HBV DNA Level on Intrahepatic Recurrence in Locally Treatable, HBV-related HCC Patients
19 Years
80 Years
Both
Carcinoma, Hepatocellular, Hepatitis B Virus
Trial Information
Prospective Cohort Study of the Effect of Serum HBV DNA Level on Intrahepatic Recurrence in Locally Treatable, HBV-related HCC Patients
Prospective cohort study
Survival
- Overall survival rate
- Disease free survival rate
Recurrence
- Cumulative recurrence rate
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Disease Free Survival (or Recurrence Free Survival)
Outcome Description:
The disease free survival is defined as the total number of surviving participants without intrahepatic recurrence of hepatocellular carcinoma for 1, 3, and 5 years.
Outcome Time Frame:
1,3,5-year
Safety Issue:
No
Principal Investigator
Won Kim, Professor
Investigator Role:
Study Director
Investigator Affiliation:
Seoul National University Hospital
Authority:
Korea: Food and Drug Administration
Study ID:
10-2006-001
NCT ID:
NCT00397540
Start Date:
October 2006
Completion Date:
April 2013
Related Keywords:
- Carcinoma, Hepatocellular
- Hepatitis B Virus
- HBV DNA
- HCC
- recurrence
- PEIT
- RFTA
- Carcinoma
- Hepatitis
- Hepatitis A
- Hepatitis B
- Recurrence
- Carcinoma, Hepatocellular
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