Chronic Hepatitis B Clinical Trial
Official title:
Prospective Cohort Study of the Effect of Serum HBV DNA Level on Intrahepatic Recurrence in Locally Treatable, HBV-related HCC Patients
| NCT number | NCT00397540 |
| Other study ID # | 10-2006-001 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | October 2004 |
| Est. completion date | May 2011 |
| Verified date | March 2019 |
| Source | Seoul National University Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to evaluate the effect of serum hepatitis B virus (HBV) DNA level on intrahepatic recurrence in locally treatable hepatocellular carcinomas (HCCs) related with HBV.
| Status | Completed |
| Enrollment | 145 |
| Est. completion date | May 2011 |
| Est. primary completion date | May 2011 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 19 Years to 80 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Seoul National University Hospital | Seoul |
| Lead Sponsor | Collaborator |
|---|---|
| Seoul National University Hospital |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 1,3,5 Year-Disease Free Survival (or Recurrence Free Survival) | 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. | 1,3,5 year | |
| Secondary | Overall Survival | Overall Survival: Number of Participants who Died | through study completion, an average of 3 years |
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