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OpenTrials
Completed

NCT Number: NCT00397540

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

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.

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Key information

Conditions

Carcinoma, Hepatocellular Adenocarcinoma Blood-Borne Infections Carcinoma Chronic Disease Chronic Hepatitis B Communicable Diseases DNA Virus Infections Digestive System Diseases Digestive System Neoplasms Disease Attributes Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis B, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Virus Diseases

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, 110-744, South Korea

About this study

Prospective cohort study

Survival

  • Overall survival rate
  • Disease free survival rate

Recurrence

  • Cumulative recurrence rate

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PEIT

Procedure

Percutaneous Ethanol Injection Therapy

Other names: PEI, local ablation therapy

RFTA

Procedure

Radiofrequency Thermal Ablation

Other names: RFA, local ablation therapy

Primary outcomes

  1. 1,3,5 Year-Disease Free Survival (or Recurrence Free Survival)

    Time frame: 1,3,5 year

    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.

Secondary outcomes

  1. Overall Survival

    Time frame: through study completion, an average of 3 years

    Overall Survival: Number of Participants who Died

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

Prospective Cohort Study of the Effect of Serum HBV DNA Level on Intrahepatic Recurrence in Locally Treatable, HBV-related HCC Patients

Important dates

Study start
2004
Primary completion
2011
Study completion
2011
First posted
Nov 9, 2006
Registry last updated
Mar 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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