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Evaluation the Possible Influence of Transcatheter Arterial Chemoembolization on Hepatitis B Viral Replication

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ClinicalTrials.gov Identifier: NCT00769730
Recruitment Status : Completed
First Posted : October 9, 2008
Last Update Posted : August 4, 2009
Sponsor:
Information provided by:
Kaohsiung Medical University Chung-Ho Memorial Hospital

Tracking Information
First Submitted Date September 29, 2008
First Posted Date October 9, 2008
Last Update Posted Date August 4, 2009
Study Start Date January 2008
Actual Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 7, 2008)
HBV viral load [ Time Frame: 3 months ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Evaluation the Possible Influence of Transcatheter Arterial Chemoembolization on Hepatitis B Viral Replication
Official Title Evaluation the Possible Influence of Transcatheter Arterial Chemoembolization on Hepatitis B Viral Replication
Brief Summary Transcatheter arterial chemoembolization (TACE) is the traditional method for the palliative management of patients with hepatocellular carcinoma (HCC). Few previous studies had demonstrated that the serum level of anticancer drug from patients treated by TACE was similar to those treated by systemic chemotherapy. Since systemic chemotherapy may have the possibility to influence patient's general defense ability, hepatitis B virus may reactivate after chemotherapy.This study is to investigate the possibility of TACE in the reactivation of hepatitis B virus.
Detailed Description Hepatocellular carcinoma (HCC) is the most common malignant tumor of the liver. Chronic hepatitis B infection is the common etiology for the development of HCC. Transcatheter arterial chemoembolization (TACE) is the traditional method for the palliative management of patients with HCC. Few previous studies had demonstrated that the serum level of anticancer drug from patients treated by TACE was similar to those treated by systemic chemotherapy. Since systemic chemotherapy may have the possibility to influence patient's general defense ability, hepatitis B virus may reactivate after chemotherapy. There is no study to investigate the possibility of TACE in the reactivation of hepatitis B virus. This project will collect 20 patients with HCC caused by hepatitis B who are planned to be treated by TACE. Quantitative determination of viral load in blood will be performed before TACE, the first and the third month after TACE to investigate the influence of TACE on hepatitis B virus replication. This study will not influence the doctor's decision in the management of HCC and the procedure of TACE. The serum used for HBV DNA examination is concomitantly obtained during regular blood sampling for TACE preparation and follow-up of patient. The amount of blood needed for each time HBV DNA examination is less than 10 ml.
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
serum
Sampling Method Non-Probability Sample
Study Population patients with hepatocellular carcinoma caused by hepatitis B virus who will be treated by transcatheter arterial chemoembolization
Condition
  • Hepatocellular Carcinoma
  • Hepatitis B Virus
Intervention Not Provided
Study Groups/Cohorts 1
Patients with hepatocellular carcinoma caused by hepatitis B virus who will be treated by transcatheter arterial chemoembolization were included.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 2, 2009)
25
Original Estimated Enrollment
 (submitted: October 7, 2008)
20
Actual Study Completion Date February 2009
Actual Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • patients with hepatocellular carcinoma caused by hepatitis B virus without antiviral drug treatment and patients will be treated by transcatheter arterial chemoembolization

Exclusion Criteria:

  • patients already received antiviral drug management
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number NCT00769730
Other Study ID Numbers KMUH-IRB-960331
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Zu-Yau Lin/Kaohsiung Medical University Hospital, Kaohsiung Medical University Hospital
Study Sponsor Kaohsiung Medical University Chung-Ho Memorial Hospital
Collaborators Not Provided
Investigators
Principal Investigator: zu y lin, MD, Ms Kaohsiung Medical University
PRS Account Kaohsiung Medical University Chung-Ho Memorial Hospital
Verification Date July 2009