Evaluation the Possible Influence of Transcatheter Arterial Chemoembolization on Hepatitis B Viral Replication
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Purpose
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.
| Condition |
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Hepatocellular Carcinoma Hepatitis B Virus |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Evaluation the Possible Influence of Transcatheter Arterial Chemoembolization on Hepatitis B Viral Replication |
- HBV viral load [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
serum
| Enrollment: | 25 |
| Study Start Date: | January 2008 |
| Study Completion Date: | February 2009 |
| Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
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1
Patients with hepatocellular carcinoma caused by hepatitis B virus who will be treated by transcatheter arterial chemoembolization were included.
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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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
patients with hepatocellular carcinoma caused by hepatitis B virus who will be treated by transcatheter arterial chemoembolization
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
Contacts and Locations| Taiwan | |
| Kaohsiung Medical University Hospital | |
| Kaohsiung, Taiwan, 807 | |
| Principal Investigator: | zu y lin, MD, Ms | Kaohsiung Medical University |
More Information
No publications provided
| Responsible Party: | Zu-Yau Lin/Kaohsiung Medical University Hospital, Kaohsiung Medical University Hospital |
| ClinicalTrials.gov Identifier: | NCT00769730 History of Changes |
| Other Study ID Numbers: | KMUH-IRB-960331 |
| Study First Received: | September 29, 2008 |
| Last Updated: | August 2, 2009 |
| Health Authority: | Taiwan: Department of Health |
Keywords provided by Kaohsiung Medical University Chung-Ho Memorial Hospital:
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hepatocellular carcinoma hepatitis B virus transcatheter arterial chemoembolization |
Additional relevant MeSH terms:
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Carcinoma Hepatitis Hepatitis A Hepatitis B Carcinoma, Hepatocellular Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Liver Diseases Digestive System Diseases Hepatitis, Viral, Human |
Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Hepadnaviridae Infections DNA Virus Infections Adenocarcinoma Liver Neoplasms Digestive System Neoplasms Neoplasms by Site |
ClinicalTrials.gov processed this record on May 19, 2013