NCT00769730

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 29, 2008

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 9, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

August 4, 2009

Status Verified

July 1, 2009

Enrollment Period

1.1 years

First QC Date

September 29, 2008

Last Update Submit

August 2, 2009

Conditions

Hepatocellular CarcinomaHepatitis B Virus

Keywords

hepatocellular carcinomahepatitis B virustranscatheter arterial chemoembolization

Outcome Measures

Primary Outcomes (1)

  • HBV viral load

    3 months

Study Arms (1)

1

Patients with hepatocellular carcinoma caused by hepatitis B virus who will be treated by transcatheter arterial chemoembolization were included.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with hepatocellular carcinoma caused by hepatitis B virus who will be treated by transcatheter arterial chemoembolization

You may qualify if:

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

You may not qualify if:

  • patients already received antiviral drug management

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Medical University Hospital

Kaohsiung City, 807, Taiwan

Location

Biospecimen

Retention: SAMPLES WITH DNA

serum

MeSH Terms

Conditions

Carcinoma, HepatocellularHepatitis B

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver DiseasesBlood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitis

Study Officials

  • zu y lin, MD, Ms

    Kaohsiung Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 29, 2008

First Posted

October 9, 2008

Study Start

January 1, 2008

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

August 4, 2009

Record last verified: 2009-07

Locations

TW(1)