Back to results

Genetic Polymorphisms of Interleukin-1B and TNF-A and HBV-Related Hepatocellular Carcinoma

Primary Purpose

Hepatitis B, Hepatocellular Carcinoma, Chronic Liver Disease

Status

Completed

Phase

Not Applicable

Locations

Taiwan

Study Type

Interventional

Intervention

Polymorphism of IL-1 beta and TNF-alpha

About this trial

This is an interventional basic science trial for Hepatitis B focused on measuring cytokine gene, hepatitis B, hepatocellular carcinoma, chronic liver disease

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

HBsAg-positive patients

Exclusion Criteria:

HBsAg-negative patients

Sites / Locations

Kaohsiung Medical University Chung-Ho Hospital
Kaohsiung Medical University Chung-Ho Memorial Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

cytokines were determined

Arm Description

prevalence of genetic polymorphisms of interleukin 1B was measured in HBV-related hepatocellular carcinoma

Outcomes

Primary Outcome Measures

cytokine polymorphisms increase risk for hepatocellular carcinoma

Secondary Outcome Measures

Full Information

NCT ID

NCT00629486

First Posted

February 26, 2008

Last Updated

April 17, 2013

Sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00629486

Brief Title

Genetic Polymorphisms of Interleukin-1B and TNF-A and HBV-Related Hepatocellular Carcinoma

Official Title

Genetic Polymorphisms of Interleukin-1B and TNF-A and HBV-Related Hepatocellular Carcinoma

Study Type

Interventional

2. Study Status

Record Verification Date

April 2013

Overall Recruitment Status

Completed

Study Start Date

January 2007 (undefined)

Primary Completion Date

May 2008 (Actual)

Study Completion Date

May 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

By detecting polymorphisms of IL-1β and TNF-α,this study aims to find the effects of cytokine gene polymorphisms(and their interaction) on susceptibility and severity of HBV-related HCC.

Detailed Description

Hepatitis B virus (HBV)infection is the major risk factor for chronic liver disease and hepatocellular carcinoma (HCC). Host immunogenetic factors contribute to HBV-associated liver damage and/or carcinogenesis. Variant cytokine alleles, including tumor necrosis factor-α(TNF-α)and interleukin-1β(IL-1β), might contribute to interindividual difference in inflammatory responses and account for heterogeneous disease outcome of infectious disease. By detecting polymorphisms of IL-1β and TNF-α,this study aims to find the effects of cytokine gene polymorphisms(and their interaction) on susceptibility and severity of HBV-related HCC.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatitis B, Hepatocellular Carcinoma, Chronic Liver Disease

Keywords

cytokine gene, hepatitis B, hepatocellular carcinoma, chronic liver disease

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

300 (Actual)

8. Arms, Groups, and Interventions

Arm Title

cytokines were determined

Arm Type

Experimental

Arm Description

prevalence of genetic polymorphisms of interleukin 1B was measured in HBV-related hepatocellular carcinoma

Intervention Type

Genetic

Intervention Name(s)

Polymorphism of IL-1 beta and TNF-alpha

Other Intervention Name(s)

polymorphism, TNF-alpha, interleukin-1L

Intervention Description

To analyze the role of polymorphisms of IL-1beta and TNF-alpha gene on risk of hepatitis B-related chronic liver disease and hepatocellular carcinoma

Primary Outcome Measure Information:

Title

cytokine polymorphisms increase risk for hepatocellular carcinoma

Time Frame

years

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: HBsAg-positive patients Exclusion Criteria: HBsAg-negative patients

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jung-Fa Tsai, M.D., Ph.D.

Organizational Affiliation

Professor of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Kaohsiung Medical University Chung-Ho Hospital

City

Kaohsiung

ZIP/Postal Code

807

Country

Taiwan

Facility Name

Kaohsiung Medical University Chung-Ho Memorial Hospital

City

Kaohsiung

ZIP/Postal Code

807

Country

Taiwan

12. IPD Sharing Statement

Learn more about this trial

Genetic Polymorphisms of Interleukin-1B and TNF-A and HBV-Related Hepatocellular Carcinoma

We'll reach out to this number within 24 hrs