Genetic Polymorphisms of Interleukin-1B and TNF-A and HBV... | NCT00629486

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

NCT00629486

Sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

Status

Completed

Last Update Posted

Apr 18, 2013Estimated

Enrollment

300Actual

Phase

Not Applicable

Conditions

Hepatitis B
Hepatocellular Carcinoma
Chronic Liver Disease

Interventions

Polymorphism of IL-1 beta and TNF-alpha

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2007

Primary Completion Date

May 2008Actual

Completion Date

May 2008Actual

First Submitted Date

Feb 26, 2008

First Submission Date that Met QC Criteria

Mar 5, 2008

First Posted Date

Mar 6, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 17, 2013

Last Update Posted Date

Apr 18, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jung-Fa,Tsai, Professor of Medicine, Kaohsiung Medical University Chung-Ho Memorial HospitalPrincipal Investigator

Lead Sponsor

Kaohsiung Medical University Chung-Ho Memorial HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

300Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
cytokines were determined	Experimental	prevalence of genetic polymorphisms of interleukin 1B was measured in HBV-related hepatocellular carcinoma	Genetic: Polymorphism of IL-1 beta and TNF-alpha

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Polymorphism of IL-1 beta and TNF-alpha	Genetic	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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
cytokine polymorphisms increase risk for hepatocellular carcinoma		years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

HBsAg-positive patients

Exclusion Criteria:

HBsAg-negative patients

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jung-Fa Tsai, M.D., Ph.D.	Professor of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kaohsiung Medical University Chung-Ho Hospital		Kaohsiung City	Kaohsiung	807	Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital

Condition Browse Module

MeSH Terms

ID	Term
D006509	Hepatitis B
D006528	Carcinoma, Hepatocellular

Ancestor Terms

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D018347	Hepadnaviridae Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014409	Tumor Necrosis Factor-alpha
D011110	Polymorphism, Genetic

Ancestor Terms

ID	Term
D006023	Glycoproteins
D006001	Glycoconjugates
D002241	Carbohydrates
D015846	Monokines

Browse Leaves

Not provided

Browse Branches

Not provided