Effect of Polymorphisms in the IL-1 Gene Complex on the D... | NCT00155103

Studies
Effect of Polymorphisms in the IL-1 Gene Complex on the Development of Chronic Hepatitis and Hepatocellular Carcinoma

NCT00155103

Sponsor

National Taiwan University Hospital

Status

Unknown status

Last Update Posted

Mar 21, 2007Estimated

Enrollment

1,600

Phase

Not provided

Conditions

Hepatitis B
Carcinoma, Hepatocellular
Polymorphism, Genetic

Interventions

Not provided

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

ID	Type	Description	Link
NSC 93-2314-B-002-226

Status Module

Record Verification Date

Jul 2005

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2004

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Sep 9, 2005

First Submission Date that Met QC Criteria

Sep 9, 2005

First Posted Date

Sep 12, 2005Estimated

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

Mar 20, 2007

Last Update Posted Date

Mar 21, 2007Estimated

Name	Class
National Science and Technology Council, Taiwan	OTHER_GOV

Description Module

Brief Summary

The purpose of this study is to determine the effect of polymorphisms in the IL-1 gene complex on the development of chronic hepatitis and hepatocellular carcinoma.

Detailed Description

We analyzed single-nucleotide polymorphisms in the genes for interleukin-1a, interleukin-1b, interleukin-1-receptor antagonist, interleukin-1-receptor type I, and interleukin-1-receptor type II in 400 normal control and patients (chronic hepatitis and hepatocellular carcinoma). Genotypes were tested for an association with development of chronic hepatitis and hepatocellular carcinoma by multivariable analysis. A second cohort of 1200 normal control and patients (chronic hepatitis and hepatocellular carcinoma) was independently analyzed for the genotype associations identified in the first cohort.

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,600

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Normal controls
Cases of chronic hepatitis and hepatocellular carcinoma

Exclusion Criteria:

Pregnant women

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Li-Hui Tseng, M.D., Ph.D.	Contact	+886-2-2312-3456	7437	htseng@ha.mc.ntu.edu.tw
Fang-Yu Chan, B.A.	Contact	+886-2-2312-3456	7440	p93448006@ntu.edu.tw

Overall Officials

Name	Affiliation	Role
Li-Hui Tseng, M.D., Ph.D.	National Taiwan University Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Medical Genetics; National Taiwan University Hospital	Recruiting	Taipei	Taipei	100	Taiwan

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