NCT00629486

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2007

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 26, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 6, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

April 18, 2013

Status Verified

April 1, 2013

Enrollment Period

1.3 years

First QC Date

February 26, 2008

Last Update Submit

April 17, 2013

Conditions

Hepatitis BHepatocellular CarcinomaChronic Liver Disease

Keywords

cytokine genehepatitis Bhepatocellular carcinomachronic liver disease

Outcome Measures

Primary Outcomes (1)

  • cytokine polymorphisms increase risk for hepatocellular carcinoma

    years

Study Arms (1)

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

Polymorphism of IL-1 beta and TNF-alphaGENETIC

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

Also known as: polymorphism, TNF-alpha, interleukin-1L
cytokines were determined

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • HBsAg-positive patients

You may not qualify if:

  • HBsAg-negative patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Kaohsiung Medical University Chung-Ho Hospital

Kaohsiung City, Kaohsiung, 807, Taiwan

Location

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Kaohsiung, 807, Taiwan

Location

MeSH Terms

Conditions

Hepatitis BCarcinoma, Hepatocellular

Interventions

Tumor Necrosis Factor-alphaPolymorphism, Genetic

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by Site

Intervention Hierarchy (Ancestors)

GlycoproteinsGlycoconjugatesCarbohydratesMonokinesCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsTumor Necrosis FactorsBlood ProteinsProteinsBiological FactorsGenetic VariationGenetic Phenomena

Study Officials

  • Jung-Fa Tsai, M.D., Ph.D.

    Professor of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

February 26, 2008

First Posted

March 6, 2008

Study Start

January 1, 2007

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

April 18, 2013

Record last verified: 2013-04

Locations

TW(2)