Relationship Between Polymorphism of Heat Shock Protein 7... | NCT00769535

Studies
Relationship Between Polymorphism of Heat Shock Protein 70 Gene and Hepatocellular Carcinoma

NCT00769535

Sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

Status

Completed

Last Update Posted

Apr 30, 2013Estimated

Enrollment

600Actual

Phase

Not Applicable

Conditions

Hepatocellular Carcinoma

Interventions

Polymorphisms of HSP70 and TNF promoter

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 2006

Primary Completion Date

Jun 2008Actual

Completion Date

Jun 2008Actual

First Submitted Date

Feb 26, 2008

First Submission Date that Met QC Criteria

Oct 7, 2008

First Posted Date

Oct 9, 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 26, 2013

Last Update Posted Date

Apr 30, 2013Estimated

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

Polymorphisms of HSP70 and tumor necrosis factor-alpha promoter in patients with hepatocellular carcinoma, chronic liver disease and healthy controls will be measured by PCR-RFLP or direct sequencing. The clinical relevance of patients will be compared in those with polymorphism and those without.

Detailed Description

Heat shock protein 70 (HSP 70) may be involved in various aspects of immune system including infection, autoimmunity, and tumor immunity. The relationship between HSP70 expression, disease activity and cancer prognosis varied according to type of cancer. The overexpression of HSP70 by tumor cells contributes to tumor behavior. HSP70 is present in normal and abnormal hepatocytes, and was reported to be over-expressed in both hepatoma cell lines and human hepatocellular carcinoma (HCC) tissue. Recent study indicated that HSP70 is a molecular marker during early hepatocarcinogenesis. It is also involved in anti-tumor immunity in HCC.We also investigate the polymorphism of tumor necrosis factor-alpha promoter, and correlated to clinical relevance.

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

600Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
HSP70 and TNF polymorphisms	Experimental		Genetic: Polymorphisms of HSP70 and TNF promoter

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Polymorphisms of HSP70 and TNF promoter	Genetic	To assess the relationship between clinical relevance and polymorphisms of HSP70 and tumor necrosis factor-alpha with PCR_RFLP

Measure	Description	Time Frame
Clinical relevance		year

Measure	Description	Time Frame
Clinical relevance		year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

History proven HCC patients

Exclusion Criteria:

No-definite diagnosed 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		Kaohsiung City	Kaohsiung	807	Taiwan
Kaohsiung Medical University

Condition Browse Module

MeSH Terms

ID	Term
D006528	Carcinoma, Hepatocellular

Ancestor Terms

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided