Tumor Growth Factors in Hepatocellular Carcinoma | NCT00764140

Studies
Tumor Growth Factors in Hepatocellular Carcinoma

NCT00764140

Sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

Status

Completed

Last Update Posted

Apr 18, 2013Estimated

Enrollment

400Actual

Phase

Not provided

Conditions

Hepatocellular Carcinoma

Interventions

tumor growth factor concentration

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

Apr 2010Actual

Completion Date

Apr 2010Actual

First Submitted Date

Feb 26, 2008

First Submission Date that Met QC Criteria

Sep 29, 2008

First Posted Date

Oct 1, 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

Malignant cells frequently produce many tumor growth factors to autocidal or endocrinal proliferate growth, metastasis,or angiogenesis about tumor cells. By studying tumor growth factors in hepatocellular carcinoma, one may know the tumor behavior, its relationship with clinical manifestation or invasion, and could be used as diagnostic or prognostic tools.This study aims to study the relationship between tumor growth factors in HCC ant its clinical relevance.

Detailed Description

The clinical relevance of patients will be evaluated by the concentrations of tumor growth factors.

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

Retention

Enrollment

400Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
2		Specific tumor growth factors (IGFs, its binding proteins,receptors; transforming growth factor alpha and beta 1 and epidermal growth factor) in the urine and serum will be measured in patients with hepatocellular carcinoma and healthy controls
1		Patients with hepatocellular carcinoma and Healthy controls	Biological: tumor growth factor concentration

Interventions

Name	Type	Description	Arm Group Labels	Other Names
tumor growth factor concentration	Biological	spot urine or blood collection will be used to measure specific tumor growth factor	1

Measure	Description	Time Frame
mortality		5 years

Measure	Description	Time Frame
distant metastasis		5 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Histology proven HCC

Exclusion Criteria:

No definitely diagnosed tumor

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

Patients with aspiration cytology or biopsy proved HCC and sex- and age-matched healthy controls.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jung-Fa Tsai, M.D., Ph.D.	Professor of Medine, Kaohsiung Medical University	Principal Investigator

Locations

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

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