NCT00764140

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2007

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

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
7 months until next milestone

First Posted

Study publicly available on registry

October 1, 2008

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

April 18, 2013

Status Verified

April 1, 2013

Enrollment Period

3.2 years

First QC Date

February 26, 2008

Last Update Submit

April 17, 2013

Conditions

Hepatocellular Carcinoma

Keywords

tumor growth factor

Outcome Measures

Primary Outcomes (1)

  • mortality

    5 years

Secondary Outcomes (1)

  • distant metastasis

    5 years

Study Arms (2)

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

tumor growth factor concentrationBIOLOGICAL

spot urine or blood collection will be used to measure specific tumor growth factor

Also known as: urine concentration of tumor growth factor, serum concentration of tumor growth factor
1

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Histology proven HCC

You may not qualify if:

  • No definitely diagnosed tumor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Kaohsiung, 807, Taiwan

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood and/or urine

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Officials

  • Jung-Fa Tsai, M.D., Ph.D.

    Professor of Medine, Kaohsiung Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

February 26, 2008

First Posted

October 1, 2008

Study Start

January 1, 2007

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

April 18, 2013

Record last verified: 2013-04

Locations

TW(1)