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To Study the Effects of Host Genetic Factors on Liver Cirrhosis and Hepatocellular Carcinoma (HCC)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
National Science Council, Taiwan
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00709085
First received: June 30, 2008
Last updated: November 23, 2009
Last verified: November 2009
History of Changes
  Purpose

The purpose of this study is to identify genetic determinants of susceptibility to liver cirrhosis and hepatocellular carcinoma. It will assist in predicting individual risks of disease progression and would help to clarify pathophysiologic mechanisms of liver cirrhosis and hepatocellular carcinoma.


Condition
Liver Cirrhosis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Functional Genomics and Proteomics Towards and Understanding of Cell Signaling and Diseases--- Genomic and Proteomic Analyses of Liver Cells During Hepatitis Virus Infections and Cell Therapy (4/4)

Resource links provided by NLM:

MedlinePlus related topics: Cirrhosis
U.S. FDA Resources

Further study details as provided by National Taiwan University Hospital:

Biospecimen Retention:   Samples With DNA

liver tissue (non-tumor part)


Estimated Enrollment: 320
Study Start Date: April 2008
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
HCC patients without liver cirrhosis
2
HCC patients with liver cirrhosis

Detailed Description:

Hepatocellular carcinoma (HCC) usually occurs in cirrhotic liver. Only 10-30% of HCC occur in non-cirrhotic liver. It has been suggested that etiological factors may differ for HCC which develop in cirrhotic liver: HCC in non-cirrhotic liver might be less often associated with viral infection and chronic alcoholism than HCC in cirrhotic livers. However, in any individual, the factors that determine HCC with or without cirrhosis remain unknown.

Cirrhosis is the end of fibrosis progression. The progress of liver fibrosis is a complex progress involving many cytokines related to activation of the hepatic stellate cells and progressive accumulation of extracellular matrix. The key enzymes responsible for deposition and degradation of all the protein component of extracellular matrix and basement membrane are matrix metalloproteinases.

To assess whether genetic variations in cytokines and matrix metalloproteinases result in diversity of liver cirrhosis and HCC, we conduct a case-control study of single nucleotide polymorphism analysis.

  Eligibility

Ages Eligible for Study:   50 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

A total of 596 patients with histologically proven HCC were collected by Dr. Po-Huang Lee's Lab. (The Department of Surgery, National Taiwan University Hospital, Taipei, Taiwan)

Criteria

Inclusion Criteria:

  • Clinical diagnosis of hepatocellular carcinoma
  • restrict the casual agent of liver disease to viral infection

Exclusion criteria:

  • the casual aget of liver disease is not viral infection, such as alcohol abuse
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00709085

Contacts
Contact: Tzu-Min Hung, M.S. 886-2-2312-3456 ext 88226 mean6722@ms65.hinet.net

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan
Contact: Ming-Fu Chang, Ph.D.     886-2-2312-3456 ext 88217     mfchang@ntu.edu.tw    
Principal Investigator: Ming-Fu Chang, Ph.D.            
Sponsors and Collaborators
National Taiwan University Hospital
National Science Council, Taiwan
Investigators
Study Chair: Ming-Fu Chang, Ph.D. National Taiwan University College of Medicine
  More Information

No publications provided

Responsible Party: Ming-Fu Chang, Ph.D., Proferrsor, Institute of Biochemistry and Molecular Biology, National Taiwan University
ClinicalTrials.gov Identifier: NCT00709085     History of Changes
Other Study ID Numbers: 200803038R
Study First Received: June 30, 2008
Last Updated: November 23, 2009
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
single nucleotide polymorphism

Additional relevant MeSH terms:
Liver Cirrhosis
Fibrosis
Carcinoma, Hepatocellular
Liver Diseases
Digestive System Diseases
Pathologic Processes
Adenocarcinoma
 Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on May 21, 2013