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

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ClinicalTrials.gov Identifier: NCT00709085
Recruitment Status : Unknown
Verified November 2009 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : July 3, 2008
Last Update Posted : November 25, 2009
National Science Council, Taiwan
Information provided by:
National Taiwan University Hospital

Brief Summary:
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 or disease
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.

Study Type : Observational
Estimated Enrollment : 320 participants
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)
Study Start Date : April 2008
Estimated Primary Completion Date : December 2009
Estimated Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cirrhosis
U.S. FDA Resources

HCC patients without liver cirrhosis
HCC patients with liver cirrhosis

Biospecimen Retention:   Samples With DNA
liver tissue (non-tumor part)

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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)

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00709085

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

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
Study Chair: Ming-Fu Chang, Ph.D. National Taiwan University College of Medicine

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
First Posted: July 3, 2008    Key Record Dates
Last Update Posted: November 25, 2009
Last Verified: November 2009

Keywords provided by National Taiwan University Hospital:
single nucleotide polymorphism

Additional relevant MeSH terms:
Liver Cirrhosis
Pathologic Processes
Liver Diseases
Digestive System Diseases