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

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)

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.

Study Overview

• Status: Unknown
• Conditions: 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
• Enrollment (Anticipated): 320

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Recruiting
    • National Taiwan University Hospital
    • Contact: Ming-Fu Chang, Ph.D.; Phone Number: 88217 886-2-2312-3456; Email: mfchang@ntu.edu.tw
    • Principal Investigator: Ming-Fu Chang, Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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)

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
1; HCC patients without liver cirrhosis
2; HCC patients with liver cirrhosis

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Collaborators: National Science Council, Taiwan
• Investigators: Study Chair: Ming-Fu Chang, Ph.D., National Taiwan University College of Medicine

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (ANTICIPATED): December 1, 2009
• Study Completion (ANTICIPATED): December 1, 2009

Study Registration Dates

• First Submitted: June 30, 2008
• First Submitted That Met QC Criteria: July 2, 2008
• First Posted (ESTIMATE): July 3, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): November 25, 2009
• Last Update Submitted That Met QC Criteria: November 23, 2009
• Last Verified: November 1, 2009

More Information

Terms related to this study

• Keywords: single nucleotide polymorphism
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Fibrosis; Liver Cirrhosis
• Other Study ID Numbers: 200803038R