Genetic Studies in Liver Cancer Patients

Hepatocellular Carcinoma Clinical Trial

Official title:

Identification of Differentially Expressed Genes in Hepatocellular Carcinoma With DNA Microarrays

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00172640
• Other study ID #: 9361701211
• Status: Recruiting
• Phase: Phase 1
• First received: September 12, 2005
• Last updated: September 12, 2005
• Start date: January 2005

Study information

• Verified date: December 2004
• Source: National Taiwan University Hospital
• Contact: Chien-Hung Chen, MD
• Phone: 886-2-23123456
• Email: chenhcc[@]ntumc.org
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical Trial Summary

Hepatocellular carcinoma (HCC) is one the most common malignancies in the world, especially in sub-Saharan Africa and Southeast Asia. Since 1984, it has been the leading cause of cancer death in Taiwan. About 6000-8000 people died of this cancer every year in Taiwan. DNA microarray (DNA chip) is a very powerful tool to clarify the genetic changes in cancers. Expression profiling techniques have been used to simultaneously monitor the expression of thousands of genes from human tumor samples. It has been successfully used to predict clinical outcome and survival as well as classify different types of cancer. In this study, we will use the DNA chip to study the genetics in liver cancer patients.

Description:

The clinical samples will be collected in the NTUH, while the DNA microarray works will be done in Biomedical Engineering Center (BMEC) of ITRI.

Patients A total of 40 cases of HCC patients (20 HBV-related HCC and 20 HCV-related HCC) who received surgical resection in National Taiwan University Hospital will be enrolled from our tissue banks. The diagnosis of HCC was confirmed by pathological examination. The surgical specimens were frozen immediately after surgery and stored in –140°C. The clinicopathological data will be retrospectively obtained from chart reviews.

Another total of 40 new HCC patients who receive surgical resection in National Taiwan University Hospital will be collected. The healthy subjects and patients chronically infected with HBV or HCV without HCC will be used as controls. The whole bloods will be collected before, one and six months after operation. The diagnosis of HCC will be confirmed by pathology. In addition to the whole bloods, the surgical specimens will be frozen immediately after surgery and stored in –140°C.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• hepatocellular carcinoma

Exclusion Criteria:

• multiple cancers

Study Design

Observational Model: Defined Population, Primary Purpose: Screening, Time Perspective: Longitudinal

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
National Taiwan University Hospital	Industrial Technology Research Institute, Taiwan

Country where clinical trial is conducted

Taiwan,