Viral & Host Factors Associated With Hepatitis B Virus-related Hepatocelluar Carcinoma
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Purpose
Adult liver cancer is the third leading cause of cancer deaths worldwide. The major risk factor for liver cancer is hepatitis B virus (HBV) infection. The purpose of the study is to sequence the HBV genome in patients with chronic HBV infection, and in patients with liver cancer resulting from chronic HBV infection. The goal is to identify mutations in the HBV genome that predisposes these high risk individuals to the development of liver cancer.
| Condition |
|---|
|
Liver Cancer Hepatitis B Hepatitis C Hepatobiliary Cancers Liver Hepatobiliary Cancers |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Viral and Host Factors Associated With Development of Hepatitis B Virus-related Hepatocellular Carcinoma |
- identify mutations in the hepatitis B virus genome that predisposes these high risk individuals to the development of liver cancer [ Time Frame: one time ] [ Designated as safety issue: No ]We will be using blood specimens collected through another protocol
Biospecimen Retention: Samples Without DNA
blood
| Estimated Enrollment: | 200 |
| Study Start Date: | March 2008 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
liver cancer and non-cancer liver conditions
Inclusion Criteria:1. Patients diagnosed with liver cancer based on biopsy or serum AFP level, associated with characteristic hypervascular liver tumors on triphasic spiral CT scan or MRI.
2. Patients with non-cancer liver conditions such as cirrhosis, adenoma, cholangioma, or nodular hyperplasia.
3. Patients with hepatitis B or hepatitis C viral infections not associated with liver cancer.
Exclusion Criteria:No other patients except those listed above will be recruited. Additionally, patients will be excluded if, upon looking through their medical records, information required for data analysis are missing.
Contacts and Locations| Contact: Mei-Sze Chua | (650) 724-3525 | mchua@stanford.edu |
| United States, California | |
| Stanford University School of Medicine | Recruiting |
| Stanford, California, United States, 94305 | |
| Contact: Mei-Sze Chua 650-724-3525 mchua@stanford.edu | |
| Contact: Cancer Clinical Trials Office (650) 498-7061 | |
| Principal Investigator: Samuel So | |
| Sub-Investigator: Mei-Sze Chua | |
| Principal Investigator: | Samuel So | Stanford University |
More Information
No publications provided
| Responsible Party: | Stanford University |
| ClinicalTrials.gov Identifier: | NCT00767936 History of Changes |
| Other Study ID Numbers: | HEP0013, 98795, SU-05222008-1183 |
| Study First Received: | October 3, 2008 |
| Last Updated: | December 5, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis B Hepatitis C Hepatitis, Viral, Human Carcinoma Liver Neoplasms Carcinoma, Hepatocellular Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Liver Diseases |
Digestive System Diseases Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Hepadnaviridae Infections DNA Virus Infections Flaviviridae Infections Digestive System Neoplasms Neoplasms by Site Adenocarcinoma |
ClinicalTrials.gov processed this record on June 18, 2013