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Viral & Host Factors Associated With Hepatitis B Virus-related Hepatocellular Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00767936
Recruitment Status : Terminated
First Posted : October 7, 2008
Last Update Posted : June 29, 2016
Information provided by (Responsible Party):
Stanford University

Brief Summary:
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 or disease
Liver Cancer Hepatitis B Hepatitis C Hepatobiliary Cancers Liver Hepatobiliary Cancers

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Study Type : Observational
Actual Enrollment : 135 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Viral and Host Factors Associated With Development of Hepatitis B Virus-related Hepatocellular Carcinoma
Study Start Date : March 2008
Actual Primary Completion Date : March 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. identify mutations in the hepatitis B virus genome that predisposes these high risk individuals to the development of liver cancer [ Time Frame: one time ]
    We will be using blood specimens collected through another protocol

Biospecimen Retention:   Samples Without DNA

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.

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 identifier (NCT number): NCT00767936

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United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
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Principal Investigator: Samuel So Stanford University
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Responsible Party: Stanford University Identifier: NCT00767936    
Other Study ID Numbers: HEP0013
98795 ( Other Identifier: Stanford University Alternate IRB Approval Number )
SU-05222008-1183 ( Other Identifier: Stanford University )
First Posted: October 7, 2008    Key Record Dates
Last Update Posted: June 29, 2016
Last Verified: June 2016
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis B
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Hepadnaviridae Infections
DNA Virus Infections