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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00767936
First Posted: October 7, 2008
Last Update Posted: June 29, 2016
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.
Information provided by (Responsible Party):
Stanford University
  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

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • 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
blood

Enrollment: 135
Study Start Date: March 2008
Study Completion Date: September 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
liver cancer and non-cancer liver conditions
Criteria

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
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): NCT00767936


Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Samuel So Stanford University
  More Information

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT00767936     History of Changes
Other Study ID Numbers: HEP0013
98795 ( Other Identifier: Stanford University Alternate IRB Approval Number )
SU-05222008-1183 ( Other Identifier: Stanford University )
First Submitted: October 3, 2008
First Posted: October 7, 2008
Last Update Posted: June 29, 2016
Last Verified: June 2016

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Carcinoma, Hepatocellular
Hepatitis B
Liver Neoplasms
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Hepadnaviridae Infections
DNA Virus Infections


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