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

This study has been terminated.
(lack of progress)
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT00767936
First received: October 3, 2008
Last updated: October 9, 2013
Last verified: October 2013
  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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

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: October 9, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Carcinoma
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis C
Liver Neoplasms
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
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 August 26, 2014