Genetic Susceptibility to Oncogenic Viruses

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00341484
First received: June 19, 2006
Last updated: April 19, 2014
Last verified: April 2014
  Purpose

An NCI goal is to identify every human gene that predisposes people to cancer. Recent studies of HIV-1 indicate that genetic polymorphisms can affect susceptibility to viral infections and that such alleles may be racially restricted, a range of racial and ethnic groups should be included in such studies. We propose to examine genetic determinants of infection with hepatitis B virus (HBV) and hepatitis C virus (HCV) in an ethnically diverse population of injection drug users (IDUs). HBV and HCV are important causes of hepatocellular carcinoma, but little is known about genetic factors that alter susceptibility to these infections. Subjects will be recruited in diverse inner-city neighborhoods as part of the University of California, San Francisco's Urban Health Study. Since 1986, this study has successfully recruited and evaluated IDUs from street-based settings. About half of the participants are African-American, one-third are white, 10% are Latino, and the remainder are Asian or Native American. The mean duration of drug use exceeds 20 years. About 80% of subjects have evidence of HBV infection and a similar prevalence of HCV infections is anticipated. We will enroll about 1500 subjects over a 13 month period. Archived, unlinked serum specimens may be obtained from previous enrollees to increase the sample size, as needed. Highly exposed-uninfected subjects will be ascertained on the basis of the serologic testing for each virus, as well as the duration and frequency of injection drug use. These highly exposed-uninfected subjects will be compared to infected subjects with regard to their frequency of genetic polymorphisms (chemokines, chemokine receptors, human leukocyte antigens, and others), in collaboration with scientists from NCI's Laboratory of Genomic Diversity.


Condition
Liver Neoplasms
HIV Infections

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Genetic Susceptibility to Oncogenic Viruses

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Genetic determinants [ Designated as safety issue: No ]

Estimated Enrollment: 2600
Study Start Date: May 1998
Detailed Description:

An NCI goal is to identify every human gene that predisposes people to cancer. Recent studies of HIV -1 indicate that genetic polymorphisms can affect susceptibility to viral infections and that such alleles may be detected in studies of small numbers of highly exposed-uninfected subjects. Because such alleles may be racially restricted, a range of racial and ethnic groups should be included in such studies. We propose to examine genetic determinants of infection with hepatitis B virus (HBV) and hepatitis C virus (HCV) in an ethnically diverse population of injection drug users (lDUs). HBV and HCV are important causes of hepatocellular carcinoma, but little is known about genetic factors that alter susceptibility to these infections. Subjects will be recruited in diverse inner-city neighborhoods as part of the University of California, San Francisco's Urban Health Study. Since 1986, this study has successfully recruited and evaluated IDUs from street-based settings. About half of the participants are African-American, one-third are white, 10% are Latino, and the remainder are Asian or Native American. The mean duration of drug use exceeds 20 years. About 80% of subjects have evidence of HBV infection and a similar prevalence of HCV infection is anticipated. We will enroll about 1500 subjects over a 13 month period. Archived, unlinked serum specimens may obtained from previous enrollees to increase the sample size, as needed. Highly exposed-uninfected subjects will be ascertained on the basis of the serologic testing for each virus, as well as the duration and frequency of injection drug use. These highly exposed-uninfected subjects will be compared to infected subjects with regard to their frequency of genetic polymorphisms (chemokines, chemokine receptors, human leukocyte antigens, and others), in collaboration with scientists from NCI's Laboratory of Genomic Diversity.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

    18 years or older

Active IDU as verified by self-report and physical examination for visible signs consistent with multiple drug injection.

EXCLUSION CRITERIA:

Subject unable to give informed consent.

  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: NCT00341484

Locations
United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
Investigators
Principal Investigator: Thomas R O'Brien, M.D. National Cancer Institute (NCI)
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00341484     History of Changes
Other Study ID Numbers: 999998026, OH98-C-N026
Study First Received: June 19, 2006
Last Updated: April 19, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Genetics
Liver Cancer
HIV

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
Disease Susceptibility
Genetic Predisposition to Disease
HIV Infections
Liver Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Disease Attributes
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Liver Diseases
Neoplasms
Neoplasms by Site
Pathologic Processes
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on October 30, 2014