Viewing Study NCT00341484



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Last Modification Date: 2024-10-26 @ 9:25 AM
Study NCT ID: NCT00341484
Status: COMPLETED
Last Update Posted: 2020-06-16
First Post: 2006-06-19

Brief Title: Genetic Susceptibility to Oncogenic Viruses
Sponsor: National Cancer Institute NCI
Organization: National Institutes of Health Clinical Center CC

Study Overview

Official Title: Genetic Susceptibility to Oncogenic Viruses
Status: COMPLETED
Status Verified Date: 2020-06
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: 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 Franciscos 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 NCIs Laboratory of Genomic Diversity
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 Franciscos 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 NCIs Laboratory of Genomic Diversity

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
OH98-C-N026 None None None