- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00341484
Genetic Susceptibility to Oncogenic Viruses
June 15, 2020 updated by: National Cancer Institute (NCI)
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Observational
Enrollment (Actual)
2580
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
San Francisco, California, United States, 94115
- University of California, San Francisco
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Residents of inner-city neighborhoods in San Francisco, CA.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Genetic determinants
Time Frame: 5 years
|
genetic determinants
|
5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Thomas R O'Brien, M.D., National Cancer Institute (NCI)
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Aka PV, Kuniholm MH, Pfeiffer RM, Wang AS, Tang W, Chen S, Astemborski J, Plankey M, Villacres MC, Peters MG, Desai S, Seaberg EC, Edlin BR, Strickler HD, Thomas DL, Prokunina-Olsson L, Sharp GB, O'Brien TR. Association of the IFNL4-DeltaG Allele With Impaired Spontaneous Clearance of Hepatitis C Virus. J Infect Dis. 2014 Feb 1;209(3):350-4. doi: 10.1093/infdis/jit433. Epub 2013 Aug 15.
- Prokunina-Olsson L, Muchmore B, Tang W, Pfeiffer RM, Park H, Dickensheets H, Hergott D, Porter-Gill P, Mumy A, Kohaar I, Chen S, Brand N, Tarway M, Liu L, Sheikh F, Astemborski J, Bonkovsky HL, Edlin BR, Howell CD, Morgan TR, Thomas DL, Rehermann B, Donnelly RP, O'Brien TR. A variant upstream of IFNL3 (IL28B) creating a new interferon gene IFNL4 is associated with impaired clearance of hepatitis C virus. Nat Genet. 2013 Feb;45(2):164-71. doi: 10.1038/ng.2521. Epub 2013 Jan 6.
- Uccellini L, Tseng FC, Monaco A, Shebl FM, Pfeiffer R, Dotrang M, Buckett D, Busch MP, Wang E, Edlin BR, Marincola FM, O'Brien TR. HCV RNA levels in a multiethnic cohort of injection drug users: human genetic, viral and demographic associations. Hepatology. 2012 Jul;56(1):86-94. doi: 10.1002/hep.25652. Epub 2012 Jun 1.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 1998
Primary Completion (Actual)
June 5, 2007
Study Completion (Actual)
June 5, 2007
Study Registration Dates
First Submitted
June 19, 2006
First Submitted That Met QC Criteria
June 19, 2006
First Posted (Estimate)
June 21, 2006
Study Record Updates
Last Update Posted (Actual)
June 16, 2020
Last Update Submitted That Met QC Criteria
June 15, 2020
Last Verified
June 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 999998026
- OH98-C-N026
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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