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NCT00341484
Genetic Susceptibility to Oncogenic Viruses
trial in Liver Neoplasms in 2,580 participants. Completed in 5 June 2007.
5 June 2007
Quick facts
| Lead sponsor | National Cancer Institute (NCI) |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 2,580 |
| Start date | 1 June 1998 |
| Primary completion | 5 June 2007 |
| Estimated completion | 5 June 2007 |
| Sites | 1 location across United States |
Conditions studied
- Liver Neoplasms — all drugs for Liver Neoplasms →
- HIV Infections — all drugs for HIV Infections →
Sponsor
National Cancer Institute (NCI)
Who can join
Adults 18 to 100, any sex, with Liver Neoplasms or HIV Infections. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own 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 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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT00341484
- Europe PMC full search
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00341484 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by National Cancer Institute (NCI)
- Last refreshed: 16 June 2020
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