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| Tracking Information | |
|---|---|
| First Received Date ICMJE | November 14, 2001 |
| Last Updated Date | March 3, 2008 |
| Start Date ICMJE | February 2001 |
| Primary Completion Date | |
| Current Primary Outcome Measures ICMJE | |
| Original Primary Outcome Measures ICMJE | |
| Change History | Complete list of historical versions of study NCT00026728 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | |
| Original Secondary Outcome Measures ICMJE | |
| Descriptive Information | |
| Brief Title ICMJE | Seroprevalence of Kaposi's Sarcoma Herpes Virus in the United States |
| Official Title ICMJE | The Seroprevalence of Kaposi's Sarcoma Herpesvirus in the United States |
| Brief Summary | This study will investigate patterns of Kaposi's sarcoma herpes virus (KSHV) in the United States and its potential impact on the U.S. population. KSHV is a newly discovered virus that is strongly associated with Kaposi's sarcoma and primary effusion lymphoma. The high prevalence of KS and KSHV among HIV-infected homosexual men suggests sexual contact as a primary mode of transmission. Reports of non-sexual transmission in parts of Africa and the Mediterranean where Kaposi's sarcoma is endemic, and the identification of viral DNA in saliva and other bodily fluids, however, indicate the virus is also transmitted non-sexually. This study will:
Data and blood samples for the study will be taken from the NHANES III survey. NHANES is a program of periodic surveys conducted by the Centers for Disease Control and Prevention's National Center for Health Statistics. The survey is designed to provide national estimates of health status for the United States non-institutionalized civilian population by means of household interviews, standardized physical examinations, and blood sample collection and testing. NHANES III-the seventh in a series of national examination studies-was conducted from 1988 to 1994. This study will use the HANES data to identify risks associated with a KSHV-positive blood test in the survey population. The study plans to include all 19,754 participants (67% of the 29,314 participants originally examined) for whom blood samples were collected and remain available. |
| Detailed Description | Kaposi sarcoma herpesvirus (KSHV) is the viral cause of Kaposi sarcoma. Although infection with this virus appears to be uncommon in the United States, the prevalence in the general population in uncertain, and routes for transmission are poorly characterized. This study makes use of questionnaire data and serum specimens obtained in the third National Health and Nutrition Survey (NHAnes III). Sera from 18,168 individuals in this study were tested for antibodies to the KSHV proteins K8.1 and LANA. We will use these measurements to estimate KSHV seroprevalence for the overall U.S. general population and for demographic subgroups. To characterize potential transmission routes, we will also examine whether KSHV seroprevalence is related to sexual activity and exposures to blood, as indicated by responses to questionnaire items and previous NHANES III measurements of markers of relevant viral infections. |
| Study Phase | |
| Study Type ICMJE | Observational |
| Study Design ICMJE | |
| Condition ICMJE |
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| Intervention ICMJE | |
| Study Arms / Comparison Groups | |
| Publications * | Huang YQ, Li JJ, Kaplan MH, Poiesz B, Katabira E, Zhang WC, Feiner D, Friedman-Kien AE. Human herpesvirus-like nucleic acid in various forms of Kaposi's sarcoma. Lancet. 1995 Mar 25;345(8952):759-61. |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | 20169 |
| Completion Date | December 2005 |
| Primary Completion Date | |
| Eligibility Criteria ICMJE | -No specific eligibility criteria was provided for this protocol. |
| Gender | Both |
| Ages | |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States |
| Administrative Information | |
| NCT ID ICMJE | NCT00026728 |
| Responsible Party | |
| Study ID Numbers ICMJE | 010073, 01-C-0073 |
| Study Sponsor ICMJE | National Cancer Institute (NCI) |
| Collaborators ICMJE | |
| Investigators ICMJE | |
| Information Provided By | National Institutes of Health Clinical Center (CC) |
| Verification Date | December 2005 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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