Seroprevalence of Kaposi's Sarcoma Herpes Virus in the United States
Primary Purpose
Kaposi's Sarcoma, Herpesviridae Infection
Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Kaposi's Sarcoma focused on measuring Human Herpesvirus B, NHANES, Epidemiology, Population-Based Study, Kaposi's Sarcoma Herpes Virus
Eligibility Criteria
No specific eligibility criteria was provided for this protocol.
Sites / Locations
- National Cancer Institute (NCI)
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00026728
First Posted
November 14, 2001
Last Updated
March 3, 2008
Sponsor
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00026728
Brief Title
Seroprevalence of Kaposi's Sarcoma Herpes Virus in the United States
Official Title
The Seroprevalence of Kaposi's Sarcoma Herpesvirus in the United States
Study Type
Observational
2. Study Status
Record Verification Date
December 2005
Overall Recruitment Status
Completed
Study Start Date
February 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Cancer Institute (NCI)
4. Oversight
5. Study Description
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:
Compare the prevalence of KSHV among different demographic groups in the United States
Examine the association between KSHV and high risk behaviors such as drug use (marijuana and cocaine), sexual behavior (age at first sexual intercourse and number of sexual partners), and medical risk factors (herpes simplex virus II, hepatitis B and hepatitis C)
Estimate the prevalence of KSHV in the United States.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kaposi's Sarcoma, Herpesviridae Infection
Keywords
Human Herpesvirus B, NHANES, Epidemiology, Population-Based Study, Kaposi's Sarcoma Herpes Virus
7. Study Design
Enrollment
20169 (false)
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
No specific eligibility criteria was provided for this protocol.
Facility Information:
Facility Name
National Cancer Institute (NCI)
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
7891487
Citation
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. doi: 10.1016/s0140-6736(95)90641-x.
Results Reference
background
Links:
URL
http://clinicalstudies.info.nih.gov/detail/B_2001-C-0073.html
Description
NIH Clinical Center Detailed Web Page
Learn more about this trial
Seroprevalence of Kaposi's Sarcoma Herpes Virus in the United States
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