NCT00026728

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20,169

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2001

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2001

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 14, 2001

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 15, 2001

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
Last Updated

March 4, 2008

Status Verified

December 1, 2005

First QC Date

November 14, 2001

Last Update Submit

March 3, 2008

Conditions

Keywords

Human Herpesvirus BNHANESEpidemiologyPopulation-Based StudyKaposi's Sarcoma Herpes Virus

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
* No specific eligibility criteria was provided for this protocol.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

National Cancer Institute (NCI)

Bethesda, Maryland, 20892, United States

Location

Related Publications (1)

  • 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.

    PMID: 7891487BACKGROUND

Related Links

MeSH Terms

Conditions

Sarcoma, KaposiHerpesviridae Infections

Condition Hierarchy (Ancestors)

DNA Virus InfectionsVirus DiseasesInfectionsSarcomaNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsNeoplasms, Vascular Tissue

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

November 14, 2001

First Posted

November 15, 2001

Study Start

February 1, 2001

Study Completion

December 1, 2005

Last Updated

March 4, 2008

Record last verified: 2005-12

Locations