Risk Factors for Non-HIV-Related Kaposi s Sarcoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00339326
Recruitment Status : Completed
First Posted : June 21, 2006
Last Update Posted : April 5, 2018
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

Brief Summary:

This study will try to identify risk factors for Kaposi s sarcoma, a rare skin cancer, and to understand the role of the KSHV virus in development of the disease.

All native-born Italians 21 years of age or older residing in Sicily from July 1, 2002 through June 30, 2005 who have Kaposi s sarcoma not related to HIV infection may be eligible for this study. Healthy control subjects will also be enrolled.

All participants will be interviewed about their childhood, jobs, habits, medical conditions, and treatments. They also will provide a blood sample and a saliva sample, obtained by swishing a mouthwash for 45 seconds and spitting it into a container.

Blood will be tested for two viruses KSHV and HIV that are related to Kapsosi s sarcoma. The KSHV virus is newly discovered and not well understood. In general, a positive KSHV test probably means an infection with the virus has occurred in the past, but not necessarily that disease has developed. HIV is the virus that causes AIDS. People with AIDS have a high risk of Kapsosi s sarcoma. Although HIV and AIDS are very rare among older adults in Sicily, the presence of HIV must be ruled out in order to understand how KSHV is related to Kapsosi s sarcoma.

The blood may also be used to measure immunity (the body s defense against infection and cancer) and for genetic studies to help discover why Kapsosi s sarcoma occurs.

Condition or disease
Kaposi's Sarcoma

Detailed Description:
Persons infected with the Kaposi s sarcoma-associated herpesvirus (KSHV) are at risk for developing Kaposi s sarcoma (KS), but the risk factors for KSHV infection and for KS following infection are not well defined. Classical KS (cKS) occurs without apparent immune deficiency (such as AIDS or an allograft). The proposed study will test specific hypotheses and generate new hypotheses on the risk of cKS among persons who have antibodies against KSHV, on the risk of KSHV seropositivity, and on the risk of active KSHV infection, defined as KSHV viremia or viral shedding in saliva. To do so, 120 incident cases of cKS from throughout Sicily and approximately 1800 persons (15% KSHV seropositive) of similar age, sex, and community size will be asked to participate by providing questionnaire data and blood and saliva specimens. Residual formalin-fixed, paraffin embedded tissue from KS skin biopsies will be available for verification of diagnosis and molecular analyses. Primary hypotheses are focused on host genetic susceptibility, endogenous clinical conditions (such as asthma and allergy), and exogenous exposures (cigarette smoking and contact with certain plants, water and soil) that are postulated to affect KSHV activation, dissemination, and disease induction. The study will have sufficient statistical power to detect factors that increase the risk of KSHV seropositivity by 1.5- to 2-fold, the risk of cKS by 2- to 3-fold, and the risk of KSHV viremia or shedding by 3- to 4-fold.

Study Type : Observational
Actual Enrollment : 1383 participants
Observational Model: Case-Control
Time Perspective: Other
Official Title: Cofactors for Classical Kaposi's Sarcoma and for Kaposi's Sarcoma-Associated Herpesvirus Infection: A Case-Control Study in Sicily
Study Start Date : September 1, 2002

Primary Outcome Measures :
  1. Kaposi sarcoma (KS) [ Time Frame: 5 years ]

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Ages Eligible for Study:   up to 99 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

All non-AIDS, pathologically confirmed cases of KS (International Classification of Diseases for Oncology code M9140/3) in native born Italians resident in Sicily from 01 July 2002 through 30 June 2005 (3 years).


AIDS, history of organ transplant, no pathologic confirmation, not born in Italy, not resident in Sicily, unable to provide informed consent, age less than 21.


Native born Italians, resident in Sicily, on the GP's roster.


AIDS, history of KS, spouse or relative of an enrolled KS case or of another control, history of organ transplant, not born in Italy, not resident in Sicily, unable to provide informed consent, age less than 21.

Exclusion of children.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00339326

Universita Degli Studi Di Palermo
Palermo, Italy
Sponsors and Collaborators
National Cancer Institute (NCI)
Principal Investigator: Sam M Mbulaiteye, M.D. National Cancer Institute (NCI)

Responsible Party: National Cancer Institute (NCI) Identifier: NCT00339326     History of Changes
Other Study ID Numbers: 999902282
First Posted: June 21, 2006    Key Record Dates
Last Update Posted: April 5, 2018
Last Verified: January 23, 2018

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):
Human Herpes virus 8 (HHV8)
Kaposis sarcoma (KS)
Kaposi Sarcoma
Karposi Sarcoma-Associated Herpesvirus

Additional relevant MeSH terms:
Sarcoma, Kaposi
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Neoplasms, Vascular Tissue