Trial Information

Cofactors for Classical Kaposi's Sarcoma and for Kaposi's Sarcoma-Associated Herpesvirus Infection: A Case-Control Study in Sicily

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.