Clinical trial NCT00339937: Studies of Human Herpesvirus 8 and Kaposi's Sarcoma in Sicily
Official title: Studies of Human Herpesvirus 8 and Kaposi's Sarcoma in Sicily
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kaposi s Sarcoma (KS)
Keywords: Human Herpes virus 8 (HHV8)
Kaposi sarcoma (KS)
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2006-06-21
Enrollment: 4622
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Population based samples of adults from Italy (Southern Italy).

Brief summary: A series of studies will be conducted in Sicily by a collaborative team from the U.S. National Cancer Institute and the University of Palermo to better understand the prevalence and risk factors for the newly discovered human herpes virus 8 (HHV8) and Kaposi s sarcoma (KS), which may be a consequence of HHV8 infection. There are four short-term projects:

1. To determine HHV8 seroprevalence in extant, unlinked sera from informative groups, including homosexual men, persons with sexually transmitted diseases, and in general population groups, particularly the elderly. In addition, HHV8 prevalence and other serological studies may be determined among other adults, particularly those who may be recruited for future studies and those likely to enhance understanding of HHV8 serology.
2. To identify a pediatric syndrome that might be associated with HHV8 infection, HHV8 seroprevalence will be determined in sera from hospitalized children with a wide range of clinical conditions.
3. To determine HHV8 seroprevalence in various regions of Italy and by HLA Class II groups that have been linked to increased (HLA-DR5) or decreased (HLA-DR3) risk of KS, using extant, unlinked sera and data from volunteer bone marrow donors.
4. To conduct a case control study that will identify risk factors for KS among persons who are infected with HHV8 and who manifest anti-HHV8 latent antibodies.

The results of these projects will be summarized for publication in the medical and scientific literature and for the design and prioritization of related projects in the future.

Detailed description: A series of studies will be conducted in Sicily by a collaborative team from the U.S. National Cancer Institute and the University of Palermo to better understand the prevalence and risk factors for the newly discovered human herpes virus 8 (HHV8) and Kaposi s sarcoma (KS), which may be a consequence of HHV8 infection. There are four short-term projects:

1. To determine HHV8 seroprevalence in extant, unlinked sera from informative groups, including homosexual men, persons with sexually transmitted diseases, and in general population groups, particularly the elderly. In addition, HHV8 prevalence and other serological studies may be determined among other adults, particularly those who may be recruited for future studies and those likely to enhance understanding of HHV8 serology.
2. To identify a pediatric syndrome that might be associated with HHV8 infection, HHV8 seroprevalence will be determined in sera from hospitalized children with a wide range of clinical conditions.
3. To determine HHV8 seroprevalence in various regions of Italy and by HLA Class II groups that have been linked to increased (HLA-DR5) or decreased (HLA-DR3) risk of KS, using extant, unlinked sera and data from volunteer bone marrow donors.
4. To conduct a case control study that will identify risk factors for KS among persons who are infected with HHV8 and who manifest anti-HHV8 latent antibodies.

The results of these projects will be summarized for publication in the medical and scientific literature and for the design and prioritization of related projects in the future.

Eligibility criteria: Pool of HHV8 seropositive controls.

Primary outcomes:
measure: Kaposi Sarcoma (KS)
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Palermo
country: Italy
facility: Universita Degli Studi Di Palermo
Study officials:
affiliation: National Cancer Institute (NCI)
name: Sam M Mbulaiteye, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Goedert JJ, Biggar RJ, Melbye M, Mann DL, Wilson S, Gail MH, Grossman RJ, DiGioia RA, Sanchez WC, Weiss SH, et al. Effect of T4 count and cofactors on the incidence of AIDS in homosexual men infected with human immunodeficiency virus. JAMA. 1987 Jan 16;257(3):331-4.
citation: Cottoni F, De Marco R, Montesu MA. Classical Kaposi's sarcoma in north-east Sardinia: an overview from 1977 to 1991. Br J Cancer. 1996 May;73(9):1132-3. doi: 10.1038/bjc.1996.217.
citation: Biggar RJ, Nasca PC, Burnett WS. AIDS-related Kaposi's sarcoma in New York City in 1977. N Engl J Med. 1988 Jan 28;318(4):252. No abstract available.