Kaposi s Sarcoma (KS) Clinical Trial
Official title:
Studies of Human Herpesvirus 8 and Kaposi's Sarcoma in Sicily
| Verified date | May 2020 |
| Source | National Institutes of Health Clinical Center (CC) |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 4622 |
| Est. completion date | May 6, 2020 |
| Est. primary completion date | May 6, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 99 Years |
| Eligibility | Pool of HHV8 seropositive controls. |
| Country | Name | City | State |
|---|---|---|---|
| Italy | Universita Degli Studi Di Palermo | Palermo |
| Lead Sponsor | Collaborator |
|---|---|
| National Cancer Institute (NCI) |
Italy,
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. — View 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. — View 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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Kaposi Sarcoma (KS) | Kaposi Sarcoma (KS) | 5 years |