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CompletedNCT00339937Updated Mar 22, 2024

Studies of Human Herpesvirus 8 and Kaposi's Sarcoma in Sicily

An observational study in Kaposi s Sarcoma (KS), sponsored by National Cancer Institute (NCI). Completed at 1 site in Italy. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2024-03-22.

Sponsored by National Cancer Institute (NCI) · Observational

Study type
Observational
Model
Case-control
Time perspective
Other
Enrollment
4,622
Ages
18 Years to 99 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Kaposi s Sarcoma (KS)

Keywords

  • Human Herpes virus 8 (HHV8)
  • Kaposi sarcoma (KS)
03

In context

Sarcoma, Kaposi

162 studies on the registry are indexed under Sarcoma, Kaposi; 29 are open to participants now.

This study's enrollment of 4,622 is above the median of 200 across 23 observational studies indexed under Sarcoma, Kaposi.

Browse Sarcoma, Kaposi studies →

Lead sponsor

National Cancer Institute (NCI) is the lead sponsor of 3,506 studies on the registry; 334 are open to participants now.

Of its 402 completed or terminated interventional studies of FDA-regulated products, 365 (91%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Population based samples of adults from Italy (Southern Italy).

Eligibility criteria

Pool of HHV8 seropositive controls.

05

Study design

Observational model
Case-control
Time perspective
Other
Enrollment
4,622 participants (actual)

Groups and cohorts

  • Cases

    Adults in Italy with Kaposi's sarcoma

  • Controls

    Adults in Italy without Kaposi's sarcoma

06

What researchers measure

Primary outcomes

  1. Kaposi Sarcoma (KS)

    Kaposi Sarcoma (KS)

    Time frame: 5 years

07

Study locations

1 site
  • Universita Degli Studi Di Palermo
    Palermo, Italy
08

References and documents

Publications

  • 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. PubMed 3491911 ↗
  • 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. PubMed 8624276 ↗
  • 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. PubMed 3336414 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 22, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00339937
Lead sponsor
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Jun 21, 2006
Start date
Jul 30, 1998
Primary completion
May 6, 2020
Completion
May 6, 2020
Last update
Mar 22, 2024

Study contacts

Sam M Mbulaiteye, M.D.
principal investigator · National Cancer Institute (NCI)
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.

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