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

NCT ID: NCT00339937

Last Updated: 2024-03-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

4622 participants

Study Classification

OBSERVATIONAL

Study Start Date

1998-07-30

Study Completion Date

2020-05-06

Brief Summary

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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

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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.

Conditions

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Kaposi s Sarcoma (KS)

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

OTHER

Study Groups

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Cases

Adults in Italy with Kaposi's sarcoma

No interventions assigned to this group

Controls

Adults in Italy without Kaposi's sarcoma

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

Pool of HHV8 seropositive controls.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sam M Mbulaiteye, M.D.

Role: PRINCIPAL_INVESTIGATOR

National Cancer Institute (NCI)

Locations

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Universita Degli Studi Di Palermo

Palermo, , Italy

Site Status

Countries

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Italy

References

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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.

Reference Type BACKGROUND
PMID: 3491911 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8624276 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 3336414 (View on PubMed)

Other Identifiers

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OH98-C-N035

Identifier Type: -

Identifier Source: secondary_id

999998035

Identifier Type: -

Identifier Source: org_study_id

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