Risk Factors for Non-HIV-Related Kaposi s Sarcoma

Kaposi's Sarcoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00339326
• Other study ID #: 999902282
• Secondary ID: 02-C-N282
• Status: Completed
• Start date: September 1, 2002
• Est. completion date: May 8, 2020

Study information

• Verified date: May 2020
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study will try to identify risk factors for Kaposi s sarcoma, a rare skin cancer, and to understand the role of the KSHV virus in development of the disease.

All native-born Italians 21 years of age or older residing in Sicily from July 1, 2002 through June 30, 2005 who have Kaposi s sarcoma not related to HIV infection may be eligible for this study. Healthy control subjects will also be enrolled.

All participants will be interviewed about their childhood, jobs, habits, medical conditions, and treatments. They also will provide a blood sample and a saliva sample, obtained by swishing a mouthwash for 45 seconds and spitting it into a container.

Blood will be tested for two viruses KSHV and HIV that are related to Kapsosi s sarcoma. The KSHV virus is newly discovered and not well understood. In general, a positive KSHV test probably means an infection with the virus has occurred in the past, but not necessarily that disease has developed. HIV is the virus that causes AIDS. People with AIDS have a high risk of Kapsosi s sarcoma. Although HIV and AIDS are very rare among older adults in Sicily, the presence of HIV must be ruled out in order to understand how KSHV is related to Kapsosi s sarcoma.

The blood may also be used to measure immunity (the body s defense against infection and cancer) and for genetic studies to help discover why Kapsosi s sarcoma occurs.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1383
• Est. completion date: May 8, 2020
• Est. primary completion date: May 8, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

• INCLUSION CRITERIA - CASES:

All non-AIDS, pathologically confirmed cases of KS (International Classification of Diseases for Oncology code M9140/3) in native born Italians resident in Sicily from 01 July 2002 through 30 June 2005 (3 years).

EXCLUSION CRITERIA - CASES:

AIDS, history of organ transplant, no pathologic confirmation, not born in Italy, not resident in Sicily, unable to provide informed consent, age less than 21.

INCLUSION CRITERIA - CONTROLS:

Native born Italians, resident in Sicily, on the GP's roster.

EXCLUSION CRITERIA - CONTROLS:

AIDS, history of KS, spouse or relative of an enrolled KS case or of another control, history of organ transplant, not born in Italy, not resident in Sicily, unable to provide informed consent, age less than 21.

Exclusion of children.

Related Conditions & MeSH terms

• Kaposi's Sarcoma
• Sarcoma
• Sarcoma, Kaposi

Locations

Country	Name	City	State
Italy	Universita Degli Studi Di Palermo	Palermo

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

Italy, 

References & Publications (3)

Cottoni F, Masala MV, Budroni M, Rosella M, Satta R, Locatelli F, Montesu MA, De Marco R. The role of occupation and a past history of malaria in the etiology of classic Kaposi's sarcoma: a case-control study in north-east Sardinia. Br J Cancer. 1997;76(11):1518-20. — View Citation

Touloumi G, Hatzakis A, Potouridou I, Milona I, Strarigos J, Katsambas A, Giraldo G, Beth-Giraldo E, Biggar RJ, Mueller N, Trichopoulos D. The role of immunosuppression and immune-activation in classic Kaposi's sarcoma. Int J Cancer. 1999 Sep 9;82(6):817-21. — View Citation

Ziegler JL, Newton R, Katongole-Mbidde E, Mbulataiye S, De Cock K, Wabinga H, Mugerwa J, Katabira E, Jaffe H, Parkin DM, Reeves G, Weiss R, Beral V. Risk factors for Kaposi's sarcoma in HIV-positive subjects in Uganda. AIDS. 1997 Nov;11(13):1619-26. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Kaposi sarcoma (KS)	Kaposi sarcoma	5 years