Clinical trial · Observational
Risk Factors for Non-HIV-Related Kaposi s Sarcoma
Cofactors for Classical Kaposi's Sarcoma and for Kaposi's Sarcoma-Associated Herpesvirus Infection: A Case-Control Study in Sicily
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Kaposi's Sarcoma | Kaposi Sarcoma | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Cases with Kaposi's Sarcoma
- description
- Cases with Kaposi's Sarcoma from Southern Italy.
- label
- Controls without KS
- description
- Controls from Southern Italy.
Primary outcomes (1)
- measure
- Kaposi sarcoma (KS)
- timeFrame
- 5 years
- description
- Kaposi sarcoma
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
* 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.
References
Publications (3)
- BACKGROUNDCottoni 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. doi: 10.1038/bjc.1997.587. PMID 9400951
- BACKGROUNDTouloumi 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. doi: 10.1002/(sici)1097-0215(19990909)82:63.0.co;2-7. PMID 10446447
- BACKGROUNDZiegler 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. doi: 10.1097/00002030-199713000-00011. PMID 9365767