NCT00339326

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,383

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2002

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2002

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

June 19, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 21, 2006

Completed
13.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 8, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 8, 2020

Completed
Last Updated

March 12, 2021

Status Verified

May 1, 2020

Enrollment Period

17.7 years

First QC Date

June 19, 2006

Last Update Submit

March 11, 2021

Conditions

Kaposi's Sarcoma

Keywords

Human Herpes virus 8 (HHV8)Kaposis sarcoma (KS)Kaposi SarcomaKarposi Sarcoma-Associated HerpesvirusKSHVKS

Outcome Measures

Primary Outcomes (1)

  • Kaposi sarcoma (KS)

    Kaposi sarcoma

    5 years

Study Arms (2)

Cases with Kaposi's Sarcoma

Cases with Kaposi's Sarcoma from Southern Italy.

Controls without KS

Controls from Southern Italy.

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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).

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universita Degli Studi Di Palermo

Palermo, Italy

Location

Related 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. doi: 10.1038/bjc.1997.587.

    PMID: 9400951BACKGROUND

  • 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. doi: 10.1002/(sici)1097-0215(19990909)82:63.0.co;2-7.

    PMID: 10446447BACKGROUND

  • 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. doi: 10.1097/00002030-199713000-00011.

    PMID: 9365767BACKGROUND

MeSH Terms

Conditions

Sarcoma, Kaposi

Condition Hierarchy (Ancestors)

Herpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsSarcomaNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsNeoplasms, Vascular Tissue

Study Officials

  • Sam M Mbulaiteye, M.D.

    National Cancer Institute (NCI)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2006

First Posted

June 21, 2006

Study Start

September 1, 2002

Primary Completion

May 8, 2020

Study Completion

May 8, 2020

Last Updated

March 12, 2021

Record last verified: 2020-05

Locations

IT(1)