Risk Factors for Non-HIV-Related Kaposi s Sarcoma

March 11, 2021 updated by: National Cancer Institute (NCI)

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

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.

Study Overview

Status

Completed

Conditions

Kaposi's Sarcoma

Detailed 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.

Study Type

Observational

Enrollment (Actual)

1383

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Italy
- - Palermo, Italy
    - Universita degli Studi di Palermo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Case-Control
Time Perspectives: Other

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
Cases with Kaposi's Sarcoma Cases with Kaposi's Sarcoma from Southern Italy.
Controls without KS Controls from Southern Italy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Kaposi sarcoma (KS) Time Frame: 5 years	Kaposi sarcoma	5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Investigators

Principal Investigator: Sam M Mbulaiteye, M.D., National Cancer Institute (NCI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2002

Primary Completion (Actual)

May 8, 2020

Study Completion (Actual)

May 8, 2020

Study Registration Dates

First Submitted

June 19, 2006

First Submitted That Met QC Criteria