Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00339326
Status:
COMPLETED
Last Update Posted:
2021-03-12
First Post:
2006-06-19
Brief Title:
Risk Factors for Non-HIV-Related Kaposi s Sarcoma
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Cofactors for Classical Kaposis Sarcoma and for Kaposis Sarcoma-Associated Herpesvirus Infection A Case-Control Study in Sicily
Status:
COMPLETED
Status Verified Date:
2020-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 15- 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 02-C-N282 | None | None | None |