Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00339638
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2006-06-19
Brief Title:
Study of Adult T-Cell LeukemiaLymphoma Among Carriers of HTLV-1
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Prediagnostic Markers of Adult T-Cell LeukemiaLymphoma Among Carriers of Human T-Lymphoma Virus Type I A Collaborative Study
Status:
COMPLETED
Status Verified Date:
2011-05-26
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 identify chemical and protein markers in the blood of people who carry the human T-lymphotropic virus type I HTLV-I a virus associated with various pathologies including an increased risk in adults of a rare and aggressive cancer called adult T cell leukemialymphoma ATL The study will also examine differences in these markers before and after the onset of ATL
ATL has been reported in every area where HTLV-1 is common including the Caribbean and parts of Japan West Africa the Middle East South America and Pacific Melanesia Risk factors for the disease are largely unknown and seem to vary among those affected in different endemic regions People who acquire the infection early in life are thought to be at higher risk than those who are infected later In Japan men seem to be at greater risk than women but the same is not evident among the black population in the Caribbean and Brazil
Findings from this study will increase understanding of the cause of ATL and identify differences in tumor characteristics and the course of disease across geographical areas
Study subjects are drawn from among participants in eight studies of HTLV-1 carriers including the 1 Jamaica Mother-Infant Cohort Study 2 Jamaica Family Study 3 Jamaica Food Handlers Study 4 Miyazaki Cohort Study in Japan 5 Nagasaki Cohort Study in Japan 6 Japan Public Health Center-based Prospective Study on Cancer and Cardiovascular Disease 7 HTLV Outcome Studies in the United States and 8 GIPH Cohort Study in Brazil
Stored blood samples previously collected from patients in the above studies who did and did not develop ATL will be analyzed for immunologic and genetic factors
ATL has been reported in every area where HTLV-1 is common including the Caribbean and parts of Japan West Africa the Middle East South America and Pacific Melanesia Risk factors for the disease are largely unknown and seem to vary among those affected in different endemic regions People who acquire the infection early in life are thought to be at higher risk than those who are infected later In Japan men seem to be at greater risk than women but the same is not evident among the black population in the Caribbean and Brazil
Findings from this study will increase understanding of the cause of ATL and identify differences in tumor characteristics and the course of disease across geographical areas
Study subjects are drawn from among participants in eight studies of HTLV-1 carriers including the 1 Jamaica Mother-Infant Cohort Study 2 Jamaica Family Study 3 Jamaica Food Handlers Study 4 Miyazaki Cohort Study in Japan 5 Nagasaki Cohort Study in Japan 6 Japan Public Health Center-based Prospective Study on Cancer and Cardiovascular Disease 7 HTLV Outcome Studies in the United States and 8 GIPH Cohort Study in Brazil
Stored blood samples previously collected from patients in the above studies who did and did not develop ATL will be analyzed for immunologic and genetic factors
Detailed Description:
To characterize molecular markers for risk of adult T-cell leukemialymphoma ATL whose incidence rate differs greatly across geographic areas we propose to examine the prevalence and level of viral and host immune response markers as well as the protein expression pattern of 57 subjects who subsequently developed ATL and 171 matched control subjects who participated in various prospective studies of carriers of human T-lymphotropic virus type I HTLV-I Informative markers to be studied include provirus load HTLV-I antibody titer anti-Tax protein clonality of HTLV-I infected lymphocytes viral markers total immunoglobulin E IgE C-reactive protein CRP neopterin soluble CD30 soluble interleukin-2 receptor sIL2-R EBV antibody profile host immune markers and proteomics These markers were selected based on the measurability on the majority of specimens availability of validated assays relevance to the biology of T-cell malignancies and has been used in a cross-sectional comparison of HTLV-I carriers and non-carriers from Japan and the Caribbean We will utilize central laboratory and validated standard assays for all specimens The results unlinked to personal identifiers will be analyzed using generalized estimating equation The findings will further our understanding of the etiology of ATL and of differences in natural history of HTLV-I infection across geographic areas
While pursuing the same theme of trying to identify host and viral markers associated with ATL the unique aspect of this proposal is to pool ATL cases an extremely rare malignancy from multiple epidemiologic studies through international collaboration in order to achieve adequate statistical power and to perform valid comparison of tumor characteristics across geographic areas
While pursuing the same theme of trying to identify host and viral markers associated with ATL the unique aspect of this proposal is to pool ATL cases an extremely rare malignancy from multiple epidemiologic studies through international collaboration in order to achieve adequate statistical power and to perform valid comparison of tumor characteristics across geographic areas
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 |
|---|---|---|---|
| 05-C-N068 | None | None | None |