Ignite Creation Date:
2024-05-05 @ 4:52 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00339807
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2006-06-19
Brief Title:
Natural History of HTLV-I Infection Prospective Follow-up of a Cohort of Blood Donors in Jamaica
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Natural History of HTVL-I A Cross-Sectional Study of a Cohort of Blood Donors in Jamaica
Status:
COMPLETED
Status Verified Date:
2011-08-11
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:
Human T-lymphotrophic virus type I HTLV-I is endemic in southern Japan and the Caribbean but disease manifestations differ across geographic regions Though age gender and route of infection may determine the natural history of this infection the observed geographic differences also may in part reflect the distinct genetic background of the host as evidenced by the distribution of human leukocyte antigens HLA and the presence of other environmental factors
Studies already completed or ongoing have shown notable differences in incidence and prevalence of HTLV-I associated diseases and underscore the need for comparative studies and analyses in these areas This prospective new study of blood donors in Jamaica provides us with an opportunity to address many hypotheses regarding HTLV-I transmission and pathogenesis in the Caribbean in comparison with an ongoing cohort study of HTLV-I carriers in Japan
This study will
identify host factors associated with HTLV-I carrier status and HTLV-I pathogenesis
directly calculate the incidence of HTLV-I associated diseases in this population
examine the role of HTLV-I in the pathogenesis of other common infectious agents
Approximately 5000 blood donors who came to the National Blood Transfusion each year will be screened for HTLV-I serology Of those who agreed to participate all HTLV-I carriers and age- and sex-matched HTLV-I-negatives will be invited to the University of the West Indies clinic for a full study enrollment Study participants will be given a standardized questionnaire a full physical examination and a phlebotomy 25-30 mL and will be followed every other year for interim health status and additional phlebotomy All subjects will receive an ophthalmologic examination for detection of uveitis and other ocular diseases Some subjects will be further referred to a neurologist hematologist or dermatologist according to their signs and symptoms Approximately 1200 HTLV-I carriers and 600 HTLV-I negatives will be recruited for a longitudinal follow-up over the next 5-year period Two types of analyses will be conducted comparison of HTLV-I-positive and HTLV-I-negative subjects and comparison among HTLV carriers between those with a high level of viral load and those with a low level
Studies already completed or ongoing have shown notable differences in incidence and prevalence of HTLV-I associated diseases and underscore the need for comparative studies and analyses in these areas This prospective new study of blood donors in Jamaica provides us with an opportunity to address many hypotheses regarding HTLV-I transmission and pathogenesis in the Caribbean in comparison with an ongoing cohort study of HTLV-I carriers in Japan
This study will
identify host factors associated with HTLV-I carrier status and HTLV-I pathogenesis
directly calculate the incidence of HTLV-I associated diseases in this population
examine the role of HTLV-I in the pathogenesis of other common infectious agents
Approximately 5000 blood donors who came to the National Blood Transfusion each year will be screened for HTLV-I serology Of those who agreed to participate all HTLV-I carriers and age- and sex-matched HTLV-I-negatives will be invited to the University of the West Indies clinic for a full study enrollment Study participants will be given a standardized questionnaire a full physical examination and a phlebotomy 25-30 mL and will be followed every other year for interim health status and additional phlebotomy All subjects will receive an ophthalmologic examination for detection of uveitis and other ocular diseases Some subjects will be further referred to a neurologist hematologist or dermatologist according to their signs and symptoms Approximately 1200 HTLV-I carriers and 600 HTLV-I negatives will be recruited for a longitudinal follow-up over the next 5-year period Two types of analyses will be conducted comparison of HTLV-I-positive and HTLV-I-negative subjects and comparison among HTLV carriers between those with a high level of viral load and those with a low level
Detailed Description:
Southern Japan and the Caribbean are both endemic for human T-lymphotropic virus type I HTLV-I infection In these areas however epidemiology of HTLV-I appears to differ Various observations from population-based studies indicate that differences in host immune response to virus infection is likely to result in different frequencies of disease manifestations across geographic regions While gender age and route of infection may partly determine host immune response the observed geographic differences may also reflect in part host genetic background as evidenced by the distribution of human leukocyte antigens HLA and presence of other environmental factors
The reported differences underscore the need for comparative studies in these endemic areas In addition analyses of larger pooled data of HTLV-I carriers from different geographic areas are needed to ensure statistical power in studies of gene-environment interactions with extended use of molecular markers However existing population-based studies from Japan and the Caribbean are unfortunately no comparable with respect to the study subjects age and gender distributions In order to address this issue we proposed a study of blood donors in Jamaica which enrolls a large number of both HTLV-I positive and HTLV-I negative consisting of subjects that are more comparable to existing Japanese study with respect to age and sex The proposed study will provide a basis for a comparative study of HTLV-I carriers in Japan and Jamaica and a comprehensive analysis of host genetic background of HTLV-I associated illnesses in the Black population
The reported differences underscore the need for comparative studies in these endemic areas In addition analyses of larger pooled data of HTLV-I carriers from different geographic areas are needed to ensure statistical power in studies of gene-environment interactions with extended use of molecular markers However existing population-based studies from Japan and the Caribbean are unfortunately no comparable with respect to the study subjects age and gender distributions In order to address this issue we proposed a study of blood donors in Jamaica which enrolls a large number of both HTLV-I positive and HTLV-I negative consisting of subjects that are more comparable to existing Japanese study with respect to age and sex The proposed study will provide a basis for a comparative study of HTLV-I carriers in Japan and Jamaica and a comprehensive analysis of host genetic background of HTLV-I associated illnesses in the Black population
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-N112 | None | None | None |