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| Sponsor: | National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Institutes of Health Clinical Center (CC) |
| ClinicalTrials.gov Identifier: | NCT00340821 |
Purpose
Doctors of the University of West Indies, the Caribbean Epidemiology Center (CAREC) and the National Cancer Institute have been studying the epidemiology of HTLV-I and its role in the etiology and pathogenesis of adult T-cell leukemia/lymphoma (ALT), and aggressive T-cell lymphoma. The purpose of the current study is to evaluate familial and genetic aspects of ATL and its relationship to two other HTLV-I related conditions, HTLV-I associated myelopathy also known as tropical spastic paraparesis (HAM/TSP), and infective dermatitis. Enrollment of infective dermatitis cases was recently added and the disease entity is thought to be a harbinger for later development of either ATL or HAM/TSP. The purpose of this study is to interview patients with these conditions and perform laboratory studies (specifically, HLA and other viral or genetic studies) to better understand these diseases and their relationship to the HTLV-1 virus and the family history and genetic factors that may be involved as well.
| Condition |
|---|
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HTLV-I |
| Study Type: | Observational |
| Official Title: | A Study of Familial and Genetic Aspects of Adult T-Cell Leukemia/Lymphoma, Tropical Spastic Paraparesis and Infective Dermatitis in Jamaica |
| Estimated Enrollment: | 1800 |
| Study Start Date: | May 1993 |
| Primary Completion Date: | July 2007 (Final data collection date for primary outcome measure) |
Doctors of the University of West Indies, the Caribbean Epidemiology Center (CAREC) and the National Cancer Institute have been studying the epidemiology of HTLV-I and its role in the etiology and pathogenesis of adult T-cell leukemia/lymphoma (ALT), and aggressive T-cell lymphoma. The purpose of the current study is to evaluate familial and genetic aspects of ATL and its relationship to two other HTLV-I related conditions, HTLV-I associated myelopathy also known as tropical spastic paraparesis (HAM/TSP), and infective dermatitis. Enrollment of infective dermatitis cases was recently added and the disease entity is thought to be a harbinger for later development of either ATL or HAM/TSP. The purpose of this study is to interview patients with these conditions and perform laboratory studies (specifically, HLA and other viral or genetic studies) to better understand these diseases and their relationship to the HTLV-1 virus and the family history and genetic factors that may be involved as well.
Eligibility| Ages Eligible for Study: | 2 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
All cases of ATL and TSP which satisfy the case definitions above. Cases will be selected regardless of HTLV-1 sero-status.
EXCLUSION CRITERIA:
Cases who have none of the first three priority family members available i.e. parents, offspring and siblings, will be excluded from this study however summary data will be maintained.
Contacts and Locations
More Information
| Study ID Numbers: | 999996018, OH96-C-N018 |
| Study First Received: | June 19, 2006 |
| Last Updated: | August 24, 2009 |
| ClinicalTrials.gov Identifier: | NCT00340821 History of Changes |
| Health Authority: | United States: Federal Government |
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HTLV-I |
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Leukemia, Lymphoid Spinal Cord Diseases Paraparesis, Tropical Spastic Central Nervous System Viral Diseases Paraparesis, Spastic Signs and Symptoms Leukemia Retroviridae Infections Dermatitis RNA Virus Infections Paresis Neoplasms by Histologic Type Immunoproliferative Disorders Skin Diseases Immune System Diseases |
Leukemia-Lymphoma, Adult T-Cell Nervous System Diseases Central Nervous System Diseases Virus Diseases Lymphatic Diseases Neoplasms Central Nervous System Infections Leukemia, T-Cell Neurologic Manifestations Myelitis HTLV-I Infections Deltaretrovirus Infections Lymphoproliferative Disorders Paraparesis |