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ClinicalIndex Comparison Record
N/ACompleted· 228 target
Drug / intervention
Not specified
Likely dose
Not stated in record
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Search/NCT00339638
NCT00339638N/ACompleted

Prediagnostic Markers of Adult T-Cell Leukemia/Lymphoma Among Carriers of Human T-Lymphoma Virus Type I: A Collaborative Study

National Cancer Institute (NCI)·observational·Posted Jun 21, 2006·Updated Jul 2, 2017

In Brief

An observational study for Human T-Lymphoma Virus Type I. Completed, enrolled 228 participants across 5 sites in 3 countries.

Detailed 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 leukemia/lymphoma (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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesJamaica, Japan, United States
Collaborators--

Timeline

N/ACompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 21, 2006
Enrollment StartDec 21, 2004
Study CompletionMay 26, 2011
TodayJul 2, 2026
Posted 20.0 years ago