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Study of Adult T-Cell Leukemia/Lymphoma Among Carriers of HTLV-1

NCT00339638 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 228

Last updated 2017-07-02

No results posted yet for this study

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.

Conditions

  • Human T-Lymphoma Virus Type I

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-12-21
Completion
2011-05-26

Countries

  • United States
  • Jamaica
  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00339638 on ClinicalTrials.gov