Status:
COMPLETED
Study of Adult T-Cell Leukemia/Lymphoma Among Carriers of HTLV-1
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Human T-Lymphoma Virus Type I
Eligibility:
All Genders
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 increas...
Detailed Description
To characterize molecular markers for risk of adult T-cell leukemia/lymphoma (ATL), whose incidence rate differs greatly across geographic areas, we propose to examine the prevalence and level of vira...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- CASES:
- Incident ATL cases will be identified from the various study cohorts. For Jamaica Family Study, in which prevalent cases were enrolled, we will only include cases that occurred among initially unaffected family members. The diagnosis of ATL follows universal criteria for all cohorts. For each case, one prediagnostic specimen will be analyzed. If there are more than one prediagnostic specimens, we will select the earliest drawdate from which both serum/plasma and DNA specimens are available. Whenever available, one postdiagnostic specimen will also be considered for analysis of longitudinal changes in marker levels.
- CONTROLS:
- Fro each index case, 2 age-, sex-, screen-matched asymptomatic HTLV-I carriers will be selected as controls, from within the same cohort in which the case arose (risk set sampling). For Jamaica Family Study, the control subjects are selected from unrelated subjects (such as spouses or incidental recruit unrelated to the index case) or from one or two population-based studies of unrelated subjects (i.e., food handlers study or mother-infant cohort study). For controls, specimens collected close to the time of pre- and post-diagnostic phlebotomy for the case will be analyzed.
Exclusion
Key Trial Info
Start Date :
December 21 2004
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 26 2011
Estimated Enrollment :
228 Patients enrolled
Trial Details
Trial ID
NCT00339638
Start Date
December 21 2004
End Date
May 26 2011
Last Update
July 2 2017
Active Locations (5)
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1
University of California, San Francisco
San Francisco, California, United States, 94143
2
Harvard School of Public Health
Boston, Massachusetts, United States
3
University of the West Indies
Kingston, Jamaica
4
Tokushima University
Tokushima, Japan