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

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Human T-Lymphoma Virus Type I

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Trial Information

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

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 viral and host immune response markers as well as the protein expression
pattern of 57 subjects who subsequently developed ATL and 171 matched control subjects who
participated in various prospective studies of carriers of human T-lymphotropic virus type I
(HTLV-I). Informative markers to be studied include provirus load, HTLV-I antibody titer,
anti-Tax protein, clonality of HTLV-I infected lymphocytes (viral markers), total
immunoglobulin E (IgE), C-reactive protein (CRP), neopterin, soluble CD30, soluble
interleukin-2 receptor (sIL2-R), EBV antibody profile (host immune markers), and proteomics.
These markers were selected based on the measurability on the majority of specimens,
availability of validated assays, relevance to the biology of T-cell malignancies, and has
been used in a cross-sectional comparison of HTLV-I carriers and non-carriers from Japan and
the Caribbean. We will utilize central laboratory and validated, standard assays for all
specimens. The results, unlinked to personal identifiers, will be analyzed using
generalized estimating equation. The findings will further our understanding of the
etiology of ATL, and of differences in natural history of HTLV-I infection across geographic

While pursuing the same theme of trying to identify host and viral markers associated with
ATL, the unique aspect of this proposal is to pool ATL cases, an extremely rare malignancy,
from multiple epidemiologic studies through international collaboration, in order to achieve
adequate statistical power and to perform valid comparison of tumor characteristics across
geographic areas.

Inclusion Criteria



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.


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.

Type of Study:


Study Design:



United States: Federal Government

Study ID:




Start Date:

December 2004

Completion Date:

May 2011

Related Keywords:

  • Human T-Lymphoma Virus Type I
  • Epidemiology
  • Risk Prediction
  • Biomarkers
  • Nested Case Control
  • Leukemia
  • Leukemia, T-Cell
  • Leukemia-Lymphoma, Adult T-Cell
  • Lymphoma



University of California, San Francisco San Francisco, California  94143
Harvard School of Public Health Boston, Massachusetts  02115