Human T-Lymphoma Virus Type I Clinical Trial
Official title:
Prediagnostic Markers of Adult T-Cell Leukemia/Lymphoma Among Carriers of Human T-Lymphoma Virus Type I: A Collaborative Study
| Verified date | May 26, 2011 |
| Source | National Institutes of Health Clinical Center (CC) |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 228 |
| Est. completion date | May 26, 2011 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility |
- 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. |
| Country | Name | City | State |
|---|---|---|---|
| Jamaica | University of the West Indies | Kingston | |
| Japan | Tokushima University | Tokushima City | |
| Japan | National Cancer Center Research Institute | Toyko | |
| United States | Harvard School of Public Health | Boston | Massachusetts |
| United States | University of California, San Francisco | San Francisco | California |
| Lead Sponsor | Collaborator |
|---|---|
| National Cancer Institute (NCI) |
United States, Jamaica, Japan,
Manns A, Hisada M, La Grenade L. Human T-lymphotropic virus type I infection. Lancet. 1999 Jun 5;353(9168):1951-8. Review. — View Citation
Uchiyama T, Yodoi J, Sagawa K, Takatsuki K, Uchino H. Adult T-cell leukemia: clinical and hematologic features of 16 cases. Blood. 1977 Sep;50(3):481-92. — View Citation
Yamaguchi K, Seiki M, Yoshida M, Nishimura H, Kawano F, Takatsuki K. The detection of human T cell leukemia virus proviral DNA and its application for classification and diagnosis of T cell malignancy. Blood. 1984 May;63(5):1235-40. — View Citation