Official Title
A Multi-Center International Hospital-Based Case-Control Study of Lymphoma in Asia (AsiaLymph)
Brief Title
Study of Lymphoma in Asia
Protocol ID
NCT01584141
Lead Sponsor
National Cancer Institute (NCI)
Brief Summary
Background:
- Lymphoma rates in Asia have been lower than in the West, but rates have been rising in
recent years. Most studies of lymphoma patients have been conducted in the West. Less
information is available about the factors that might contribute to the rise of lymphoma
in Asia. Researchers want to collect medical and personal histories and samples from
people who have recently been diagnosed with lymphoma. This information will help them
study possible reasons for this increase.
Objectives:
- To collect samples and histories as part of an introductory study of lymphoma in Asia.
Eligibility:
- People between 18 and 79 years of age who have entered study hospitals in Hong Kong,
Taiwan, and mainland China for treatment for any type of lymphoma.
- Healthy volunteers between 18 and 79 who have never had lymphoma.
Design:
- Participants will be screened with a physical exam and medical history.
- They will provide blood samples and cheek cell samples for testing.
- Participants will complete a questionnaire about their personal health history. They
will answer questions about exposures to chemicals like pesticides. They will also
be asked about family medical history and work and residential history. Finally they
will answer questions about lifestyle factors like diet and exercise.
- They will give permission for the researchers to see their medical records.
Researchers will also have access to any tumor samples collected as part of
treatment.
Detailed Description
The contribution of environmental, occupational and genetic factors to lymphoma has
generated a series of novel findings in studies of Caucasians. However, none of the
chemical associations have been conclusively established and the identification of the
key, functional alleles in gene regions associated with risk of NHL requires further
elucidation. Further, the ability to follow-up, confirm, and extend these observations is
limited by the low prevalence and limited range of several important chemical exposures
and the high to complete linkage disequilibrium among key candidate genetic loci in
Western populations. To optimize the ability to build on and clarify these findings, it
is necessary to investigate populations that differ from Caucasians in both exposure
patterns and underlying genetic structure. A multidisciplinary case-control study of
lymphoma in Asia provides an opportunity to replicate and extend recent and novel
observations made in studies among Caucasians in a population that is distinctly
different with regard to patterns of key risk factors, including range of exposures,
prevalence of exposures, correlations between exposures, and variation in gene regions of
particular interest. Thus, a hospital-based case-control study of lymphoma in Eastern
Asia (i.e., AsiaLymph) of 4,200 cases and 4,200 controls to be enrolled over a three-year
period will be conducted. In addition, 2,000 cases of myeloid leukemias and an additional
2,400 cases with less common lymphoma subtypes will be enrolled as well. The major
postulated risk factors for evaluation in this study are chemical exposures (i.e.,
organochlorines, trichloroethylene, and benzene) and genetic susceptibility. Other
factors potentially related to NHL, such as viral infections, UV exposure, medical
conditions, and other lifestyle factors will also be explored. A particularly noteworthy
aspect of AsiaLymph is central pathology review with immunophenotyping by two of the
world s leading lymphoma pathologists, which will enable accurate analysis of findings by
molecular and histologic subtypes. AsiaLymph represents the optimal next step in the DCEG
lymphoma portfolio. AsiaLymph should confirm and extend previous findings, and yield
novel insights into the causes of lymphoma and leukemia in both Asia and the West.
Study Period
-
Enrollment Count
13,433 participants
Eligibility Criteria
- INCLUSION CRITERIA:
Eligible cases will be patients at a participating hospital who are between 18 and 79
years of age at time of initial diagnosis and admitted or treated with incident diagnoses
of any lymphoid or myeloid neoplasm including all NHL and Hodgkin disease. Although it is
important to understand the etiology of lymphoma in children as well, this undertaking
would require additional hospitals, instruments, expertise, and funding that are not
currently available to our research team. Adults over the age of 80 are generally among
the sickest patients in the hospital and often have multiple comorbidities, which may
preclude their participation in an interview of this length. Cases will be permanent
residents of the general geographic region that is served by the hospital at the time of
diagnosis. Cases will include chronic lymphocytic leukemia/small lymphocytic lymphoma,
Waldenstrom macroglobulinemia, plasmacytoma, multiple myeloma, aggressive NK cell
leukemia, cutaneous lymphomas, myeloid neoplasms, and immunosuppression-associated cases
(such as HIV, post transplant, Methotrexate use).
2,400 lymphoid neoplasm cases will be enrolled with less common subtypes in Asian
populations including Hodgkin disease, multiple myeloma, chronic lymphocytic leukemia,
and NK/T, T, follicular and marginal zone lymphoma, in order to increase statistical
power to study risk factors for these tumors.
EXCLUSION CRITERIA:
Cases with previous diagnosis of lymphoma, such as acute lymphoblastic lymphoma, multiple
myeloma, chronic lymphocytic leukemia, and non-Hodgkin lymphoma, are ineligible.
Filters
Lymphoma, Follicular
Lymphoma, Non-Hodgkin
Multiple Myleoma
Lympocytic, Follicular
Leukemia
Hodgkin Lymphoma
COMPLETED
ADULT
OLDER_ADULT