Study of Lymphoma in Asia

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01584141
First received: April 21, 2012
Last updated: July 22, 2014
Last verified: July 2014
  Purpose

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.

Condition
Lymphoma, Non-Hodgkin
Multiple Myleoma
Lympocytic, Follicular
Leukemia
Hodgkin Lymphoma

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: A Multi-Center International Hospital-Based Case-Control Study of Lymphoma in Asia (AsiaLymph)

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Evaluation of chemical exposures and genetic susceptibility [ Time Frame: 2020 ]
  • Explore relationship between other factors (viral infections, UV exposure, medical conditions, and lifestyle factors and non-Hodgkin Lymphoma [ Time Frame: 2020 ]

Estimated Enrollment: 10400
Study Start Date: July 2011
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 3,300 cases and 3,300 controls to be enrolled over a three-year period will be conducted. 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 in both Asia and the West.

  Eligibility

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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, Waldenstr(SqrRoot)(Delta)m macroglobulinemia, plasmacytoma, multiple myeloma, aggressive NK cell leukemia, cutaneous lymphomas, and immunosuppression-associated cases (such as HIV, post transplant, Methotrexate use).

EXCLUSION CRITERIA:

Cases with previous diagnosis of lymphoma, such as acute lymphoblastic lymphoma, multiple myeloma, chronic lymphocytic leukemia, and non-Hodgkin lymphoma, are ineligible.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01584141

Contacts
Contact: Qing Lan, M.D. (301) 496-9093 qingl@mail.nih.gov

Locations
China
Tianjin Medical University Cancer Institute & Hospital Recruiting
Hexi District, China, 300060
Hong Kong
University of Hong Kong Recruiting
Pokfulam, Hong Kong
Taiwan
Buddhis Dalin Tzu Chi Genernal Hospital Recruiting
Dalin Town, Taiwan
Sponsors and Collaborators
Investigators
Principal Investigator: Qing Lan, M.D. National Cancer Institute (NCI)
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT01584141     History of Changes
Other Study ID Numbers: 999911206, 11-C-N206
Study First Received: April 21, 2012
Last Updated: July 22, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Leukemia
Lymphoma
Occupational Epidemiology
Molecular Epidemiology
Genetic Polymorphisms

Additional relevant MeSH terms:
Hodgkin Disease
Leukemia
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on July 28, 2014