Study of Lymphoma in Asia

November 24, 2020 updated by: National Cancer Institute (NCI)

A Multi-Center International Hospital-Based Case-Control Study of Lymphoma in Asia (AsiaLymph)

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

13433

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Hexi District, China, 300060
        • Tianjin Medical University Cancer Institute & Hospital
      • Sichuan, China, 610041
        • West China Hospital of Sichuan University
  • Hong Kong
      • Sai Ying Poon, Hong Kong
        • Queen Mary Hospital
  • Taiwan
      • Dalin Town, Taiwan
        • Buddhis Dalin Tzu Chi General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The population of this study are Asian cases with lymphoid or myeloid neoplasma and controls with selected non-cancer diagnosis who were hospitalized in Hong Kong, Chengdu and Tianjin of Mainland China, and Taiwan.@@@

Description

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Cases
Asian cases with lymphoid or myeloid neoplasma
Controls
Controls with selected non-cancer diagnosis who were hospitalized in Hong Kong, Chengdu and Tianjin of Mainland China, and Taiwan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of chemical exposures and genetic susceptibility
Time Frame: 2020
A large-scale evaluation of genes associated with lymphoma in Asian populations that parallels efforts being conducted in Caucasian populations (e.g., currently a genome-wide association study (GWAS)) would be particularly informative because of Asian population genetic differences in patterns of LD and local haplotype structure.
2020
Explore relationship between other factors (viral infections, UV exposure, medical conditions, and lifestyle factors and non-Hodgkin Lymphoma
Time Frame: 2020
Other factors potentially related to NHL, such as viral infections, UV exposure, medical conditions, and other lifestyle factors will also beexplored.
2020

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 5, 2011

Primary Completion (Actual)

July 10, 2018

Study Completion (Actual)

July 10, 2018

Study Registration Dates

First Submitted

April 21, 2012

First Submitted That Met QC Criteria

April 21, 2012

First Posted (Estimate)

April 24, 2012

Study Record Updates

Last Update Posted (Actual)

November 27, 2020

Last Update Submitted That Met QC Criteria

November 24, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 999911206
  • 11-C-N206

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Lymphoma, Follicular

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Belarus

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe