Lymphoma, FollicularNCT01584141
Study of Lymphoma in Asia
An observational study of Lymphoma, Follicular and Lymphoma, Non-Hodgkin, run by National Cancer Institute (NCI) at 4 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Lymphoma, Follicular, Lymphoma, Non-Hodgkin, Multiple Myleoma
- How many people
- 13,433 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 5 Jul 2011to 10 Jul 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.@@@
Who may be able to join
- 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.
Who cannot join
- Cases with previous diagnosis of lymphoma, such as acute lymphoblastic lymphoma, multiple myeloma, chronic lymphocytic leukemia, and non-Hodgkin lymphoma, are ineligible.
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
China2 sites
Tianjin Medical University Cancer Institute & Hospital
Hexi District, 300060
West China Hospital of Sichuan University
Sichuan, 610041
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Lymphoma, Follicular, Lymphoma, Non-Hodgkin, Multiple Myleoma, Lympocytic, Follicular, Leukemia, Hodgkin Lymphoma
- Keywords
- Leukemia, Lymphoma, Occupational Epidemiology, Molecular Epidemiology, Genetic Polymorphisms
- Medical subject headings
- Lymphoma, Follicular, Lymphoma, Non-Hodgkin, Leukemia, Hodgkin Disease, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of chemical exposures and genetic susceptibility
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.
Measured: 2020
Explore relationship between other factors (viral infections, UV exposure, medical conditions, and lifestyle factors and non-Hodgkin Lymphoma
Other factors potentially related to NHL, such as viral infections, UV exposure, medical conditions, and other lifestyle factors will also beexplored.
Measured: 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2012 (estimated)
- Study start5 Jul 2011
- Primary completion10 Jul 2018
- Study completion10 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lymphoma, FollicularStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 13,433 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Qing Lan, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01584141
- Sponsor's protocol ID
- 999911206
- Other IDs
- 11-C-N206
- Status last verified
- Nov 2020
- First submitted
- 21 Apr 2012
- Last updated
- 27 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Anderson LA, Pfeiffer R, Warren JL, Landgren O, Gadalla S, Berndt SI, Ricker W, Parsons R, Wheeler W, Engels EA. Hematopoietic malignancies associated with viral and alcoholic hepatitis. Cancer Epidemiol Biomarkers Prev. 2008 Nov;17(11):3069-75. doi: 10.1158/1055-9965.EPI-08-0408. Epub 2008 Oct 28.
PubMed 18957521Aoki R, Karube K, Sugita Y, Nomura Y, Shimizu K, Kimura Y, Hashikawa K, Suefuji N, Kikuchi M, Ohshima K. Distribution of malignant lymphoma in Japan: analysis of 2260 cases, 2001-2006. Pathol Int. 2008 Mar;58(3):174-82. doi: 10.1111/j.1440-1827.2007.02207.x.
PubMed 18251781
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center International Hospital-Based Case-Control Study of Lymphoma in Asia (AsiaLymph)
- ClinicalTrials.gov ID
- NCT01584141
- Acronym / sponsor ID
- 999911206
- Conditions
- Lymphoma, Follicular, Lymphoma, Non-Hodgkin, Multiple Myleoma, Lympocytic, Follicular, Leukemia, Hodgkin Lymphoma
- Keywords
- Leukemia, Lymphoma, Occupational Epidemiology, Molecular Epidemiology, Genetic Polymorphisms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13,433 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 5 Jul 2011 (actual)
- Primary completion
- 10 Jul 2018 (actual)
- Study completion
- 10 Jul 2018 (actual)
- First posted
- 24 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.@@@
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Cases with previous diagnosis of lymphoma, such as acute lymphoblastic lymphoma, multiple myeloma, chronic lymphocytic leukemia, and non-Hodgkin lymphoma, are ineligible.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2020.
- Background: PubMed 18957521Anderson LA, Pfeiffer R, Warren JL, Landgren O, Gadalla S, Berndt SI, Ricker W, Parsons R, Wheeler W, Engels EA. Hematopoietic malignancies associated with viral and alcoholic hepatitis. Cancer Epidemiol Biomarkers Prev. 2008 Nov;17(11):3069-75. doi: 10.1158/1055-9965.EPI-08-0408. Epub 2008 Oct 28.
- Background: PubMed 18251781Aoki R, Karube K, Sugita Y, Nomura Y, Shimizu K, Kimura Y, Hashikawa K, Suefuji N, Kikuchi M, Ohshima K. Distribution of malignant lymphoma in Japan: analysis of 2260 cases, 2001-2006. Pathol Int. 2008 Mar;58(3):174-82. doi: 10.1111/j.1440-1827.2007.02207.x.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qing Lan, M.D. principal investigator
National Cancer Institute (NCI)
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphoma, Follicular and Lymphoma, Non-Hodgkin, run by National Cancer Institute (NCI) at 4 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China, Hong Kong, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of chemical exposures and genetic susceptibility (time frame: 2020). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01584141, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2020.