Non-Hodgkin's LymphomaNCT00341952
Interdisciplinary Case-Control Study of Non-Hodgkin's Lymphoma
An observational study of Non-Hodgkin's Lymphoma, run by National Cancer Institute (NCI) at 4 sites in United States.
Trial summary
Non-Hodgkin's lymphoma (NHL) incidence rates have risen three percent per year in the U.S. for four decades. Mortality from NHL has risen 1.6 percent, compared with 0.2 percent for all cancers combined. Read more about this study
- Who is it for?
- Ages 20 to 74 years
- Conditions the study is for
- Non-Hodgkin's Lymphoma
- How many people
- 2,378 participants
- Where
- 4 sitesUnited States
- Study dates
- 15 Apr 1998to 17 Apr 2007
- 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 20 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Residents of participating SEER registries
Who may be able to join
None listed.
Who cannot join
- Individuals must not be previously diagnosed with NHL.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Wayne State University Hutzel Hospital
Detroit, Michigan, 48201
University of Iowa
Iowa City, Iowa, 52242
University of Southern California
Los Angeles, California, 90033
University of Washington
Seattle, Washington, 98195
About this study
Non-Hodgkin's lymphoma (NHL) incidence rates have risen three percent per year in the U.S. for four decades. Mortality from NHL has risen 1.6 percent, compared with 0.2 percent for all cancers combined. This epidemic curve appears in both sexes and around the world, suggesting the possibility of an etiologic agent increasing in prevalence in the general environment. Recent research has identified several possible candidates including pesticides, other organochlorines, drinking water nitrates, and sunlight. There is an urgent need to evaluate whether these common exposures are contributing to the rapid rise in NHL, and to investigate other hypothesized risk factors such as viruses, medical conditions, hair dye use, and genetic factors. The purpose of this study is to examine the contribution to NHL risk of these important environmental, occupational, viral, medical, and personal exposures, and to pursue important leads emerging from on-going NHL research. This multidisciplinary, population-based case-control study will involve personal interviews to collect information on demographics, residential history, pesticide use, and occupational exposures; self-administered questionnaires to collect information on diet, family and medical history, and other exposures; tap water and carpet dust sampling to collect information on nitrate and pesticide exposures; and blood sampling for measurements of compounds in the serum, antibodies to viruses, and examination of genetic polymorphisms.
Read the detailed description
Non-Hodgkin's lymphoma (NHL) incidence rates have risen three percent per year in the U.S. for four decades. Mortality from NHL has risen 1.6 percent, compared with 0.2 percent for all cancers combined. This epidemic curve appears in both sexes and around the world, suggesting the possibility of an etiologic agent increasing in prevalence in the general environment. Recent research has identified several possible candidates including pesticides, other organochlorines, drinking water nitrates, and sunlight. There is an urgent need to evaluate whether these common exposures are contributing to the rapid rise in NHL, and to investigate other hypothesized risk factors such as viruses, medical conditions, hair dye use, and genetic factors. The purpose of this study is to examine the contribution to NHL risk of these important environmental, occupational, viral, medical, and personal exposures, and to pursue important leads emerging from on-going NHL research. This multidisciplinary, population-based case-control study will involve personal interviews to collect information on demographics, residential history, pesticide use, and occupational exposures; self-administered questionnaires to collect information on diet, family and medical history, and other exposures; tap water and carpet dust sampling to collect information on nitrate and pesticide exposures; and blood sampling for measurements of compounds in the serum, antibodies to viruses, and examination of genetic polymorphisms.
- Conditions
- Non-Hodgkin's Lymphoma
- Keywords
- Case-Control Study, Non-Hodgkin Lymphoma
- Medical subject headings
- Lymphoma, Non-Hodgkin
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 | individuals diagnosed with incident, first primary non-Hodgkin lymphoma | |
| Controls | individuals identified in the same geographical areas without non-Hodgkin lymphoma or othercancers |
What is being measured
The primary outcome is the main question the study is designed to answer.
No intervention. Observational study compares cases and controls.
non-Hodgkin lymphoma cases versus controls
Measured: at the time of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2006 (estimated)
- Study start15 Apr 1998
- Primary completion17 Apr 2007
- Study completion17 Apr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Non-Hodgkin's LymphomaStudies 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
- 2,378 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Nathaniel Rothman, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00341952
- Sponsor's protocol ID
- 999998022
- Other IDs
- OH98-C-N022
- Status last verified
- Nov 2020
- First submitted
- 19 Jun 2006
- Last updated
- 27 Nov 2020
- Results posted
- No
Publications
Gridley G, McLaughlin JK, Ekbom A, Klareskog L, Adami HO, Hacker DG, Hoover R, Fraumeni JF Jr. Incidence of cancer among patients with rheumatoid arthritis. J Natl Cancer Inst. 1993 Feb 17;85(4):307-11. doi: 10.1093/jnci/85.4.307.
PubMed 8426374Cantor KP, Blair A, Everett G, VanLier S, Burmeister L, Dick FR, Gibson RW, Schuman L. Hair dye use and risk of leukemia and lymphoma. Am J Public Health. 1988 May;78(5):570-1. doi: 10.2105/ajph.78.5.570.
PubMed 3354743Bentham G. Association between incidence of non-Hodgkin's lymphoma and solar ultraviolet radiation in England and Wales. BMJ. 1996 May 4;312(7039):1128-31. doi: 10.1136/bmj.312.7039.1128.
PubMed 8620128
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
- Interdisciplinary Case-Control Study of Non-Hodgkin's Lymphoma
- ClinicalTrials.gov ID
- NCT00341952
- Acronym / sponsor ID
- 999998022
- Conditions
- Non-Hodgkin's Lymphoma
- Keywords
- Case-Control Study, Non-Hodgkin Lymphoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,378 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 15 Apr 1998
- Primary completion
- 17 Apr 2007 (actual)
- Study completion
- 17 Apr 2007 (actual)
- First posted
- 21 Jun 2006 (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.
Non-Hodgkin's lymphoma (NHL) incidence rates have risen three percent per year in the U.S. for four decades. Mortality from NHL has risen 1.6 percent, compared with 0.2 percent for all cancers combined. This epidemic curve appears in both sexes and around the world, suggesting the possibility of an etiologic agent increasing in prevalence in the general environment. Recent research has identified several possible candidates including pesticides, other organochlorines, drinking water nitrates, and sunlight. There is an urgent need to evaluate whether these common exposures are contributing to the rapid rise in NHL, and to investigate other hypothesized risk factors such as viruses, medical conditions, hair dye use, and genetic factors. The purpose of this study is to examine the contribution to NHL risk of these important environmental, occupational, viral, medical, and personal exposures, and to pursue important leads emerging from on-going NHL research. This multidisciplinary, population-based case-control study will involve personal interviews to collect information on demographics, residential history, pesticide use, and occupational exposures; self-administered questionnaires to collect information on diet, family and medical history, and other exposures; tap water and carpet dust sampling to collect information on nitrate and pesticide exposures; and blood sampling for measurements of compounds in the serum, antibodies to viruses, and examination of genetic polymorphisms.
Detailed description
Non-Hodgkin's lymphoma (NHL) incidence rates have risen three percent per year in the U.S. for four decades. Mortality from NHL has risen 1.6 percent, compared with 0.2 percent for all cancers combined. This epidemic curve appears in both sexes and around the world, suggesting the possibility of an etiologic agent increasing in prevalence in the general environment. Recent research has identified several possible candidates including pesticides, other organochlorines, drinking water nitrates, and sunlight. There is an urgent need to evaluate whether these common exposures are contributing to the rapid rise in NHL, and to investigate other hypothesized risk factors such as viruses, medical conditions, hair dye use, and genetic factors. The purpose of this study is to examine the contribution to NHL risk of these important environmental, occupational, viral, medical, and personal exposures, and to pursue important leads emerging from on-going NHL research. This multidisciplinary, population-based case-control study will involve personal interviews to collect information on demographics, residential history, pesticide use, and occupational exposures; self-administered questionnaires to collect information on diet, family and medical history, and other exposures; tap water and carpet dust sampling to collect information on nitrate and pesticide exposures; and blood sampling for measurements of compounds in the serum, antibodies to viruses, and examination of genetic polymorphisms.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | –individuals diagnosed with incident, first primary non-Hodgkin lymphoma |
| Controls | – | –individuals identified in the same geographical areas without non-Hodgkin lymphoma or othercancers |
Who may qualify
- Ages
- 20 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Residents of participating SEER registries
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Individuals must not be previously diagnosed with NHL.
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
No intervention. Observational study compares cases and controls.
Time frame: at the time of enrollment
non-Hodgkin lymphoma cases versus controls
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 8426374Gridley G, McLaughlin JK, Ekbom A, Klareskog L, Adami HO, Hacker DG, Hoover R, Fraumeni JF Jr. Incidence of cancer among patients with rheumatoid arthritis. J Natl Cancer Inst. 1993 Feb 17;85(4):307-11. doi: 10.1093/jnci/85.4.307.
- Background: PubMed 3354743Cantor KP, Blair A, Everett G, VanLier S, Burmeister L, Dick FR, Gibson RW, Schuman L. Hair dye use and risk of leukemia and lymphoma. Am J Public Health. 1988 May;78(5):570-1. doi: 10.2105/ajph.78.5.570.
- Background: PubMed 8620128Bentham G. Association between incidence of non-Hodgkin's lymphoma and solar ultraviolet radiation in England and Wales. BMJ. 1996 May 4;312(7039):1128-31. doi: 10.1136/bmj.312.7039.1128.
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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.
Nathaniel Rothman, M.D. principal investigator
National Cancer Institute (NCI)
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Hodgkin's Lymphoma, run by National Cancer Institute (NCI) at 4 sites in United States.
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 0 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 United States. 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?
No intervention. Observational study compares cases and controls. (time frame: at the time of enrollment). 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 NCT00341952, which also lists 3 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.