Lung CancerNCT00342264
A Nested Case-Control Study of Lung Cancer and Diesel Exhaust Among Non-Metal Miners
An observational study of Lung Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Diesel exhaust has been classified as a probable carcinogen by the International Agency for Research on Cancer and as a potential carcinogen by the National Institute for Occupational Safety and Health (NIOSH). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- How many people
- 1,187 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jan 1999to 16 Apr 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The Diesel Exhaust in Miners Study (DEMS) is a cohort study of 12,315 nonmetal miners employed in 8 study mines (3 trona mines in Wyoming, 3 potash mines in New Mexico, 1 limestone mine in Missouri and 1 salt mine in Ohio), coupled with a nested case-control study of lung cancer to obtain information on smoking and other potential confounders from telephone interviews with next of kin of all cases and dead controls and direct interviews with living controls.
Who may be able to join
- Subjects will be identified from all 10 mines participating in the cohort study.
- Cases from each mine will be lung cancer deaths as specified on the death certificate occurring among members of the cohort working at the mine between the date the mine was dieselized and December 31, 1996.
- Children will be excluded from participating.
- We will exclude cases that are found either not likely to be carcinoma of the lung or metastatic to the lung by slide review or pathology report.
- Four controls will be selected for each case by random sampling from among all members of the cohort who were alive prior to the day the case died.
- Controls will be individually matched to the case on mine, gender, race/ethnicity, and year of birth (within 5 years).
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diesel Exhaust in Miners Study
Diesel exhaust has been classified as a probable carcinogen by the International Agency for Research on Cancer and as a potential carcinogen by the National Institute for Occupational Safety and Health (NIOSH). The carcinogenicity of this pollutant is of concern not only for the one million workers who are exposed occupationally, but also for the general population. Over 30 epidemiologic studies of diesel exhaust exposure have been performed, and the results suggest an increase in lung cancer risk. However, the association is not well defined. Past studies have suffered from the use of crude indicators of exposure, inadequate control of confounding, and/or short follow-up periods, low exposure levels, and small numbers of observations.
NCI and NIOSH are collaborating on two related studies of diesel exhaust under the NCI/NIOSH Interagency Agreement. First, a retrospective cohort mortality study of about 8,200 non-metal miners will be performed to investigate lung cancer mortality in relation to quantitative measures of diesel exhaust exposure, and to determine whether there is evidence of elevated mortality from other causes of death among diesel exhaust exposed miners. The retrospective cohort study will be performed using existing records and information and has been exempted from IRB review. NIOSH is the lead agency on the retrospective cohort study.
The proposed study is a case-control study nested in the retrospective cohort of non-metal miners. The study is expected to include at least 160 members of the cohort who died from lung cancer and four matched controls for each case. Using a structured questionnaire, detailed information will be collected on each subject's lifetime exposure to diesel exhaust, as well as information on smoking and other confounders. This information will allow investigators to examine the association between lung cancer and different quantitative measures of diesel exhaust exposure, adjusted for smoking and other potential confounders.
Read the detailed description
Diesel exhaust has been classified as a probable carcinogen by the International Agency for Research on Cancer and as a potential carcinogen by the National Institute for Occupational Safety and Health (NIOSH). The carcinogenicity of this pollutant is of concern not only for the one million workers who are exposed occupationally, but also for the general population. Over 30 epidemiologic studies of diesel exhaust exposure have been performed, and the results suggest an increase in lung cancer risk. However, the association is not well defined. Past studies have suffered from the use of crude indicators of exposure, inadequate control of confounding, and/or short follow-up periods, low exposure levels, and small numbers of observations.
NCI and NIOSH are collaborating on two related studies of diesel exhaust under the NCI/NIOSH Interagency Agreement. First, a retrospective cohort mortality study of about 8,200 non-metal miners will be performed to investigate lung cancer mortality in relation to quantitative measures of diesel exhaust exposure, and to determine whether there is evidence of elevated mortality from other causes of death among diesel exhaust exposed miners. The retrospective cohort study will be performed using existing records and information and has been exempted from IRB review. NIOSH is the lead agency on the retrospective cohort study.
The proposed study is a case-control study nested in the retrospective cohort of non-metal miners. The study is expected to include at least 160 members of the cohort who died from lung cancer and four matched controls for each case. Using a structured questionnaire, detailed information will be collected on each subject's lifetime exposure to diesel exhaust, as well as information on smoking and other confounders. This information will allow investigators to examine the association between lung cancer and different quantitative measures of diesel exhaust exposure, adjusted for smoking and other potential confounders.
- Conditions
- Lung Cancer
- Keywords
- Lung Cancer, Occupational Cohort, Diesel Exhaust, Natural History
- Medical subject headings
- Lung Neoplasms
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 |
|---|---|---|
| 1 | The study cohort will be comprised of underground, and surface workers (excluding administrative workers) who have been employed in the candidate non-metal mines for at least one year during the period between the date of dieselization of each mine and December 31, 1996. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung cancer death
Lung cancer death
Measured: death
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 start12 Jan 1999
- Primary completion16 Apr 2024
- Study completion16 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,187 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Debra Silverman, D.Sc., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00342264
- Sponsor's protocol ID
- 999999003
- Other IDs
- OH99-C-N003
- Status last verified
- Apr 2024
- First submitted
- 19 Jun 2006
- Last updated
- 18 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diesel Exhaust in Miners Study
- ClinicalTrials.gov ID
- NCT00342264
- Acronym / sponsor ID
- 999999003
- Conditions
- Lung Cancer
- Keywords
- Lung Cancer, Occupational Cohort, Diesel Exhaust, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,187 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 12 Jan 1999 (actual)
- Primary completion
- 16 Apr 2024 (actual)
- Study completion
- 16 Apr 2024 (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.
Diesel exhaust has been classified as a probable carcinogen by the International Agency for Research on Cancer and as a potential carcinogen by the National Institute for Occupational Safety and Health (NIOSH). The carcinogenicity of this pollutant is of concern not only for the one million workers who are exposed occupationally, but also for the general population. Over 30 epidemiologic studies of diesel exhaust exposure have been performed, and the results suggest an increase in lung cancer risk. However, the association is not well defined. Past studies have suffered from the use of crude indicators of exposure, inadequate control of confounding, and/or short follow-up periods, low exposure levels, and small numbers of observations.
NCI and NIOSH are collaborating on two related studies of diesel exhaust under the NCI/NIOSH Interagency Agreement. First, a retrospective cohort mortality study of about 8,200 non-metal miners will be performed to investigate lung cancer mortality in relation to quantitative measures of diesel exhaust exposure, and to determine whether there is evidence of elevated mortality from other causes of death among diesel exhaust exposed miners. The retrospective cohort study will be performed using existing records and information and has been exempted from IRB review. NIOSH is the lead agency on the retrospective cohort study.
The proposed study is a case-control study nested in the retrospective cohort of non-metal miners. The study is expected to include at least 160 members of the cohort who died from lung cancer and four matched controls for each case. Using a structured questionnaire, detailed information will be collected on each subject's lifetime exposure to diesel exhaust, as well as information on smoking and other confounders. This information will allow investigators to examine the association between lung cancer and different quantitative measures of diesel exhaust exposure, adjusted for smoking and other potential confounders.
Detailed description
Diesel exhaust has been classified as a probable carcinogen by the International Agency for Research on Cancer and as a potential carcinogen by the National Institute for Occupational Safety and Health (NIOSH). The carcinogenicity of this pollutant is of concern not only for the one million workers who are exposed occupationally, but also for the general population. Over 30 epidemiologic studies of diesel exhaust exposure have been performed, and the results suggest an increase in lung cancer risk. However, the association is not well defined. Past studies have suffered from the use of crude indicators of exposure, inadequate control of confounding, and/or short follow-up periods, low exposure levels, and small numbers of observations.
NCI and NIOSH are collaborating on two related studies of diesel exhaust under the NCI/NIOSH Interagency Agreement. First, a retrospective cohort mortality study of about 8,200 non-metal miners will be performed to investigate lung cancer mortality in relation to quantitative measures of diesel exhaust exposure, and to determine whether there is evidence of elevated mortality from other causes of death among diesel exhaust exposed miners. The retrospective cohort study will be performed using existing records and information and has been exempted from IRB review. NIOSH is the lead agency on the retrospective cohort study.
The proposed study is a case-control study nested in the retrospective cohort of non-metal miners. The study is expected to include at least 160 members of the cohort who died from lung cancer and four matched controls for each case. Using a structured questionnaire, detailed information will be collected on each subject's lifetime exposure to diesel exhaust, as well as information on smoking and other confounders. This information will allow investigators to examine the association between lung cancer and different quantitative measures of diesel exhaust exposure, adjusted for smoking and other potential confounders.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –The study cohort will be comprised of underground, and surface workers (excluding administrative workers) who have been employed in the candidate non-metal mines for at least one year during the period between the date of dieselization of each mine and December 31, 1996. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The Diesel Exhaust in Miners Study (DEMS) is a cohort study of 12,315 nonmetal miners employed in 8 study mines (3 trona mines in Wyoming, 3 potash mines in New Mexico, 1 limestone mine in Missouri and 1 salt mine in Ohio), coupled with a nested case-control study of lung cancer to obtain information on smoking and other potential confounders from telephone interviews with next of kin of all cases and dead controls and direct interviews with living controls.
Key inclusion criteria (6 listed)
- Subjects will be identified from all 10 mines participating in the cohort study.
- Cases from each mine will be lung cancer deaths as specified on the death certificate occurring among members of the cohort working at the mine between the date the mine was dieselized and December 31, 1996.
- Children will be excluded from participating.
- We will exclude cases that are found either not likely to be carcinoma of the lung or metastatic to the lung by slide review or pathology report.
- Four controls will be selected for each case by random sampling from among all members of the cohort who were alive prior to the day the case died.
Key exclusion criteria (0 listed)
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
Lung cancer death
Time frame: death
Lung cancer death
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 18 Apr 2024.
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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.
Debra Silverman, D.Sc. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by National Cancer Institute (NCI) at 1 site 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 6 inclusion and 0 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 18 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Lung cancer death (time frame: death). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Apr 2024.