- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00342264
A Nested Case-Control Study of Lung Cancer and Diesel Exhaust Among Non-Metal Miners
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.
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Maryland
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Rockville, Maryland, United States, 20850
- Westat Inc
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
- INCLUSION AND EXCLUSION CRITERIA:
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).
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Lung cancer death
Time Frame: death
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Lung cancer death
|
death
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Debra Silverman, D.Sc., National Cancer Institute (NCI)
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 999999003
- OH99-C-N003
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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