A Nested Case-Control Study of Lung Cancer and Diesel Exhaust Among Non-Metal Miners



Status:Recruiting
Conditions:Lung Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 85
Updated:11/21/2018
Start Date:January 12, 1999
Contact:Debra Silverman, D.Sc.
Email:silvermd@epndce.nci.nih.gov
Phone:(301) 435-4716

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Diesel Exhaust Among 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.

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.

- 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).
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Morgantown, WV
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