Clinical trial NCT00342264: A Nested Case-Control Study of Lung Cancer and Diesel Exhaust Among Non-Metal Miners
Official title: Diesel Exhaust in Miners Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Keywords: Lung Cancer
Occupational Cohort
Diesel Exhaust
Natural History
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2006-06-21
Enrollment: 1187
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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). 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.

Eligibility criteria: * 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).

Primary outcomes:
measure: Lung cancer death
timeFrame: death
Secondary outcomes:
Other outcomes:
Locations:
city: Rockville
country: United States
facility: Westat Inc
state: Maryland
Study officials:
affiliation: National Cancer Institute (NCI)
name: Debra Silverman, D.Sc.
role: PRINCIPAL_INVESTIGATOR
References: