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NCT Number: NCT00342264

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Westat Inc

Rockville, Maryland, 20850, United States

About this 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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).

Treatment and study plan

Primary outcomes

  1. Lung cancer death

    Time frame: death

    Lung cancer death

Sponsors and collaborators

Lead sponsor

National Cancer Institute (NCI)

Nih

Registry information

Official study title

Diesel Exhaust in Miners Study

Important dates

Study start
1999
Primary completion
2024
Study completion
2024
First posted
Jun 21, 2006
Registry last updated
Apr 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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