NCT00342264Completed
A Nested Case-Control Study of Lung Cancer and Diesel Exhaust Among Non-Metal Miners
Diesel Exhaust in Miners Study
Source: ClinicalTrials.gov · Last updated 18 Apr 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 1187 (actual)
- First submitted
- 19 Jun 2006
- Start date
- 12 Jan 1999
- Primary completion date
- 16 Apr 2024
- Lead sponsor
- National Cancer Institute (NCI)
- Diseases
- Lung cancer
- NCT number
- NCT00342264
What you commit to
- Study type: Observational
- Participants enrolled: 1187
- From 12 Jan 1999 to the primary completion date, 16 Apr 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- 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).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Westat, Inc. Coordinator of this site? Confirm its status | Rockville | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.