Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00342264
Status:
COMPLETED
Last Update Posted:
2024-04-18
First Post:
2006-06-19
Brief Title:
A Nested Case-Control Study of Lung Cancer and Diesel Exhaust Among Non-Metal Miners
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Diesel Exhaust in Miners Study
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor 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 NCINIOSH Interagency Agreement First a retrospective cohort mortality study of about 8200 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 subjects 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
NCI and NIOSH are collaborating on two related studies of diesel exhaust under the NCINIOSH Interagency Agreement First a retrospective cohort mortality study of about 8200 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 subjects 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 andor 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 NCINIOSH Interagency Agreement First a retrospective cohort mortality study of about 8200 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 subjects 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
NCI and NIOSH are collaborating on two related studies of diesel exhaust under the NCINIOSH Interagency Agreement First a retrospective cohort mortality study of about 8200 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 subjects 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| OH99-C-N003 | None | None | None |