Inflammation BiomarkersNCT01867450
Study of Lung Health Among Workers Exposed to Diesel Exhaust
An observational study of Inflammation Biomarkers and mRNA Expression, run by National Cancer Institute (NCI) at 1 site in China.
Trial summary
Background: Diesel fuel is the most commonly used fuel to power cars and trucks worldwide. However, diesel exhaust fumes can have harmful effects on the body. Researchers are interested in studying how diesel exhaust exposure can affect lung health. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Inflammation Biomarkers, mRNA Expression, nitroPAH Adducts
- How many people
- 109 participants
- Where
- 1 siteChina
- Study dates
- 28 Mar 2013to 12 Nov 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This is a cross-sectional molecular epidemiologic study of workers exposed to diesel exhaust in an enginetesting facility. These workers, all of whom are male, spend most of their shift in direct proximity to the engine being tested and as a consequence have potential for exposure to substantial levels of diesel exhaust. Fifty male workers will be selected who are non-smokers or light smokers (< 10 cigarettes per day) and who have worked in the testing facility for the longest amount of time. Fifty male controls, frequency-matched to the exposed workers by age and smoking status (i.e., never, former, current light smoking) will be identified in factories that work in the same local region of China with work processes that do not involve exposure to diesel exhaust, other types of particulates, or any known or suspected@@@genotoxic, hematotoxic, or immunotoxic chemicals.
Who may be able to join
- To be current workers in the diesel engine testing facility of a study factory in the selected region of China. All workers in this facility are male.
- Inclusion criteria for workers not exposed to diesel exhaust (controls):
- To be a current male worker in a selected control study factory, that does not have exposure to diesel exhaust or other types of particulates, or any known or suspected genotoxic, hematotoxic, or immunotoxic chemicals, who is comparable to workers working in the diesel engine testing facility by age and smoking status .
Who cannot join
- None.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Cross-Sectional Molecular Epidemiology Study of Occupational Exposure to Diesel Exhaust and Biomarkers in China
Background:
- Diesel fuel is the most commonly used fuel to power cars and trucks worldwide. However, diesel exhaust fumes can have harmful effects on the body. Researchers are interested in studying how diesel exhaust exposure can affect lung health. To study these effects, researchers will look at employees of a diesel truck engine testing facility in China. Some workers at this facility are exposed to high levels of diesel exhaust. This study will compare tests and monitoring information from a group of highly exposed workers and a similar group of unexposed comparable controls.
Read more
Objectives:
- To study the effects of diesel exhaust on lung health.
Eligibility:
- Participants will be drawn from a diesel truck engine testing facility and other workplaces in China.
- Individuals at least 18 years of age who work in workshops with diesel fuel.
- Individuals at least 18 years of age who work in workshops that do not use diesel fuel.
Design:
- Depending on what type of factory study subjects work in, participants will wear personal air pumps and small badges on their clothing on one or more days. This equipment will measure particles, chemicals, and other compounds in the air. This information plus other information collected in the study including workplace practices will be used to estimate exposure to diesel exhaust among study subjects.
- Participants will provide a number of study samples. These samples include blood, urine, and sputum. To collect other samples, participants will also have a mouth rinse, cheek cell scrapes, and nasal cell scrapes. They will also have a physical exam.
- Treatment will not be provided as part of this study. Participants will receive financial compensation for participation in the study.
Read the detailed description
The Occupational and Environmental Epidemiology Branch has a long history of conducting research on the carcinogenicity of diesel exhaust exposure. Most recently, a 20 year effort in collaboration with NIOSH has resulted in a seminal publication showing a dose-response relationship between air levels of elemental carbon, a surrogate for diesel exhaust, and risk of lung cancer in underground miners (Silverman et al. 2012). This study made a critically important contribution to the recent IARC decision to categorize diesel exhaust as a Group I carcinogen. Despite years of experimental studies, and small and limited workplace biomarker studies, there are still major uncertainties about the mechanism by which diesel exhaust causes lung cancer in humans. To address this gap in knowledge, we have identified a diesel truck engine testing facility in China, where workers are exposed to very high levels of diesel exhaust, which provides what we believe to be the very best opportunity to conduct a study to provide new insights into diesel exhaust carcinogenesis. We propose to carry out a cross-sectional molecular epidemiology study of 50 highly exposed workers in this facility and 50 unexposed comparable controls to study potential mechanisms of action for diesel exhaust exposure. These include upper-airway nitro-PAH-DNA adducts; inflammatory effects determined by alterations in cytokines and related markers that have been linked prospectively to risk of lung cancer; and alterations in gene expression in a wide range of potentially relevant pathways.
- Conditions
- Inflammation Biomarkers, mRNA Expression, nitroPAH Adducts
- Keywords
- Biomarkers, Deisel Exhaust, Occupational Exposure, Cross-Sectional Study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Biomarker Cross-section | Cross-sectional biomarker study in Chinese diesel workers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Related markers to risk of lung cancer
lung cancer related biomarkers
Measured: 2012-2034
Inflammatory Effects
inflammatory biomarkers
Measured: 2012-2034
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2013 (estimated)
- Study start28 Mar 2013
- Primary completion31 Mar 2013
- Study completion12 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Inflammation BiomarkersStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Collaborators
- Utrecht University, Boston University, University of Cincinnati, University of Southern California, Duke University
- Responsible party
- Sponsor
- Investigators
- Qing Lan, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01867450
- Sponsor's protocol ID
- 999913101
- Other IDs
- 13-C-N101
- Status last verified
- Nov 2020
- First submitted
- 10 May 2013
- Last updated
- 13 Nov 2020
- Results posted
- No
Publications
Chang JT, Nevins JR. GATHER: a systems approach to interpreting genomic signatures. Bioinformatics. 2006 Dec 1;22(23):2926-33. doi: 10.1093/bioinformatics/btl483. Epub 2006 Sep 25.
PubMed 17000751Gerlofs-Nijland ME, Totlandsdal AI, Kilinc E, Boere AJ, Fokkens PH, Leseman DL, Sioutas C, Schwarze PE, Spronk HM, Hadoke PW, Miller MR, Cassee FR. Pulmonary and cardiovascular effects of traffic-related particulate matter: 4-week exposure of rats to roadside and diesel engine exhaust particles. Inhal Toxicol. 2010 Dec;22(14):1162-73. doi: 10.3109/08958378.2010.531062.
PubMed 21126152Gordon CJ, Schladweiler MC, Krantz T, King C, Kodavanti UP. Cardiovascular and thermoregulatory responses of unrestrained rats exposed to filtered or unfiltered diesel exhaust. Inhal Toxicol. 2012 Apr;24(5):296-309. doi: 10.3109/08958378.2012.670811.
PubMed 22486347
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cross-Sectional Molecular Epidemiology Study of Occupational Exposure to Diesel Exhaust and Biomarkers in China
- ClinicalTrials.gov ID
- NCT01867450
- Acronym / sponsor ID
- 999913101
- Conditions
- Inflammation Biomarkers, mRNA Expression, nitroPAH Adducts
- Keywords
- Biomarkers, Deisel Exhaust, Occupational Exposure, Cross-Sectional Study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Collaborators
- Utrecht University, Boston University, University of Cincinnati, University of Southern California, Duke University
- Study start
- 28 Mar 2013 (actual)
- Primary completion
- 31 Mar 2013 (actual)
- Study completion
- 12 Nov 2020 (actual)
- First posted
- 4 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
- Diesel fuel is the most commonly used fuel to power cars and trucks worldwide. However, diesel exhaust fumes can have harmful effects on the body. Researchers are interested in studying how diesel exhaust exposure can affect lung health. To study these effects, researchers will look at employees of a diesel truck engine testing facility in China. Some workers at this facility are exposed to high levels of diesel exhaust. This study will compare tests and monitoring information from a group of highly exposed workers and a similar group of unexposed comparable controls.
Objectives:
- To study the effects of diesel exhaust on lung health.
Eligibility:
- Participants will be drawn from a diesel truck engine testing facility and other workplaces in China.
- Individuals at least 18 years of age who work in workshops with diesel fuel.
- Individuals at least 18 years of age who work in workshops that do not use diesel fuel.
Design:
- Depending on what type of factory study subjects work in, participants will wear personal air pumps and small badges on their clothing on one or more days. This equipment will measure particles, chemicals, and other compounds in the air. This information plus other information collected in the study including workplace practices will be used to estimate exposure to diesel exhaust among study subjects.
- Participants will provide a number of study samples. These samples include blood, urine, and sputum. To collect other samples, participants will also have a mouth rinse, cheek cell scrapes, and nasal cell scrapes. They will also have a physical exam.
- Treatment will not be provided as part of this study. Participants will receive financial compensation for participation in the study.
Detailed description
The Occupational and Environmental Epidemiology Branch has a long history of conducting research on the carcinogenicity of diesel exhaust exposure. Most recently, a 20 year effort in collaboration with NIOSH has resulted in a seminal publication showing a dose-response relationship between air levels of elemental carbon, a surrogate for diesel exhaust, and risk of lung cancer in underground miners (Silverman et al. 2012). This study made a critically important contribution to the recent IARC decision to categorize diesel exhaust as a Group I carcinogen. Despite years of experimental studies, and small and limited workplace biomarker studies, there are still major uncertainties about the mechanism by which diesel exhaust causes lung cancer in humans. To address this gap in knowledge, we have identified a diesel truck engine testing facility in China, where workers are exposed to very high levels of diesel exhaust, which provides what we believe to be the very best opportunity to conduct a study to provide new insights into diesel exhaust carcinogenesis. We propose to carry out a cross-sectional molecular epidemiology study of 50 highly exposed workers in this facility and 50 unexposed comparable controls to study potential mechanisms of action for diesel exhaust exposure. These include upper-airway nitro-PAH-DNA adducts; inflammatory effects determined by alterations in cytokines and related markers that have been linked prospectively to risk of lung cancer; and alterations in gene expression in a wide range of potentially relevant pathways.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Biomarker Cross-section | – | –Cross-sectional biomarker study in Chinese diesel workers |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is a cross-sectional molecular epidemiologic study of workers exposed to diesel exhaust in an enginetesting facility. These workers, all of whom are male, spend most of their shift in direct proximity to the engine being tested and as a consequence have potential for exposure to substantial levels of diesel exhaust. Fifty male workers will be selected who are non-smokers or light smokers (< 10 cigarettes per day) and who have worked in the testing facility for the longest amount of time. Fifty male controls, frequency-matched to the exposed workers by age and smoking status (i.e., never, former, current light smoking) will be identified in factories that work in the same local region of China with work processes that do not involve exposure to diesel exhaust, other types of particulates, or any known or suspected@@@genotoxic, hematotoxic, or immunotoxic chemicals.
Key inclusion criteria (3 listed)
- To be current workers in the diesel engine testing facility of a study factory in the selected region of China. All workers in this facility are male.
- To be a current male worker in a selected control study factory, that does not have exposure to diesel exhaust or other types of particulates, or any known or suspected genotoxic, hematotoxic, or immunotoxic chemicals, who is comparable to workers working in the diesel engine testing facility by age and smoking status .
Key exclusion criteria (1 listed)
- None.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Related markers to risk of lung cancer
Time frame: 2012-2034
lung cancer related biomarkers
Inflammatory Effects
Time frame: 2012-2034
inflammatory biomarkers
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2020.
- Background: PubMed 17000751Chang JT, Nevins JR. GATHER: a systems approach to interpreting genomic signatures. Bioinformatics. 2006 Dec 1;22(23):2926-33. doi: 10.1093/bioinformatics/btl483. Epub 2006 Sep 25.
- Background: PubMed 21126152Gerlofs-Nijland ME, Totlandsdal AI, Kilinc E, Boere AJ, Fokkens PH, Leseman DL, Sioutas C, Schwarze PE, Spronk HM, Hadoke PW, Miller MR, Cassee FR. Pulmonary and cardiovascular effects of traffic-related particulate matter: 4-week exposure of rats to roadside and diesel engine exhaust particles. Inhal Toxicol. 2010 Dec;22(14):1162-73. doi: 10.3109/08958378.2010.531062.
- Background: PubMed 22486347Gordon CJ, Schladweiler MC, Krantz T, King C, Kodavanti UP. Cardiovascular and thermoregulatory responses of unrestrained rats exposed to filtered or unfiltered diesel exhaust. Inhal Toxicol. 2012 Apr;24(5):296-309. doi: 10.3109/08958378.2012.670811.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qing Lan, M.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammation Biomarkers and mRNA Expression, run by National Cancer Institute (NCI) at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Related markers to risk of lung cancer (time frame: 2012-2034). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01867450, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2020.