Study of Lung Health Among Workers Exposed to Diesel Exhaust

NCT01867450 | Completed

• 2 other identifiers: 99991310113-C-N101
• Study Type: observational
• Target: 109
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Inflammation Biomarkers; mRNA Expression; nitroPAH Adducts

Keywords

Biomarkers; Deisel Exhaust; Occupational Exposure; Cross-Sectional Study

Outcome Measures

Primary Outcomes (2)

• Related markers to risk of lung cancer

  lung cancer related biomarkers

  2012-2034

• Inflammatory Effects

  inflammatory biomarkers

  2012-2034

Study Arms (1)

Biomarker Cross-section

Cross-sectional biomarker study in Chinese diesel workers

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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 .

You may not qualify if:

• None.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead
• Utrecht University: collaborator
• Boston University: collaborator
• University of Cincinnati: collaborator
• University of Southern California: collaborator
• Duke University: collaborator

Study Sites (1)

Chinese Center for Disease Control &amp; Prevention

Beijing, China

Location

Related Publications (3)

• 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.

  PMID: 17000751 BACKGROUND

• Gerlofs-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.

  PMID: 21126152 BACKGROUND

• Gordon 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.

  PMID: 22486347 BACKGROUND

Study Officials

• Qing Lan, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2013
• First Posted: June 4, 2013
• Study Start: March 28, 2013
• Primary Completion: March 31, 2013
• Study Completion: November 12, 2020
• Last Updated: November 13, 2020

Record last verified: 2020-11

Locations

CN (1)