- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00481611
Cancer Markers Associated With Occupational Exposure to Trichloroethylene
A Cross-Sectional Study of Occupational Exposure to Trichloroethylene, Chromosomal Aberrations, and Related Biomarkers in Guangdong, China
Background:
- Trichloroethylene (TCE) is a solvent used in many medical and industrial processes.
- TCE is a carcinogen (causes cancer) in rats, but its carcinogenicity in humans is unclear. There is some evidence of increased liver and kidney cancers and of an association with non-Hodgkin lymphoma in studies of workers exposed to TCE.
- The carcinogenicity and regulation of TCE is a matter of continuing debate.
Objectives:
- To determine if TCE exposure is associated with higher levels of genetic aberrations in certain white blood cells called lymphocytes.
- To determine if TCE exposure affects lymphocyte subsets and levels of certain hormones called cytokines.
Eligibility: Workers exposed to two different levels of exposure to TCE and unexposed workers in Guangdong Province, China.
Design:
- 45 workers exposed to more than 25 parts per million (ppm) TCE, 30 workers exposed to from 10 to less than 25 ppm TCE and 45 unexposed workers will be enrolled.
- Subjects wear small instruments at work that measure chemicals in the air for 1 or 2 days during the 2-week study period. Exposed workers also wear several small skin patches on one of the two days.
- Subjects provide blood and urine samples.
- Subjects answer a questionnaire about work, smoking and drinking, use of medicines, medical history, general health, hobbies, and exposure to radiation and exposure to various substances at home.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Guangzhou, China
- Guangdong National Poison Control Center (NPCC)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
- INCLUSION CRITERIA:
A total of 45 workers exposed to greater than 25 ppm TCE, 30 workers exposed from 10 to less than 25 ppm TCE, and 45 unexposed workers will be enrolled.
We will identify 45 workers from 3 factories who are exposed to greater than 25 ppm TCE. Our colleagues at the Guangdong NPCC will visit potential study factories and carry out air measurements for TCE, epichlorhydrin, methylene chloride, perchloroethylene and benzene. Factories will be selected that use only TCE for degreasing processes, have minimal co-exposures present in the same part of the workplace where TCE is used, and have used a stable manufacturing process for the past five years.
Workers will be chosen who work in part of the factory with TCE exposure, have worked for at least one year in the factory doing the same job in the same part of the manufacturing process, and have not been exposed to other genotoxic, hematotoxic, or immunotoxic compounds in any workplace. We will enroll 45 controls, who have no history of occupational exposure to TCE or to any other genotoxic, hematotoxic or immunotoxic chemicals.
EXCLUSION CRITERIA:
History of cancer, chemotherapy with DNA-damaging or immunotoxic agents, and medical treatment with ionizing radiation.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hematotoxicity change
Time Frame: 2006-2034
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The primary goal of the study is to determine if TCE exposure is associated with higher levels of chromosomal aberrations in peripherallymphocytes.
The additional goals of the study, to be funded by extramural collaborators, are to evaluate TCE urinary metabolite patterns, alterations in specific types of chromosomal aberrations that have been detected in NHL and other hematopoietic malignancies, and alterations in mRNA expression and the proteome.
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2006-2034
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Immune function
Time Frame: 2006-2034
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A secondary goal of the study is to determine if TCE exposure alters plasma cytokine levels and lymphocyte subsets.
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2006-2034
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 999906176
- 06-C-N176
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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