Cancer Markers Associated With Occupational Exposure to Trichloroethylene

NCT00481611 | Completed

• 2 other identifiers: 99990617606-C-N176
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Industrial Hygiene; Epidemiology; Neoplasms

Keywords

Industry Hygiene; Molecular Epidemiology; Cancer Susceptibility; Genotoxicity; Immune Function; Cancer Susceptability

Outcome Measures

Primary Outcomes (2)

• Hematotoxicity change

  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.

  2006-2034

• Immune function

  A secondary goal of the study is to determine if TCE exposure alters plasma cytokine levels and lymphocyte subsets.

  2006-2034

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

We carried out a cross-sectional study of workers currently exposed to TCE in the six study factories with TCE cleaning operations and unexposed controls. Control workers were enrolled from two clothes manufacturing factories, one food production factory and a hospital that did not use TCE and were in the same geographic region as the factories that used TCE. Exclusion criteria for both TCE-exposed and control workers were history of cancer, chemotherapy and radiotherapy, as well as previous occupations with notable exposure to benzene, butadiene, styrene and/or ionizing radiation.

You may qualify if:

• 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.

You may not qualify if:

• History of cancer, chemotherapy with DNA-damaging or immunotoxic agents, and medical treatment with ionizing radiation.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Guangdong National Poison Control Center (NPCC)

Guangzhou, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Plasma, Red blood cells, whole blood, cryopreserved lymphocytes, cryopreserved granulocytes, FISH cells, FISH slides, RNAlater, supernatant, buccal pellets, buccal slides, serum, clot, LeukLock, buffy coat, urine.

MeSH Terms

Conditions

Neoplasms

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: June 1, 2007
• First Posted: June 4, 2007
• Study Start: June 15, 2006
• Primary Completion: October 30, 2020
• Study Completion: October 30, 2020
• Last Updated: November 3, 2020

Record last verified: 2020-10

Locations

CN (1)