CompletedNot Applicable

Cancer Markers Associated With Occupational Exposure to Trichloroethylene

China125 participantsStarted 2006-06-15

Plain-language 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.

Who can participate

Age range

18 Years – 50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

* 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Hematotoxicity change

Timeframe: 2006-2034

Immune function

Timeframe: 2006-2034

Trial details

NCT IDNCT00481611

SponsorNational Cancer Institute (NCI)

Sponsor typeNIH

Study typeOBSERVATIONAL

Primary completion2020-10-30

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