Studying Exposure to Trichloroethylene in Factory Workers in Guangdong Province, China - Full Text View

Sponsored by:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00353132

Purpose

RATIONALE: Exposure to trichloroethylene in the workplace may increase the risk of damaging white blood cells. Learning about the long-term effects of trichloroethylene exposure in factory workers in Guangdong Province, China, may help doctors learn more about the risks of this substance.

PURPOSE: This clinical trial is studying exposure to trichloroethylene in factory workers in Guangdong Province, China.

Condition	Intervention
Health Status Unknown	Genetic: cytogenetic analysis Genetic: molecular diagnostic method Other: laboratory biomarker analysis Other: questionnaire administration Procedure: study of high risk factors

MedlinePlus related topics: Occupational Health

Drug Information available for: Trichloroethylene

U.S. FDA Resources

Study Type:	Observational
Official Title:	A Cross-Sectional Study of Occupational Exposure to Trichloroethylene, Chromosomal Aberrations, and Related Biomarkers in Guangdong, China

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Association of trichloroethylene (TCE) exposure with chromosomal aberrations in peripheral blood lymphocytes

Secondary Outcome Measures:

Ability of TCE exposure to alter cytokine levels in plasma and change lymphocyte subset ratios
Intermediate and early biologic effect biomarkers of genotoxicity and immunotoxicity
Biomarkers of susceptibility

Estimated Enrollment:	120
Study Start Date:	June 2006

Detailed Description:

OBJECTIVES:

Primary

To determine if trichloroethylene (TCE) exposure increases chromosomal aberrations in peripheral blood lymphocytes in blood samples from factory workers in Guangdong Province, China.

Secondary

To determine if TCE exposure alters levels of key cytokines in plasma and changes lymphocyte subset ratios in the blood samples of these participants.
To determine intermediate and early biologic effect biomarkers of genotoxicity and immunotoxicity as well as biomarkers of susceptibility in the blood and urine samples of these participants.

OUTLINE: Participants wear small instruments at work that measure chemicals in the air for 1 or 2 days during the 2-week study period to assess the trichloroethylene exposure levels quantitatively. Participants who have been exposed to trichloroethylene also wear several small skin patches on 1 of the 2 days. Participants also complete a questionnaire related to other exposure information (e.g., work information, smoking and drinking habits, use of medicines, medical history, general health, hobbies, and exposure to radiation and other substances at home). Blood and urine samples are collected to assay a series of biomarkers of susceptibility and to determine intermediate and early biologic effects.

Eligibility

Ages Eligible for Study:	20 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Factory workers from 3 factories in Guangdong Province, China exposed to trichloroethylene (TCE) in the workplace while working for ≥ 1 year doing the same job in the same part of the manufacturing process and meeting the following criteria:
- Exposed to > 25 parts per million (ppm) TCE
- Exposed to 10 to < 25 ppm TCE
- Unexposed to TCE
No other exposure to other genotoxic, hematotoxic, or immunotoxic compounds in any workplace

PATIENT CHARACTERISTICS:

No history of cancer

PRIOR CONCURRENT THERAPY:

No prior chemotherapy with DNA-damaging or immunotoxic agents
No prior medical treatment with ionizing radiation

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00353132

Locations

China
Guangdong National Poison Control Center (NPCC)
Guangzhou, China

Sponsors and Collaborators

National Cancer Institute (NCI)

Investigators

Study Chair:

Qing Lan, MD

National Cancer Institute (NCI)

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

Mazzullo M, Bartoli S, Bonora B, Colacci A, Lattanzi G, Niero A, Silingardi P, Grilli S. In vivo and in vitro interaction of trichloroethylene with macromolecules from various organs of rat and mouse. Res Commun Chem Pathol Pharmacol. 1992 May;76(2):192-208.

Study ID Numbers:	CDR0000553301, NCI-06-C-N176, 999906176
Study First Received:	July 14, 2006
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00353132
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

health status unknown

Study placed in the following topic categories:

Chromosome Aberrations
Trichloroethylene

Additional relevant MeSH terms:

Anesthetics, Inhalation
Anesthetics, General
Therapeutic Uses
Physiological Effects of Drugs

Central Nervous System Depressants
Anesthetics
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2009