Ignite Creation Date:
2024-05-05 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00481611
Status:
COMPLETED
Last Update Posted:
2020-11-03
First Post:
2007-06-01
Brief Title:
Cancer Markers Associated With Occupational Exposure to Trichloroethylene
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Cross-Sectional Study of Occupational Exposure to Trichloroethylene Chromosomal Aberrations and Related Biomarkers in Guangdong China
Status:
COMPLETED
Status Verified Date:
2020-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
Trichloroethylene TCE is an industrial solvent used in degreasing dry cleaning and numerous other medical and industrial processes It is a ubiquitous environmental contaminant of drinking water and is present in many EPA Superfund sites TCE is a rodent carcinogen but its carcinogenicity in humans is unclear There is some evidence for an elevation in liver and kidney cancers and somewhat more convincing evidence of an association with non-Hodgkin lymphoma NHL in epidemiological studies of occupationally exposed cohorts Overall the carcinogenicity of TCE and its regulation is a matter of continuing debate despite an extensive database of in vitro and in vivo animal studies and several cohort and case-control studies IARC categorizes TCE as a probable human carcinogen In order to address questions about TCEs potential carcinogenicity and mechanism of action in humans we propose to conduct a cross-sectional study of early biologic effect biomarkers of genotoxicity and immunotoxicity in 45 workers exposed to greater than 25 ppm TCE 30 workers exposed to 10-25 ppm TCE and 45 unexposed controls in Guangdong Province China We will assess TCE exposure level quantitatively collect other exposure information through a questionnaire collect biological samples and assay a series of biomarkers of susceptibility intermediate and early biologic effects Our primary goal is to determine if TCE exposure increases chromosomal aberrations in peripheral lymphocytes with a secondary goal of determining if TCE alters levels of key cytokines in plasma and changes lymphocyte subset ratios In addition our collaborators at UC Berkeley will apply a new generation of cytogenetic and molecular techniques to study TCEs ability to cause specific types of chromosomal aberrations that have been associated with NHL and related hematological malignancies as well as the impact of TCE on mRNA expression and the proteome The work will compliment previous and ongoing OEEB studies of populations exposed to TCE and has the potential to make an important contribution to what little is known about the early biologic effects of TCE in humans
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 06-C-N176 | None | None | None |