- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01287169
BPA Biomonitoring Study in Cashiers
We intend to conduct a pilot study designed to measure BPA levels before and after occupational exposure to thermal paper used in cash registers. We will recruit cashiers from a local commercial store that is currently still using BPA-laden thermal paper and plans to switch to BPA-free paper in the near future. The study uses a within-subject comparison design, using serum and urine samples to determine whether BPA is detectable in the study population at sufficient levels to measure differences in paired samples. Two phases of sample collection are proposed: Phase I - collecting paired samples on two separate occasions before the implementation of BPA-free thermal paper use in cash registers; and Phase II - collecting paired samples on two separate occasions after the implementation of this change in thermal paper.
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Study Overview
Status
Conditions
Detailed Description
Study Type
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
- INCLUSION CRITERIA:
- Male or female 18 years of age or older at the time of enrollment
- Employed as a cashier at the site location
- Anticipate continued employment at this business for the duration of both phases of the study
- Able to understand and provide written informed consent to participate in the study
- Have a minimum of 24 hours off from work before providing pre-shift samples
- Participants may be healthy or have preexisting conditions.
Field Site Inclusion Criteria:
- Have a minimum of 20 employed cashiers
- Use BPA-laden thermal paper and is planning to switch to BPA-free thermal paper
- Have a private area that the study nurse can use for enrollment and collection of biological samples
- Willing to collaborate with study team to conduct study on-site
EXCLUSION CRITERIA:
-There are no additional exclusion criteria
Study Plan
How is the study designed?
Design Details
Collaborators and Investigators
Investigators
- Principal Investigator: John Bucher, Ph.D., National Institute of Environmental Health Sciences (NIEHS)
Publications and helpful links
General Publications
- Biedermann S, Tschudin P, Grob K. Transfer of bisphenol A from thermal printer paper to the skin. Anal Bioanal Chem. 2010 Sep;398(1):571-6. doi: 10.1007/s00216-010-3936-9. Epub 2010 Jul 11.
- Calafat AM, Ye X, Wong LY, Reidy JA, Needham LL. Exposure of the U.S. population to bisphenol A and 4-tertiary-octylphenol: 2003-2004. Environ Health Perspect. 2008 Jan;116(1):39-44. doi: 10.1289/ehp.10753.
- Kang JH, Kondo F, Katayama Y. Human exposure to bisphenol A. Toxicology. 2006 Sep 21;226(2-3):79-89. doi: 10.1016/j.tox.2006.06.009. Epub 2006 Jun 16.
Study record dates
Study Major Dates
Study Start
Study Completion
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
- 999911074
- 11-E-N074
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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