NCT01287169

Brief Summary

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. ...

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2011

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2011

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

January 29, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 1, 2011

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 4, 2012

Completed
Last Updated

July 17, 2019

Status Verified

December 4, 2012

First QC Date

January 29, 2011

Last Update Submit

July 16, 2019

Conditions

Keywords

Bisphenol A

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 20623271BACKGROUND
  • 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.

    PMID: 18197297BACKGROUND
  • 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.

    PMID: 16860916BACKGROUND

Study Officials

  • John Bucher, Ph.D.

    National Institute of Environmental Health Sciences (NIEHS)

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
NIH

Study Record Dates

First Submitted

January 29, 2011

First Posted

February 1, 2011

Study Start

January 10, 2011

Study Completion

December 4, 2012

Last Updated

July 17, 2019

Record last verified: 2012-12-04