Bisphenol ANCT01287169
BPA Biomonitoring Study in Cashiers
An observational study of Bisphenol A, run by National Institute of Environmental Health Sciences (NIEHS).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Bisphenol A
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 10 Jan 2011to 4 Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 11Show fewer
- 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
Who cannot join
- -There are no additional exclusion criteria
About this study
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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Read the detailed description
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.
- Conditions
- Bisphenol A
- Keywords
- Bisphenol A
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2011 (estimated)
- Study start10 Jan 2011
- Study completion4 Dec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Bisphenol AStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)
- Sponsor type
- US National Institutes of Health
- Investigators
- John Bucher, Ph.D., Principal investigator, National Institute of Environmental Health Sciences (NIEHS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01287169
- Sponsor's protocol ID
- 999911074
- Other IDs
- 11-E-N074
- Status last verified
- 4 Dec 2012
- First submitted
- 29 Jan 2011
- Last updated
- 17 Jul 2019
- Results posted
- No
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.
PubMed 20623271Calafat 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.
PubMed 18197297Kang 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.
PubMed 16860916
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BPA Biomonitoring Study in Cashiers
- ClinicalTrials.gov ID
- NCT01287169
- Acronym / sponsor ID
- 999911074
- Conditions
- Bisphenol A
- Keywords
- Bisphenol A
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)US National Institutes of Health
- Study start
- 10 Jan 2011
- Study completion
- 4 Dec 2012
- First posted
- 1 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
...
Detailed description
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.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (1 listed)
- -There are no additional exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2019.
- Background: PubMed 20623271Biedermann 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.
- Background: PubMed 18197297Calafat 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.
- Background: PubMed 16860916Kang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Bucher, Ph.D. principal investigator
National Institute of Environmental Health Sciences (NIEHS)
Questions about this trial
What is this clinical trial studying?
An observational study of Bisphenol A, run by National Institute of Environmental Health Sciences (NIEHS).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01287169, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2019.