Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2025-12-29 @ 3:42 AM
Study NCT ID:
NCT01287169
Status:
WITHDRAWN
Last Update Posted:
2019-07-17
First Post:
2011-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BPA Biomonitoring Study in Cashiers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2011-01-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12-04', 'completionDateStruct': {'date': '2012-12-04'}, 'lastUpdateSubmitDate': '2019-07-16', 'studyFirstSubmitDate': '2011-01-29', 'studyFirstSubmitQcDate': '2011-01-29', 'lastUpdatePostDateStruct': {'date': '2019-07-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-02-01', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Bisphenol A'], 'conditions': ['Bisphenol A']}, 'referencesModule': {'references': [{'pmid': '20623271', 'type': 'BACKGROUND', 'citation': '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': '18197297', 'type': 'BACKGROUND', 'citation': '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': '16860916', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\n...', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '* INCLUSION CRITERIA:\n* Male or female 18 years of age or older at the time of enrollment\n* Employed as a cashier at the site location\n* Anticipate continued employment at this business for the duration of both phases of the study\n* Able to understand and provide written informed consent to participate in the study\n* Have a minimum of 24 hours off from work before providing pre-shift samples\n* Participants may be healthy or have preexisting conditions.\n\nField Site Inclusion Criteria:\n\n* Have a minimum of 20 employed cashiers\n* Use BPA-laden thermal paper and is planning to switch to BPA-free thermal paper\n* Have a private area that the study nurse can use for enrollment and collection of biological samples\n* Willing to collaborate with study team to conduct study on-site\n\nEXCLUSION CRITERIA:\n\n-There are no additional exclusion criteria'}, 'identificationModule': {'nctId': 'NCT01287169', 'briefTitle': 'BPA Biomonitoring Study in Cashiers', 'organization': {'class': 'NIH', 'fullName': 'National Institutes of Health Clinical Center (CC)'}, 'officialTitle': 'BPA Biomonitoring Study in Cashiers', 'orgStudyIdInfo': {'id': '999911074'}, 'secondaryIdInfos': [{'id': '11-E-N074'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'John Bucher, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Institute of Environmental Health Sciences (NIEHS)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Environmental Health Sciences (NIEHS)', 'class': 'NIH'}}}}