Study protocol for the assessment of nurses internal contamination by antineoplastic drugs in hospital centres: a cross-sectional multicentre descriptive study.
Antineoplastic Agents
/ analysis
Biomarkers
/ urine
Cross-Sectional Studies
Cyclophosphamide
/ analysis
Doxorubicin
/ analysis
Environmental Monitoring
/ methods
Fluorouracil
/ analysis
France
Humans
Ifosfamide
/ analysis
Methotrexate
/ analysis
Multicenter Studies as Topic
Nursing Staff, Hospital
Observational Studies as Topic
Occupational Exposure
/ analysis
Oncology Nursing
Prospective Studies
Research Design
Self Report
antineoplastic drugs
biomonitoring
nurses
occupational & industrial medicine
occupational exposure
urine
Journal
BMJ open
ISSN: 2044-6055
Titre abrégé: BMJ Open
Pays: England
ID NLM: 101552874
Informations de publication
Date de publication:
10 11 2019
10 11 2019
Historique:
entrez:
13
11
2019
pubmed:
13
11
2019
medline:
2
12
2020
Statut:
epublish
Résumé
Antineoplastic drugs (AD) are potentially carcinogenic and/or reprotoxic molecules. Healthcare professionals are increasingly exposed to these drugs and can be potentially contaminated by them. Internal contamination of professionals is a key concern for occupational physicians in the assessment and management of occupational risks in healthcare settings. Objectives of this study are to report AD internal contamination rate in nursing staff and to identify factors associated with internal contamination. This trial will be conducted in two French hospital centres: University Hospital of Bordeaux and IUCT-Oncopole of Toulouse. The target population is nurses practicing in one of the fifteen selected care departments where at least one of the five studied AD is handled (5-fluorouracil, cyclophosphamide, doxorubicin, ifosfamide, methotrexate). The trial will be conducted with the following steps: (1) development of analytical methods to quantify AD urine biomarkers, (2) study of the workplace and organization around AD in each care department (transport and handling, professional practices, personal and collective protection equipments available) (3) development of a self-questionnaire detailing professional activities during the day of inclusion, (4) nurses inclusion (urine samples and self-questionnaire collection), (5) urine assays, (6) data analysis. The study protocol has been approved by the French Advisory Committee on the Treatment of Information in Health Research (CCTIRS) and by the French Data Protection Authority (CNIL). Following the opinion of the Regional Committee for the Protection of Persons, this study is outside the scope of the provisions governing biomedical research and routine care (n°2014/87). The results will be submitted to peer-reviewed journals and reported at suitable national and international meetings. NCT03137641.
Identifiants
pubmed: 31712349
pii: bmjopen-2019-033040
doi: 10.1136/bmjopen-2019-033040
pmc: PMC6858204
doi:
Substances chimiques
Antineoplastic Agents
0
Biomarkers
0
Doxorubicin
80168379AG
Cyclophosphamide
8N3DW7272P
Fluorouracil
U3P01618RT
Ifosfamide
UM20QQM95Y
Methotrexate
YL5FZ2Y5U1
Banques de données
ClinicalTrials.gov
['NCT03137641']
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
e033040Informations de copyright
© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
Déclaration de conflit d'intérêts
Competing interests: None declared.
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