Study protocol for the assessment of nurses internal contamination by antineoplastic drugs in hospital centres: a cross-sectional multicentre descriptive study

Abstract

IntroductionAntineoplastic 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.Methods and analysisThis 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.Ethics and disseminationThe 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.Trial registration numberNCT03137641.

Real-world data on patients with metastatic non-small-cell lung cancer treated with checkpoint inhibitors in an Italian Teaching Hospital in 2015–2018

“…Patient eligibility criteria are defined with the goal to guarantee appropriateness and collect evidence to reduce uncertainty on drug’s efficacy. 28 Integration of registries (cancer and drug ones), hospital databases and extramural healthcare data is a goal to achieve. To reach it, significant efforts are done in Canada where cancer registry was linked to administrative databases to capture data for both inpatient (emergency room visits, hospital admissions, etc.)…”

A LC-MS/MS based methodology for the environmental monitoring of healthcare settings contaminated with antineoplastic agents

“…In 1979, Falck et al 8 first showed a significant increase in mutagenicity risk in urine samples collected from a staff of nurses assigned to the preparation and administration of AAs. Ever since, several studies have confirmed the occurrence of adverse health outcomes for workers exposed to AAs, including impact on pregnancy rate, 9–12 chronic 13,14 and acute effects. 15–17…”

The meta-analysis of sister chromatid exchange as a biomarker in healthcare workers with occupational exposure to antineoplastic drugs

“…[13] Numerous studies have shown that health care workers are at a high risk of being exposed to occupational ADs, and that the drugs can enter the body via direct skin contact, respiration, and ingestion via the gastrointestinal tract. [14][15][16][17] Moreover, the ingestion via the gastrointestinal tract should not be underestimated. [18] Exposure can occur at any time during drug preparation, administration, transfer, handling of spills, storage, waste, and patient excretion disposal.…”