Clinical trial NCT03137641: Nurses Internal Contamination by Antineoplastic Drugs.
Official title: Assessment of Nurses Internal Contamination by Antineoplastic Drugs in Hospital Centers.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Antineoplastic Drugs Contamination Prevalence
Keywords: occupational exposure
antineoplastic drugs
biomonitoring
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
Collaborators: name: Bordeaux PharmacoEpi
First posted: 2017-05-03
Enrollment: 72
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Nurses working in anticancer unit.

Brief summary: CACIES is a descriptive study conducted in two hospital centers in France to assess nurses internal contamination by antineoplastic drugs.

Detailed description: The increase of cancer incidence contributes to a growing number of administered chemotherapies in care services. These antineoplastic drugs are not selective in their mechanisms of action, affecting noncancerous as well as cancerous cells, leading to several known side effects in treated patients. Health care professionals are increasingly exposed to antineoplastic drugs and can be potentially contaminated by these molecules. This is a key concern as part of assessment and occupational risk management in healthcare settings.

Occupational Health and Safety Department, in collaboration with Clinical and Toxicology Laboratory of university Hospital Bordeaux, developed analytical tools to assess this contamination in health care professional's urines, and the new acquisition of a high-sensitivity measurement equipment (LC-MS/MS) improved assays methods in terms of sensitivity and detection limits.

The main objective of the study is to assess internal contamination prevalence by the studied antineoplastic drugs (5-fluorouracil, cyclophosphamide, doxorubicin, ifosfamide, methotrexate) in nursing staff who administers these chemotherapies or is in charge of patients treated by these chemotherapies, in two French hospital centers: University Hospital Bordeaux and IUCT-Oncopole of Toulouse (Institut Universitaire du Cancer de Toulouse), including about fifteen services selected on their use of these specific chemotherapies.

The secondary objectives of the study are on the one hand, to describe for each of the five studied antineoplastic drugs the internal contamination prevalence in nursing staff, and concentration level associated to this contamination in contaminated nursing staff, and on the other hand, to identify contamination-associated factors in exposure characteristics and personal protective equipment use.

This is a descriptive, multicentre, transverse and prospective study.

Eligibility criteria: Inclusion Criteria:

* To be a nurse with Registered Nurse Licensure (IDE: Infirmier Diplômé d'Etat), practising in one of the selected services in Bordeaux teaching hospital or in IUCT-Oncopole,
* To have used at least one of the five antineoplastic drugs and/or to have cared one patient treated by one of the five antineoplastic drugs (5-fluorouracil, cyclophosphamide, doxorubicin, ifosfamide, methotrexate) in the workday of participation to the study (day with urine samples),
* To have accepted to participate to the study and signed the participation consent form.

Exclusion Criteria:

* To be a nursing student,
* To be treated or to have been treated in the year before the workday of study participation by one of the five antineoplastic drugs (5-fluorouracil, cyclophosphamide, doxorubicin, ifosfamide, methotrexate)
* To have at home, someone treated by one of the five antineoplastic drugs in the month before the workday of study participation

Primary outcomes:
measure: Internal contamination by at least one antineoplastic drug.
timeFrame: inclusion day
Secondary outcomes:
measure: Nurses contamination prevalence.
timeFrame: inclusion day
measure: Socio-demographic factors.
timeFrame: inclusion day
measure: Practical work conditions.
timeFrame: inclusion day
measure: Patients management treated by 5 studied antineoplastic drugs.
timeFrame: inclusion day
measure: Safety equipment use.
timeFrame: inclusion day
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Hôpital Pellegrin
city: Toulouse
country: France
facility: CHU de Toulouse
city: Toulouse
country: France
facility: IUCT-Oncopole
Study officials:
affiliation: Bordeaux PharmacoEpi (BPE)
name: PARIENTE Antoine, Pr
role: STUDY_CHAIR
References:
citation: Villa A, Molimard M, Bignon E, Martinez B, Rouyer M, Mathoulin-Pelissier S, Baldi I, Verdun-Esquer C, Canal-Raffin M. Study protocol for the assessment of nurses internal contamination by antineoplastic drugs in hospital centres: a cross-sectional multicentre descriptive study. BMJ Open. 2019 Nov 10;9(11):e033040. doi: 10.1136/bmjopen-2019-033040.