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Nurses Internal Contamination by Antineoplastic Drugs.

Assessment of Nurses Internal Contamination by Antineoplastic Drugs in Hospital Centers.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03137641
Acronym
CACIES
Enrollment
72
Registered
2017-05-03
Start date
2017-10-16
Completion date
2019-10-31
Last updated
2020-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antineoplastic Drugs Contamination Prevalence

Keywords

occupational exposure, antineoplastic drugs, biomonitoring

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.

Interventions

OTHERNurses urine samples

Collected urine samples from nurses in contact with antineoplastic drugs.

Sponsors

Bordeaux PharmacoEpi
CollaboratorOTHER
University Hospital, Bordeaux
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Internal contamination by at least one antineoplastic drug.inclusion dayPresence or absence of internal contamination by at least one antineoplastic drug of the five studied antineoplastic drugs (5-fluorouracil, cyclophosphamide, doxorubicin, ifosfamide, methotrexate) in at least one of the three urine samples collected by subject.

Secondary

MeasureTime frameDescription
Nurses contamination prevalence.inclusion day5 studied antineoplastic drugs concentration in urine samples.
Socio-demographic factors.inclusion dayAssessed by age, sexe, pregnancy, cigarette addiction questionnaire
Practical work conditions.inclusion dayAssessed by practical work conditions questionnaires.
Patients management treated by 5 studied antineoplastic drugs.inclusion dayAssessed by practical work conditions questionnaires.
Safety equipment use.inclusion dayAssessed by safety equipment questionnaire

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026