Clinical Trials Directory

Trials / Completed

CompletedNCT03137641

Nurses Internal Contamination by Antineoplastic Drugs.

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

Status
Completed
Phase
Study type
Observational
Enrollment
72 (actual)
Sponsor
University Hospital, Bordeaux · Academic / Other
Sex
All
Age
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERNurses urine samplesCollected urine samples from nurses in contact with antineoplastic drugs.

Timeline

Start date
2017-10-16
Primary completion
2019-10-31
Completion
2019-10-31
First posted
2017-05-03
Last updated
2020-05-15

Locations

3 sites across 1 country: France

Source: ClinicalTrials.gov record NCT03137641. Inclusion in this directory is not an endorsement.