1. Study identification
EU PAS Register NumberEUPAS19729
Official titleNurses Internal Contamination by Antineoplastic Drugs
Study title acronymCACIES
Study typeObservational study
Brief description of the studyThe 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 Bordeaux teaching hospital, 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: Bordeaux teaching hospital 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.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)?
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicableNCT03137641
2. Research centres and Investigator details
Coordinating study entity
Organisation/affiliationUniversity of Bordeaux
Details of (Primary) lead investigator
Last name VERDUN-ESQUER
First name Catherine
Is this study being carried out with the collaboration of a research network?
Other centres where this study is being conducted
In total how many centres are involved in this Study?2
University Hospital of Bordeaux, Bordeaux, France
IUCT-Oncopole Toulouse, Toulouse, France
Countries in which this study is being conducted
3. Study timelines: initial administrative steps, progress reports and final report
Date when funding contract was signed01/02/201601/02/2016
Start date of data collection11/09/201716/10/2017
Start date of data analysis22/03/201917/07/2019
Date of interim report, if expected
Date of final study report30/11/201921/02/2020
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
EU funding scheme
Other2013-Hospital Clinical Research Programme100
5. Contact details for enquiries
Last name CANAL-RAFFIN
First name Mireille
Address line 1Laboratoire de Pharmacologie Clinique et de Toxicologie
Address line 2CHU de Bordeaux - Hôpital pellgrin
Address line 3Place Amélie Raba Léon
Phone number (incl. country code)0033556795991
Alternative phone number
Fax number (incl. country code)
Last name MOORE
First name Nicholas
Address line 1Université de Bordeaux-Service de Pharmacologie
Address line 2Bâtiment du Tondu - case 41
Address line 3146, Rue Léo Saignat
Phone number (incl. country code)0033557574675
Alternative phone number
Fax number (incl. country code)0033557574740