Status: Finalised First registered on: 31/07/2017
Last updated on: 03/02/2022
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)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicableNCT03137641 https://clinicaltrials.gov/ct2/show/NCT03137641?term=CACIES&rank=1
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsBordeaux PharmacoEpi
Department/Research grouppharmacoepidemiology
Organisation/affiliationUniversity of Bordeaux
Website/Homepagewww.pharmacoepi.eu
Details of (Primary) lead investigator
Title Dr
Last name VERDUN-ESQUER
First name Catherine
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Multiple centres

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
National study

France
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
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
Pharmaceutical companies
Charities
Government body
Research councils
EU funding scheme
Other2013-Hospital Clinical Research Programme100
5. Contact details for enquiries
Scientific Enquiries
Title Dr
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 
CityBordeaux 
Postcode33076 
CountryFrance
Phone number (incl. country code)0033556795991 
Alternative phone number 
Fax number (incl. country code) 
Email address mireille.raffin@chu-bordeaux.fr
Public Enquiries
Title Professor 
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 
CityBordeaux 
Postcode33076 
CountryFrance 
Phone number (incl. country code)0033557574675 
Alternative phone number 
Fax number (incl. country code)0033557574740 
Email address nicholas.moore@u-bordeaux.fr 
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