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
Department/Research grouppharmacoepidemiology
Organisation/affiliationUniversity of Bordeaux
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)
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
11. Scope of the study
What is the scope of the study?
Risk assessment
Primary scope : Risk assessment
12. Main objective(s)
What is the main objective of the study?
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.
Are there primary outcomes?Yes
Presence 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.
Are there secondary outcomes?Yes
-Contamination prevalence in nurses and concentration level for each of the 5 antineoplastic drugs ,
-Socio-demographic and occupational factors,
-Procedures for handling antineoplastic drugs and for taking care patients treated by these drugs,
-Personal protective equipment use (gloves…).
13. Study design
What is the design of the study?
Cohort study
14. Follow-up of patients
Will patients be followed up?Not applicable/no follow-up
15. Data analysis plan
Please provide a brief summary of the analysis method
The statistical analysis will include a descriptive analysis of included nurses (distribution according to service, age, sex, seniority, etc.…)
The analysis of the primary endpoint will be the proportion of contaminated subjects by at least one antineoplastic drug (among the five studied ones) in at least one of the three urine samples collected by subject
The analysis of the secondary endpoint will be based on:
- for each antineoplastic drug, the proportion of contaminated nurses,
- the description of the antineoplastic drugs handling procedures and of the management of patients,
- the description of personal protective equipments conditions of use,
- factors associated with the internal contamination of the nurses (multiple logistic regression model)
These results will be described overall and stratified by service.