Nurses Internal Contamination by Antineoplastic Drugs (CACIES)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/45549
• EU PAS number:
  EUPAS19729
• Study ID:
  45549
• Official title and acronym:
  Nurses Internal Contamination by Antineoplastic Drugs (CACIES)
• DARWIN EU® study:
  No
• Study countries:
  France
• Study 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 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.
• Study status:
  Finalised

Research institution and networks

Institutions

Bordeaux PharmacoEpi, University of Bordeaux

France

University Hospital of Bordeaux Bordeaux, France, IUCT-Oncopole Toulouse Toulouse, France

Study timelines

Date when funding contract was signed

Planned: 01/02/2016

Actual: 01/02/2016

Study start date

Planned: 11/09/2017

Actual: 16/10/2017

Data analysis start date

Planned: 22/03/2019

Actual: 17/07/2019

Date of final study report

Planned: 30/11/2019

Actual: 21/02/2020

Sources of funding

Other

More details on funding

2013-Hospital Clinical Research Programme

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable

Other study registration identification numbers and links

NCT03137641https://clinicaltrials.gov/ct2/show/NCT03137641?term=CACIES&rank=1