Nurses Internal Contamination by Antineoplastic Drugs. (CACIES)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03137641|
Recruitment Status : Recruiting
First Posted : May 3, 2017
Last Update Posted : October 12, 2018
|Condition or disease||Intervention/treatment|
|Antineoplastic Drugs Contamination Prevalence||Other: Nurses urine samples|
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.
|Study Type :||Observational|
|Estimated Enrollment :||225 participants|
|Official Title:||Assessment of Nurses Internal Contamination by Antineoplastic Drugs in Hospital Centers.|
|Actual Study Start Date :||October 16, 2017|
|Estimated Primary Completion Date :||October 16, 2018|
|Estimated Study Completion Date :||October 16, 2018|
Nurses in contact with chemotherapies
It is a nurses cohort, who administer chemotherapies or are in charge of patients treated by chemotherapie. Three urine samples are collected: first at the beginning of the workday, the second at the end of the workday, and the third, between four and ten hours after the end of the workday.
Other: Nurses urine samples
Collected urine samples from nurses in contact with antineoplastic drugs.
- Internal contamination by at least one antineoplastic drug. [ Time Frame: inclusion day ]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.
- Nurses contamination prevalence. [ Time Frame: inclusion day ]5 studied antineoplastic drugs concentration in urine samples.
- Socio-demographic factors. [ Time Frame: inclusion day ]Assessed by age, sexe, pregnancy, cigarette addiction questionnaire
- Practical work conditions. [ Time Frame: inclusion day ]Assessed by practical work conditions questionnaires.
- Patients management treated by 5 studied antineoplastic drugs. [ Time Frame: inclusion day ]Assessed by practical work conditions questionnaires.
- Safety equipment use. [ Time Frame: inclusion day ]Assessed by safety equipment questionnaire
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03137641
|Contact: VERDUN-ESQUER Catherine, Dr||5 56 79 61 65 ext +firstname.lastname@example.org|
|Contact: CANAL-RAFFIN Mireille, Dr||5 56 79 59 91 ext +email@example.com|
|Bordeaux, France, 33000|
|Contact: VERDUN-ESQUER Catherine, Dr 5 56 79 61 65 ext +33 firstname.lastname@example.org|
|Contact: CANAL-RAFFIN Mireille, Dr 5 56 79 59 91 ext +33 email@example.com|
|Sub-Investigator: PARTARRIEU Isabelle, Dr|
|Sub-Investigator: VIDEAU Nathalie, Dr|
|Sub-Investigator: LAPLACE Véronique, Dr|
|Principal Investigator: VERDUN-ESQUER Catherine, Dr|
|CHU de Toulouse||Recruiting|
|Toulouse, France, 31000|
|Contact: MARPINARD Monique, Dr Marpinard.Monique@iuct-oncopole.fr|
|Toulouse, France, 31000|
|Contact: MARPINARD Monique, Dr 5 31 15 50 30 ext +33 Marpinard.Monique@iuct-oncopole.fr|
|Contact: PORTES Eric Portes.Eric@iuct-oncopole.fr|
|Principal Investigator: MARPINARD Monique, Dr|
|Study Chair:||PARIENTE Antoine, Pr||Bordeaux PharmacoEpi (BPE)|