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Trial record 12 of 13 for:    Recruiting, Not yet recruiting, Available Studies | "Occupational Exposure"

Nurses Internal Contamination by Antineoplastic Drugs. (CACIES)

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ClinicalTrials.gov Identifier: NCT03137641
Recruitment Status : Recruiting
First Posted : May 3, 2017
Last Update Posted : October 12, 2018
Sponsor:
Collaborator:
Bordeaux PharmacoEpi
Information provided by (Responsible Party):
University Hospital, Bordeaux

Brief Summary:
CACIES is a descriptive study conducted in two hospital centers in France to assess nurses internal contamination by antineoplastic drugs.

Condition or disease Intervention/treatment
Antineoplastic Drugs Contamination Prevalence Other: Nurses urine samples

Detailed 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 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
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Nurses contamination prevalence. [ Time Frame: inclusion day ]
    5 studied antineoplastic drugs concentration in urine samples.

  2. Socio-demographic factors. [ Time Frame: inclusion day ]
    Assessed by age, sexe, pregnancy, cigarette addiction questionnaire

  3. Practical work conditions. [ Time Frame: inclusion day ]
    Assessed by practical work conditions questionnaires.

  4. Patients management treated by 5 studied antineoplastic drugs. [ Time Frame: inclusion day ]
    Assessed by practical work conditions questionnaires.

  5. Safety equipment use. [ Time Frame: inclusion day ]
    Assessed by safety equipment questionnaire


Biospecimen Retention:   Samples Without DNA
Urine samples


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Nurses working in anticancer unit.
Criteria

Inclusion Criteria:

  • To be a nurse with Registered Nurse Licensure (IDE: Infirmier Diplômé d'Etat), practising in one of the selected services in Bordeaux teaching hospital or in IUCT-Oncopole,
  • To have used at least one of the five antineoplastic drugs and/or to have cared one patient treated by one of the five antineoplastic drugs (5-fluorouracil, cyclophosphamide, doxorubicin, ifosfamide, methotrexate) in the workday of participation to the study (day with urine samples),
  • To have accepted to participate to the study and signed the participation consent form.

Exclusion Criteria:

  • To be a nursing student,
  • To be treated or to have been treated in the year before the workday of study participation by one of the five antineoplastic drugs (5-fluorouracil, cyclophosphamide, doxorubicin, ifosfamide, methotrexate)
  • To have at home, someone treated by one of the five antineoplastic drugs in the month before the workday of study participation

Information from the National Library of Medicine

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


Contacts
Contact: VERDUN-ESQUER Catherine, Dr 5 56 79 61 65 ext +33 catherine.verdun-esquer@chu-bordeaux.fr
Contact: CANAL-RAFFIN Mireille, Dr 5 56 79 59 91 ext +33 mireille.raffin@chu-bordeaux.fr

Locations
France
Hôpital Pellegrin Recruiting
Bordeaux, France, 33000
Contact: VERDUN-ESQUER Catherine, Dr    5 56 79 61 65 ext +33    catherine.verdun-esquer@chu-bordeaux.fr   
Contact: CANAL-RAFFIN Mireille, Dr    5 56 79 59 91 ext +33    mireille.raffin@chu-bordeaux.fr   
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   
IUCT-Oncopole Recruiting
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         
Sponsors and Collaborators
University Hospital, Bordeaux
Bordeaux PharmacoEpi
Investigators
Study Chair: PARIENTE Antoine, Pr Bordeaux PharmacoEpi (BPE)

Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT03137641     History of Changes
Other Study ID Numbers: CHUBX 2013/30
First Posted: May 3, 2017    Key Record Dates
Last Update Posted: October 12, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Bordeaux:
occupational exposure
antineoplastic drugs
biomonitoring

Additional relevant MeSH terms:
Antineoplastic Agents