Nurses Internal Contamination by Antineoplastic Drugs.
CACIES
Assessment of Nurses Internal Contamination by Antineoplastic Drugs in Hospital Centers.
1 other identifier
observational
72
1 country
3
Brief Summary
CACIES is a descriptive study conducted in two hospital centers in France to assess nurses internal contamination by antineoplastic drugs.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2017
Typical duration for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 28, 2017
CompletedFirst Posted
Study publicly available on registry
May 3, 2017
CompletedStudy Start
First participant enrolled
October 16, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2019
CompletedMay 15, 2020
May 1, 2020
2 years
April 28, 2017
May 14, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Internal contamination by at least one antineoplastic drug.
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.
inclusion day
Secondary Outcomes (5)
Nurses contamination prevalence.
inclusion day
Socio-demographic factors.
inclusion day
Practical work conditions.
inclusion day
Patients management treated by 5 studied antineoplastic drugs.
inclusion day
Safety equipment use.
inclusion day
Study Arms (1)
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 : between 0 to 3h before the beginning of the workday second : between 0 to 2h after the end of the workday third : between 7 to 10h after the end of the workday
Interventions
Collected urine samples from nurses in contact with antineoplastic drugs.
Eligibility Criteria
Nurses working in anticancer unit.
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Bordeauxlead
- Bordeaux PharmacoEpicollaborator
Study Sites (3)
Hôpital Pellegrin
Bordeaux, 33000, France
CHU de Toulouse
Toulouse, 31000, France
IUCT-Oncopole
Toulouse, 31000, France
Related Publications (1)
Villa A, Molimard M, Bignon E, Martinez B, Rouyer M, Mathoulin-Pelissier S, Baldi I, Verdun-Esquer C, Canal-Raffin M. Study protocol for the assessment of nurses internal contamination by antineoplastic drugs in hospital centres: a cross-sectional multicentre descriptive study. BMJ Open. 2019 Nov 10;9(11):e033040. doi: 10.1136/bmjopen-2019-033040.
PMID: 31712349DERIVED
Biospecimen
Urine samples
Study Officials
- STUDY CHAIR
PARIENTE Antoine, Pr
Bordeaux PharmacoEpi (BPE)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 28, 2017
First Posted
May 3, 2017
Study Start
October 16, 2017
Primary Completion
October 31, 2019
Study Completion
October 31, 2019
Last Updated
May 15, 2020
Record last verified: 2020-05
Data Sharing
- IPD Sharing
- Will not share