Nurses Internal Contamination by Antineoplastic Drugs (CACIES)

Study type

• Study topic:
  Other
• Study topic, other:
  Disease/Epidemiology study
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Population studied

• Short description of the study population:
  Nursing staff who administers these chemotherapies or is in charge of patients treated by 5-fluorouracil, cyclophosphamide, doxorubicin, ifosfamide, methotrexate chemotherapies, in two French hospital centers: Bordeaux teaching hospital and IUCT-Oncopole of Toulouse (Institut Universitaire du Cancer de Toulouse).
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
• Estimated number of subjects:
  71

Study design details

• Main study objective:
  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.
• Outcomes:
  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. -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…).
• Data analysis plan:
  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.