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| Name | Class |
|---|---|
| Bordeaux PharmacoEpi | OTHER |
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CACIES is a descriptive study conducted in two hospital centers in France to assess nurses internal contamination by antineoplastic drugs.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nurses urine samples | Other | Collected urine samples from nurses in contact with antineoplastic drugs. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Nurses contamination prevalence. | 5 studied antineoplastic drugs concentration in urine samples. | inclusion day |
| Socio-demographic factors. | Assessed by age, sexe, pregnancy, cigarette addiction questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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Nurses working in anticancer unit.
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| Name | Affiliation | Role |
|---|---|---|
| PARIENTE Antoine, Pr | Bordeaux PharmacoEpi (BPE) | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Pellegrin | Bordeaux | 33000 | France | |||
| CHU de Toulouse |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31712349 | Derived | 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. |
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Urine samples
| inclusion day |
| Practical work conditions. | Assessed by practical work conditions questionnaires. | inclusion day |
| Patients management treated by 5 studied antineoplastic drugs. | Assessed by practical work conditions questionnaires. | inclusion day |
| Safety equipment use. | Assessed by safety equipment questionnaire | inclusion day |
| Toulouse |
| 31000 |
| France |
| IUCT-Oncopole | Toulouse | 31000 | France |