Antineoplastic Drugs Contamination PrevalenceCACIESNCT03137641
Nurses Internal Contamination by Antineoplastic Drugs.
An observational study of Antineoplastic Drugs Contamination Prevalence, run by University Hospital, Bordeaux at 3 sites in France.
Trial summary
CACIES is a descriptive study conducted in two hospital centers in France to assess nurses internal contamination by antineoplastic drugs. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Antineoplastic Drugs Contamination Prevalence
- What is being tested?
- Nurses urine samples
- How many people
- 72 participants
- Where
- 3 sitesFrance
- Study dates
- 16 Oct 2017to 31 Oct 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Nurses working in anticancer unit.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
France3 sites
Hôpital Pellegrin
Bordeaux, 33000
CHU de Toulouse
Toulouse, 31000
IUCT-Oncopole
Toulouse, 31000
About this study
Official title: Assessment of Nurses Internal Contamination by Antineoplastic Drugs in Hospital Centers.
CACIES is a descriptive study conducted in two hospital centers in France to assess nurses internal contamination by antineoplastic drugs.
Read the 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.
- Being tested
- Nurses urine samples
- Keywords
- occupational exposure, antineoplastic drugs, biomonitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurses urine samplesOther
Collected urine samples from nurses in contact with antineoplastic drugs.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Nurses urine samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: inclusion day
Secondary outcomes (5)
Nurses contamination prevalence.
5 studied antineoplastic drugs concentration in urine samples.
Measured: inclusion day
Socio-demographic factors.
Assessed by age, sexe, pregnancy, cigarette addiction questionnaire
Measured: inclusion day
Practical work conditions.
Assessed by practical work conditions questionnaires.
Measured: inclusion day
Patients management treated by 5 studied antineoplastic drugs.
Assessed by practical work conditions questionnaires.
Measured: inclusion day
Safety equipment use.
Assessed by safety equipment questionnaire
Measured: inclusion day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2017
- Study start16 Oct 2017
- Primary completion31 Oct 2019
- Study completion31 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Antineoplastic Drugs Contamination PrevalenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- Bordeaux PharmacoEpi
- Responsible party
- Sponsor
- Investigators
- PARIENTE Antoine, Pr, Study chair, Bordeaux PharmacoEpi (BPE)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03137641
- Sponsor's protocol ID
- CHUBX 2013/30
- Acronym
- CACIES
- Status last verified
- May 2020
- First submitted
- 28 Apr 2017
- Last updated
- 15 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31712349
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Nurses Internal Contamination by Antineoplastic Drugs in Hospital Centers.
- ClinicalTrials.gov ID
- NCT03137641
- Acronym / sponsor ID
- CACIES / CHUBX 2013/30
- Keywords
- occupational exposure, antineoplastic drugs, biomonitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- Bordeaux PharmacoEpi
- Study start
- 16 Oct 2017 (actual)
- Primary completion
- 31 Oct 2019 (actual)
- Study completion
- 31 Oct 2019 (actual)
- First posted
- 3 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
CACIES is a descriptive study conducted in two hospital centers in France to assess nurses internal contamination by antineoplastic drugs.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nurses in contact with chemotherapies | – | Other: Nurses urine samplesIt 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Nurses working in anticancer unit.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nurses urine samplesCollected urine samples from nurses in contact with antineoplastic drugs. | Other | Nurses in contact with chemotherapies |
Primary outcome
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.
5 secondary outcomes
Nurses contamination prevalence.
Time frame: inclusion day
Socio-demographic factors.
Time frame: inclusion day
Practical work conditions.
Time frame: inclusion day
Patients management treated by 5 studied antineoplastic drugs.
Time frame: inclusion day
Safety equipment use.
Time frame: inclusion day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2020.
- Derived from this study: PubMed 31712349Villa 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
PARIENTE Antoine, Pr study chair
Bordeaux PharmacoEpi (BPE)
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Antineoplastic Drugs Contamination Prevalence, run by University Hospital, Bordeaux at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Internal contamination by at least one antineoplastic drug. (time frame: inclusion day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03137641, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2020.