CytotoxicityBRICNCT06343103
Study Evaluating Occupational Exposure to Antineoplastic Drugs
A study testing Workers exposed and Workers not exposed in people with Cytotoxicity, run by European Institute of Oncology at 5 sites in Italy.
Trial summary
The multicenter study involves comparing two groups (an exposed group and a control group). The exposed group is selected from workers who perform their activities in drug handling areas (DH) or units for antineoplastic preparation (UFA), while the control group involves the voluntary participation of non-exposed… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cytotoxicity
- What is being tested?
- Workers exposed and Workers not exposed
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 5 sitesItaly
- Study dates
- 2 Aug 2022to 31 Dec 2025
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old
- Capacity to understand and consent
- Personnel with an employment contract or similar arrangement
- Ability to comply with the procedures outlined in the protocol
- Signing of the informed consent
Who cannot join
- Age < 18 years old
- Any ongoing chemotherapy or radiation treatment for neoplasms of any kind
- Planned diagnostic exams involving radiation within three weeks following the signing of the Informed Consent
- Inability to comply with the procedures outlined in the protocol
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Italy5 sites, 5 recruiting
- Recruiting
IRCCS Ospedale Policlinico San Martino
Genova
Sabrina Beltramini
- Recruiting
European Institute of Oncology
Milan
Emanuela Omodeo Salè
- Recruiting
Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"
Naples
Piera Maiolino
- Recruiting
Istituto Oncologico Veneto Irccs
Padova
Nicoletta Rigamonti
- Recruiting
Fondazione Policlinico Universitario Campus Bio-Medico
Roma
Andrea Di Mattia
About this study
Official title: Multicentric Study to Evaluate Occupational Exposure to Antineoplastic Drugs Through Genotoxics Markers and Enviromental Monitoring
The multicenter study involves comparing two groups (an exposed group and a control group). The exposed group is selected from workers who perform their activities in drug handling areas (DH) or units for antineoplastic preparation (UFA), while the control group involves the voluntary participation of non-exposed workers (administrative staff).
The control group is selected based on the characteristics of the exposed group to ensure a homogeneous sample in terms of size and characteristics.
Read the detailed description
The study will be proposed to all workers exposed to cytotoxic agents who have an employment contract or similar arrangement and who are affiliated with the hospital facilities participating in the protocol. Participation of workers in the study is voluntary.
The control group will be recruited from administrative staff and/or individuals not exposed to chemotherapy who have an employment contract or similar arrangement and who are affiliated with the hospital facilities participating in the protocol.
A subject is considered enrolled after signing the informed consent and will be considered evaluable if:
They have completed the exposure diary (only for the exposed group). They have responded to the medical history questionnaire. They have undergone sampling of oral mucosa exfoliated cells and blood collection.
- Conditions
- Cytotoxicity
- Being tested
- Workers exposed, Workers not exposed
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Workers exposedOther
Workers exposed to cytotoxic agents
Workers not exposedOther
Workers not exposed to cytotoxic agents
| Study group | Role | What they receive |
|---|---|---|
| Workers exposed | Other | Workers exposed to cytotoxic agents Receives: Other: Workers exposed |
| Workers not exposed | Other | Workers not exposed to cytotoxic agents Receives: Other: Workers not exposed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the difference in micronuclei frequency
Correlation between the difference in micronuclei frequency ain the exposed and unexposed groups
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study start2 Aug 2022
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CytotoxicityStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Institute of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emanuela Omodeo Salè, Principal investigator, European Institute of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06343103
- Sponsor's protocol ID
- IEO 1735
- Acronym
- BRIC
- Status last verified
- Mar 2024
- First submitted
- 26 Mar 2024
- Last updated
- 2 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentric Study to Evaluate Occupational Exposure to Antineoplastic Drugs Through Genotoxics Markers and Enviromental Monitoring
- ClinicalTrials.gov ID
- NCT06343103
- Acronym / sponsor ID
- BRIC / IEO 1735
- Conditions
- Cytotoxicity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- European Institute of OncologyUniversity, hospital or other
- Study start
- 2 Aug 2022 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 2 Apr 2024 (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.
The multicenter study involves comparing two groups (an exposed group and a control group). The exposed group is selected from workers who perform their activities in drug handling areas (DH) or units for antineoplastic preparation (UFA), while the control group involves the voluntary participation of non-exposed workers (administrative staff).
The control group is selected based on the characteristics of the exposed group to ensure a homogeneous sample in terms of size and characteristics.
Detailed description
The study will be proposed to all workers exposed to cytotoxic agents who have an employment contract or similar arrangement and who are affiliated with the hospital facilities participating in the protocol. Participation of workers in the study is voluntary.
The control group will be recruited from administrative staff and/or individuals not exposed to chemotherapy who have an employment contract or similar arrangement and who are affiliated with the hospital facilities participating in the protocol.
A subject is considered enrolled after signing the informed consent and will be considered evaluable if:
They have completed the exposure diary (only for the exposed group). They have responded to the medical history questionnaire. They have undergone sampling of oral mucosa exfoliated cells and blood collection.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Workers exposed | Other | Other: Workers exposedWorkers exposed to cytotoxic agents |
| Workers not exposed | Other | Other: Workers not exposedWorkers not exposed to cytotoxic agents |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years old
- Capacity to understand and consent
- Personnel with an employment contract or similar arrangement
- Ability to comply with the procedures outlined in the protocol
- Signing of the informed consent
Key exclusion criteria (4 listed)
- Age < 18 years old
- Any ongoing chemotherapy or radiation treatment for neoplasms of any kind
- Planned diagnostic exams involving radiation within three weeks following the signing of the Informed Consent
- Inability to comply with the procedures outlined in the protocol
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 |
|---|---|---|
| Workers exposedWorkers exposed to cytotoxic agents | Other | Workers exposed |
| Workers not exposedWorkers not exposed to cytotoxic agents | Other | Workers not exposed |
Primary outcome
Evaluation of the difference in micronuclei frequency
Time frame: 1 year
Correlation between the difference in micronuclei frequency ain the exposed and unexposed groups
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
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Cytotoxicity
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.
Emanuela Omodeo Salè principal investigator
European Institute of Oncology
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Workers exposed and Workers not exposed in people with Cytotoxicity, run by European Institute of Oncology at 5 sites in Italy.
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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 2 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emanuela Omodeo Salè (+39 02 57489051, eomodeo@ieo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the difference in micronuclei frequency (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Apr 2024.