Cytotoxicity
Conditions
Brief 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 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.
Interventions
OTHERWorkers exposed
Workers exposed to cytotoxic agents
OTHERWorkers not exposed
Workers not exposed to cytotoxic agents
Sponsors
European Institute of Oncology
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the difference in micronuclei frequency | 1 year | Correlation between the difference in micronuclei frequency ain the exposed and unexposed groups |
Countries
Italy
Contacts
Primary ContactEmanuela Omodeo Salè
Outcome results
None listed