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.
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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
500
Workers exposed to cytotoxic agents
Workers not exposed to cytotoxic agents
IRCCS Ospedale Policlinico San Martino
Genova, Italy
RECRUITINGEuropean Institute of Oncology
Milan, Italy
RECRUITINGIstituto Nazionale Tumori IRCCS "Fondazione G. Pascale"
Napoli, Italy
RECRUITINGEvaluation of the difference in micronuclei frequency
Correlation between the difference in micronuclei frequency ain the exposed and unexposed groups
Time frame: 1 year
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Istituto Oncologico Veneto Irccs
Padua, Italy
RECRUITINGFondazione Policlinico Universitario Campus Bio-Medico
Roma, Italy
RECRUITING