Clinical trial NCT06343103: Study Evaluating Occupational Exposure to Antineoplastic Drugs
Official title: Multicentric Study to Evaluate Occupational Exposure to Antineoplastic Drugs Through Genotoxics Markers and Enviromental Monitoring
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cytotoxicity
Lead sponsor: European Institute of Oncology
Sponsor class: OTHER
First posted: 2024-04-02
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Evaluation of the difference in micronuclei frequency
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Genova
country: Italy
facility: IRCCS Ospedale Policlinico San Martino
city: Milan
country: Italy
facility: European Institute of Oncology
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"
city: Padova
country: Italy
facility: Istituto Oncologico Veneto Irccs
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Campus Bio-Medico
Study officials:
affiliation: European Institute of Oncology
name: Emanuela Omodeo Salè
role: PRINCIPAL_INVESTIGATOR
References: