Study Evaluating Occupational Exposure to Antineoplastic Drugs (BRIC)

European Institute of Oncology

Status: Enrolling

Conditions: Cytotoxicity

Treatments: Other: Workers not exposed; Other: Workers exposed

Study type: Interventional

Funder types: Other

Identifiers

NCT06343103

IEO 1735

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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500 participants in 2 patient groups

Workers exposed

Other group

Description:

Workers exposed to cytotoxic agents

Treatment:

Other: Workers exposed

Workers not exposed

Other group

Description:

Workers not exposed to cytotoxic agents

Treatment:

Other: Workers not exposed