NCT06343103

Study Evaluating Occupational Exposure to Antineoplastic Drugs

Multicentric Study to Evaluate Occupational Exposure to Antineoplastic Drugs Through Genotoxics Markers and Enviromental Monitoring

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: European Institute of Oncology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Cytotoxicity

Interventions

Type	Name	Description
OTHER	Workers exposed	Workers exposed to cytotoxic agents
OTHER	Workers not exposed	Workers not exposed to cytotoxic agents

Timeline

• Start date: 2022-08-02
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2024-04-02
• Last updated: 2024-04-02

Locations

5 sites across 1 country: Italy