Study Evaluating Occupational Exposure to Antineoplastic Drugs (BRIC)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cytotoxicity
• Intervention / Treatment: Other: Workers exposed; Other: Workers not exposed

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.

• Study Type: Interventional
• Enrollment (Estimated): 500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Emanuela Omodeo Salè; Phone Number: +39 02 57489051; Email: eomodeo@ieo.it

Study Locations

• Italy
  • Genova, Italy
    • Recruiting
    • IRCCS Ospedale Policlinico San Martino
    • Contact: Sabrina Beltramini
  • Milan, Italy
    • Recruiting
    • European Institute of Oncology
    • Contact: Emanuela Omodeo Salè
  • Napoli, Italy
    • Recruiting
    • Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"
    • Contact: Piera Maiolino
  • Padova, Italy
    • Recruiting
    • Istituto Oncologico Veneto IRCCS
    • Contact: Nicoletta Rigamonti
  • Roma, Italy
    • Recruiting
    • Fondazione Policlinico Universitario Campus Bio-medico
    • Contact: Andrea Di Mattia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Workers exposed; Workers exposed to cytotoxic agents	Other: Workers exposed; Workers exposed to cytotoxic agents
Other: Workers not exposed; Workers not exposed to cytotoxic agents	Other: Workers not exposed; Workers not exposed to cytotoxic agents

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the difference in micronuclei frequency	Correlation between the difference in micronuclei frequency ain the exposed and unexposed groups	1 year

Collaborators and Investigators

• Sponsor: European Institute of Oncology
• Investigators: Principal Investigator: Emanuela Omodeo Salè, European Institute of Oncology

Study record dates

Study Major Dates

• Study Start (Actual): August 2, 2022
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: March 26, 2024
• First Submitted That Met QC Criteria: March 26, 2024
• First Posted (Actual): April 2, 2024

Study Record Updates

• Last Update Posted (Actual): April 2, 2024
• Last Update Submitted That Met QC Criteria: March 26, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: IEO 1735

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No