Study Evaluating Occupational Exposure to Antineoplastic Drugs

Cytotoxicity Clinical Trial

— BRIC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06343103
• Other study ID #: IEO 1735
• Status: Recruiting
• Phase: N/A
• Start date: August 2, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2024
• Source: European Institute of Oncology
• Contact: Emanuela Omodeo Salè
• Phone: +39 02 57489051
• Email: eomodeo[@]ieo.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cytotoxicity

Intervention

Other:
• Workers exposed
Workers exposed to cytotoxic agents
• Workers not exposed
Workers not exposed to cytotoxic agents

Locations

Country	Name	City	State
Italy	IRCCS Ospedale Policlinico San Martino	Genova
Italy	European Institute of Oncology	Milan
Italy	Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"	Napoli
Italy	Istituto Oncologico Veneto Irccs	Padova
Italy	Fondazione Policlinico Universitario Campus Bio-Medico	Roma

Sponsors (1)

Lead Sponsor	Collaborator
European Institute of Oncology

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the difference in micronuclei frequency	Correlation between the difference in micronuclei frequency ain the exposed and unexposed groups	1 year