Study Evaluating Occupational Exposure to Antineoplastic Drugs
BRIC
Multicentric Study to Evaluate Occupational Exposure to Antineoplastic Drugs Through Genotoxics Markers and Enviromental Monitoring
1 other identifier
interventional
500
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2022
Longer than P75 for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 2, 2022
CompletedFirst Submitted
Initial submission to the registry
March 26, 2024
CompletedFirst Posted
Study publicly available on registry
April 2, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedApril 2, 2024
March 1, 2024
3.4 years
March 26, 2024
March 26, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Evaluation of the difference in micronuclei frequency
Correlation between the difference in micronuclei frequency ain the exposed and unexposed groups
1 year
Study Arms (2)
Workers exposed
OTHERWorkers exposed to cytotoxic agents
Workers not exposed
OTHERWorkers not exposed to cytotoxic agents
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
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
Padua, Italy
Fondazione Policlinico Universitario Campus Bio-Medico
Roma, Italy
Study Officials
- PRINCIPAL INVESTIGATOR
Emanuela Omodeo Salè
European Institute of Oncology
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 26, 2024
First Posted
April 2, 2024
Study Start
August 2, 2022
Primary Completion
December 31, 2025
Study Completion
December 31, 2025
Last Updated
April 2, 2024
Record last verified: 2024-03