Evaluating exposure to cancer treatment drugs among healthcare workers
Multicentric Study to Evaluate Occupational Exposure to Antineoplastic Drugs Through Genotoxics Markers and Enviromental Monitoring
This study is testing how being around certain cancer treatment drugs affects the health of hospital workers compared to those who don’t work with these drugs.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | European Institute of Oncology Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 5 sites (Genova and 4 other locations) |
| Trial ID | NCT06343103 on ClinicalTrials.gov |
What this trial studies
This multicenter study compares two groups of hospital workers: those exposed to antineoplastic drugs and a control group of non-exposed administrative staff. The exposed group will maintain an exposure diary, complete a medical history questionnaire, and undergo sampling of oral mucosa and blood collection. The study aims to assess the potential health impacts of occupational exposure to cytotoxic agents. Participation is voluntary and requires informed consent.
Who should consider this trial
Good fit: Ideal candidates are hospital workers aged 18 and older who handle antineoplastic drugs or are administrative staff not exposed to these agents.
Not a fit: Patients currently undergoing chemotherapy or radiation treatment for any neoplasm will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the health risks associated with occupational exposure to antineoplastic drugs, potentially leading to improved safety protocols.
How similar studies have performed: Other studies have explored occupational exposure to hazardous drugs, indicating a growing body of evidence, but this specific approach may provide novel insights.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Genova and 4 other locations
- IRCCS Ospedale Policlinico San Martino — Genova, Italy (Recruiting)
- European Institute of Oncology — Milan, Italy (Recruiting)
- Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale" — Napoli, Italy (Recruiting)
- Istituto Oncologico Veneto Irccs — Padova, Italy (Recruiting)
- Fondazione Policlinico Universitario Campus Bio-Medico — Roma, Italy (Recruiting)
Study contacts
- Principal investigator: Emanuela Omodeo Salè — European Institute of Oncology
- Study coordinator: Emanuela Omodeo Salè
- Email: eomodeo@ieo.it
- Phone: +39 02 57489051
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.