Study Evaluating Occupational Exposure to Antineoplastic Drugs

Last updated: March 26, 2024
Sponsor: European Institute of Oncology
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Workers not exposed

Workers exposed

Clinical Study ID

NCT06343103
IEO 1735
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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

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 signingof the Informed Consent
  • Inability to comply with the procedures outlined in the protocol

Study Design

Total Participants: 500
Treatment Group(s): 2
Primary Treatment: Workers not exposed
Phase:
Study Start date:
August 02, 2022
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • IRCCS Ospedale Policlinico San Martino

    Genova,
    Italy

    Active - Recruiting

  • European Institute of Oncology

    Milan,
    Italy

    Active - Recruiting

  • Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"

    Napoli,
    Italy

    Active - Recruiting

  • Istituto Oncologico Veneto Irccs

    Padova,
    Italy

    Active - Recruiting

  • Fondazione Policlinico Universitario Campus Bio-Medico

    Roma,
    Italy

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.