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Study Evaluating Occupational Exposure to Antineoplastic Drugs

Study Evaluating Occupational Exposure to Antineoplastic Drugs

Recruiting
18 years and older
All
Phase N/A

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Overview

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.

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

Study details
    Cytotoxicity

NCT06343103

European Institute of Oncology

12 April 2024

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FAQs

Learn more about clinical trials

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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