Study Evaluating Occupational Exposure to Antineoplastic Drugs

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-02

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cytotoxicity

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Workers exposed

Workers exposed to cytotoxic agents

Group Type OTHER

Workers exposed

Intervention Type OTHER

Workers exposed to cytotoxic agents

Workers not exposed

Workers not exposed to cytotoxic agents

Group Type OTHER

Workers not exposed

Intervention Type OTHER

Workers not exposed to cytotoxic agents

Interventions

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Workers exposed

Workers exposed to cytotoxic agents

Intervention Type OTHER

Workers not exposed

Workers not exposed to cytotoxic agents

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes