Multicentric Study to Evaluate Occupational Exposure to Antineoplastic Drugs Through Genotoxics Markers and Enviromental Monitoring
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 500
- 试验地点
- 6
- 主要终点
- Evaluation of the difference in micronuclei frequency
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Evaluation of the difference in micronuclei frequency
时间窗: 1 year
Correlation between the difference in micronuclei frequency ain the exposed and unexposed groups
次要结局
未报告次要终点