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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Workers exposed | Other | Workers exposed to cytotoxic agents |
|
| Workers not exposed | Other | Workers not exposed to cytotoxic agents |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Workers exposed | Other | Workers exposed to cytotoxic agents |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the difference in micronuclei frequency | Correlation between the difference in micronuclei frequency ain the exposed and unexposed groups | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Emanuela Omodeo Salè | Contact | +39 02 57489051 | eomodeo@ieo.it |
| Name | Affiliation | Role |
|---|---|---|
| Emanuela Omodeo Salè | European Institute of Oncology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Ospedale Policlinico San Martino | Recruiting | Genova | Italy |
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| Workers not exposed |
| Other |
Workers not exposed to cytotoxic agents |
|
| European Institute of Oncology | Recruiting | Milan | Italy |
|
| Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale" | Recruiting | Naples | Italy |
|
| Istituto Oncologico Veneto Irccs | Recruiting | Padova | Italy |
|
| Fondazione Policlinico Universitario Campus Bio-Medico | Recruiting | Roma | Italy |
|