Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06343103
Status:
RECRUITING
Last Update Posted:
2024-04-02
First Post:
2024-03-26
Brief Title:
Study Evaluating Occupational Exposure to Antineoplastic Drugs
Sponsor:
European Institute of Oncology
Organization:
European Institute of Oncology
Study Overview
Official Title:
Multicentric Study to Evaluate Occupational Exposure to Antineoplastic Drugs Through Genotoxics Markers and Enviromental Monitoring
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BRIC
Brief 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
The control group is selected based on the characteristics of the exposed group to ensure a homogeneous sample in terms of size and characteristics
Detailed 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 andor 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
The control group will be recruited from administrative staff andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None