Observational Study of Exposure to Environmental Toxicants Among Firefighters

Sponsor

Masonic Cancer Center, University of Minnesota (Other)

Overall Status

Recruiting

CT.gov ID

NCT05643014

Collaborator

(none)

Enrollment

Location

46.9

Anticipated Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Observational, within subject study design with 1 pre and 2 post-fire exposure biomarker samples collected to assess exposure to toxicants from combustion emissions related to fighting a structural fire.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Other: Sample collection

Study Design

Study Type:

Observational

Anticipated Enrollment :

60 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Evaluate the Exposure to Toxicants Emitted During a Structural Fire Assessed by Urinary and Buccal Cell Biomarkers Found in Firefighters.

Actual Study Start Date :

Feb 1, 2020

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Firefighters over 18 years old This is a within subject, observational study of firefighters. This study will involve three sample collections including buccal cells and urine samples; one collection pre and two collections post-structural fire exposure.	Other: Sample collection This study will involve three sample collections including buccal cells and urine samples

Arm

Intervention/Treatment

Firefighters over 18 years old

This is a within subject, observational study of firefighters. This study will involve three sample collections including buccal cells and urine samples; one collection pre and two collections post-structural fire exposure.

Other: Sample collection

This study will involve three sample collections including buccal cells and urine samples

Outcome Measures

Primary Outcome Measures

Studying biomarker levels in firefighters pre and post fire call. [48 months]
The investigators will evaluate the differences between mean pre-exposure biomarker levels and post-exposure levels in urine and buccal samples collected within 24 hours post-exposure and 1-week post-exposure respectively using t-tests to test for statistical significance.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Firefighter (career or volunteer)
Over 18 years of age
Able to provide written voluntary consent

Exclusion Criteria:

Unwilling to provide a pre and post-exposure urine sample
Current cancer diagnosis
Tobacco use within the last 1 year (verified by urinary TNEs)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Masonic Cancer Center	Minneapolis	Minnesota	United States	55455

Sponsors and Collaborators

Masonic Cancer Center, University of Minnesota

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Masonic Cancer Center, University of Minnesota

ClinicalTrials.gov Identifier:

NCT05643014

Other Study ID Numbers:

2018NTLS135

First Posted:

Dec 8, 2022

Last Update Posted:

Dec 15, 2022

Last Verified:

Dec 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Masonic Cancer Center, University of Minnesota

Study Results

No Results Posted as of Dec 15, 2022