Observational Study of Exposure to Environmental Toxicants Among Firefighters

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Recruiting
        • Masonic Cancer Center
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Firefighters who are exposed to fires containing carcinogens will join this study. Three sample collections will be taken to measure the biomarkers; pre-exposure, 24h post-exposure and 1 week post-exposure.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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.
This study will involve three sample collections including buccal cells and urine samples

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Studying biomarker levels in firefighters pre and post fire call.
Time Frame: 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.
48 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2020

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

November 30, 2022

First Submitted That Met QC Criteria

November 30, 2022

First Posted (Actual)

December 8, 2022

Study Record Updates

Last Update Posted (Actual)

March 12, 2026

Last Update Submitted That Met QC Criteria

March 10, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All data will be de-identified and transferred through a secure, password-protected website that is only available to the investigators. All identifying information will be in a locked in a secure place and accessible only to relevant study staff.

IPD Sharing Supporting Information Type

  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy

Clinical Trials on Sample collection

Subscribe