- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05643014
Observational Study of Exposure to Environmental Toxicants Among Firefighters
March 10, 2026 updated by: Masonic Cancer Center, University of Minnesota
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
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
- Name: Joni Jensen
- Phone Number: 612-624-5178
- Email: jense010@umn.edu
Study Locations
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55455
- Recruiting
- Masonic Cancer Center
-
Contact:
- Stephen S Hecht
- Phone Number: 612-624-7604
- Email: hetcht002@umn.edu
-
Contact:
- Joni A Jensen
- Phone Number: +1 612-624-7604
- Email: jense010@umn.edu
-
-
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
Additional Relevant MeSH Terms
- Chemically-Induced Disorders
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Leukemia, Lymphoid
- Leukemia, B-Cell
- Poisoning
- Leukemia
- Leukemia, Lymphocytic, Chronic, B-Cell
- Investigative Techniques
- Clinical Laboratory Techniques
- Diagnostic Techniques and Procedures
- Diagnosis
- Specimen Handling
Other Study ID Numbers
- 2018NTLS135
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.
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