HealthyNCT05643014
Observational Study of Exposure to Environmental Toxicants Among Firefighters
An observational study of Healthy, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Sample collection
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2020to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Firefighter (career or volunteer)
- Over 18 years of age
- Able to provide written voluntary consent
Who cannot join
- Unwilling to provide a pre and post-exposure urine sample
- Current cancer diagnosis
- Tobacco use within the last 1 year (verified by urinary TNEs)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Masonic Cancer Center
Minneapolis, Minnesota, 55455
Stephen S Hecht, 612-624-7604, hetcht002@umn.edu
Joni A Jensen, +1 612-624-7604, jense010@umn.edu
About this study
Official title: 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.
- Conditions
- Healthy
- Being tested
- Sample collection
- Keywords
- PAH, 1-HOP, PheT, SPMA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sample collectionOther
This study will involve three sample collections including buccal cells and urine samples
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Sample collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Studying biomarker levels in firefighters pre and post fire call.
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.
Measured: 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2022
- Study start1 Feb 2020
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Masonic Cancer Center, University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05643014
- Sponsor's protocol ID
- 2018NTLS135
- Status last verified
- Mar 2026
- First submitted
- 30 Nov 2022
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate the Exposure to Toxicants Emitted During a Structural Fire Assessed by Urinary and Buccal Cell Biomarkers Found in Firefighters.
- ClinicalTrials.gov ID
- NCT05643014
- Acronym / sponsor ID
- 2018NTLS135
- Conditions
- Healthy
- Keywords
- PAH, 1-HOP, PheT, SPMA
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Masonic Cancer Center, University of MinnesotaUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 8 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Firefighters over 18 years old | – | Other: Sample collectionThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Firefighter (career or volunteer)
- Over 18 years of age
- Able to provide written voluntary consent
Key exclusion criteria (3 listed)
- Unwilling to provide a pre and post-exposure urine sample
- Current cancer diagnosis
- Tobacco use within the last 1 year (verified by urinary TNEs)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sample collectionThis study will involve three sample collections including buccal cells and urine samples | Other | Firefighters over 18 years old |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joni Jensen (612-624-5178, jense010@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Studying biomarker levels in firefighters pre and post fire call. (time frame: 48 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.