NCT05643014

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
20mo left

Started Feb 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress79%
Feb 2020Dec 2027

Study Start

First participant enrolled

February 1, 2020

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

November 30, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 8, 2022

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

March 12, 2026

Status Verified

March 1, 2026

Enrollment Period

6.9 years

First QC Date

November 30, 2022

Last Update Submit

March 10, 2026

Conditions

Keywords

PAH1-HOPPheTSPMA

Outcome Measures

Primary Outcomes (1)

  • 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.

    48 months

Study Arms (1)

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

Interventions

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

Firefighters over 18 years old

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Masonic Cancer Center

Minneapolis, Minnesota, 55455, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Participants will provide urine and buccal cell samples.

MeSH Terms

Interventions

Specimen Handling

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2022

First Posted

December 8, 2022

Study Start

February 1, 2020

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Last Updated

March 12, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
CSR, ANALYTIC CODE

Locations