Clinical trial NCT06836414: Lung Cancer Screening CT for Firefighters
Official title: Early Cancer Detection in Firefighters With Low-Dose Chest CT: A Community-Based Approach
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Smoke Inhalation
Exposure, Inhalation
Exposure to Pollution
Exposure Occupational
Lung Diseases
Lung Cancer
Lung Diseases, Interstitial
Occupational Exposure
Occupational Lung Disease
Interstitial Lung Disease
Keywords: Population research
Cancer Screening
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Hayward Firefighters Local 1909 of the International Association of Firefighters
First posted: 2025-02-20
Enrollment: 1200
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Firefighters are at increased risk for cancer due to exposure to carcinogenic substances. Current lung cancer screening guidelines are predominantly based on smoking history and do not take into account high risk occupational exposures such as firefighting. This study aims to provide chest computed tomography (CT) scans to firefighters to determine the prevalence of lung cancer, other cancers detectable on CT chest, and lung diseases associated with increased cancer risk.

Detailed description: This is a single-group prospective interventional study and a community-based participatory project led by University of California, San Francisco and in close collaboration with the firefighter community in California.

PRIMARY OBJECTIVE:

I. Determine the prevalence of lung cancer, other cancers and cancer risk factors detectable on chest Computerized Tomography (CT) (Aim 1).

II. Identify imaging and non-imaging predictors of lung cancer and other cancers detectable on chest CT.

SECONDARY OBJECTIVE:

I. Determine the prevalence of incidental findings on chest CT (Aim 1).

II. Determine the risk factors for cancer development in firefighters (Aim 2).

EXPLORATORY OBJECTIVES:

I. Long term follow-up to determine the incidence of lung cancer and other cancers among firefighters.

II. Develop a firefighter cancer imaging registry.

OUTLINE:

Participants will be administered a single, low dose chest CT to included participants and collect comprehensive demographic, clinical, and occupational data. Participants will be followed up at 1-2 months, for at least 1 year and up to 10 years to collect any follow-up imaging and biopsy results, if applicable.

Eligibility criteria: Inclusion Criteria:

1. Age 35 years or greater. If the participant is above the age of 80, participants must be otherwise healthy and well-fit to undergo treatment if lung cancer were to be discovered.
2. Never smoker or quit more than 15 years ago.
3. Able to understand study procedures and to comply with them for the entire length of the study.
4. Ability of individual or legal guardian/representative to understand a written informed consent document, and the willingness to sign it.
5. Length in profession for 10 or more years. This includes both volunteer firefighting and professional firefighting, self-attested as verifiable by professional records.

Additional cases for Aim 2:

1. Age 18+, may include deceased firefighters.
2. A previous or current history of confirmed thoracic malignancy (except localized skin cancer, cancer in situ, or other localized cancers)

Exclusion Criteria:

* Aim 1:

  1. Contraindication to any study-related procedure or assessment.
  2. Personal history of malignancy within 5 years (except localized skin cancer, cancer in situ, or localized cancers that are definitively treated and are unlikely to recur) or lung cancer at any time.
  3. Participants will be assessed for active pregnancy per standard procedure for clinical lung cancer screening CT at University of California, San Francisco which includes asking the participants directly along with documentation of whether the negative pregnancy was self-reported or confirmed with a urine pregnancy test.
  4. Prior CT chest within 1 year.
  5. Symptoms highly suggestive of lung cancer, including unexplained weight loss of over 30 pounds (lbs) within the past 12 months or unexplained hemoptysis.
* Aim 2:

No exclusion criteria

Primary outcomes:
measure: Proportion of participants with detected lung cancers (Aim 1)
timeFrame: Up to 10 years
measure: Proportion of participants with detected other cancers (Aim 1)
timeFrame: Up to 10 years
measure: Proportion of participants with occupational lung disease (Aim 1)
timeFrame: Up to 10 years
measure: Proportion of participants with diagnosed interstitial lung disease (Aim 1)
timeFrame: Up to 10 years
measure: Number of participants within of each Lung-RADS risk group
timeFrame: Up to 10 years
Secondary outcomes:
measure: Percentage of participants with incidental clinical findings
timeFrame: Up to 10 years
measure: Number of risk factors identified as associated with cancer development
timeFrame: Up to 10 years
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Jae Ho Sohn, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: