Lung Cancer Screening CT for Firefighters

N/ANot Yet RecruitingNCT06836414

University of California, San Francisco1,200 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

1,200

Eligibility

Sex: ALLMin age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Proportion of participants with detected lung cancers (Aim 1)

The proportion of participants with detected lung cancers will be determined by the frequency of image findings that indicate lung cancer, and an ultimate clinical diagnosis associated with the imaging finding.

Time frame: Up to 10 years

Proportion of participants with detected other cancers (Aim 1)

The proportion of participants with detected cancers, other than lung, will be determined by the frequency of image findings that indicate other cancer, and an ultimate clinical diagnosis associated with the imaging finding.

Time frame: Up to 10 years

Proportion of participants with occupational lung disease (Aim 1)

Occupational or work-related lung diseases are lung conditions that have been caused or made worse by long-term exposure to certain irritants in the workplace. The proportion of participants with occupational lung disease will be determined by the frequency of image findings that indicate occupationally associated lung disease, and an ultimate clinical diagnosis associated with the imaging finding.

Time frame: Up to 10 years

Proportion of participants with diagnosed interstitial lung disease (Aim 1)

Interstitial Lung Disease (ILD) is a group of diseases that irritate, inflame, or scar the lungs and supporting air sacs. The proportion of participants with diagnosed interstitial lung disease will be determined by the frequency of image findings that indicate ILD, and an ultimate clinical diagnosis associated with the imaging finding.

Time frame: Up to 10 years

Number of participants within of each Lung-RADS risk group

The Lung CT Screening Reporting and Data System (Lung-RADS) is a measure developed by the American College of Radiologists to standardize the reporting and management of screen-detected pulmonary nodules. Nodules are categorized as 0=Incomplete, 1=Negative, 2=Benign Appearance or Behavior, 3=Probably Benign, or 4A /4B /4X = Suspicious with an additional modifier of S=Other or C=Prior Lung Cancer to be added to the 4 category codes as needed. The frequency of participants within each Lung-RADS risk group as determined by imaging procedures will be reported.

Time frame: Up to 10 years

Secondary Outcomes

Percentage of participants with incidental clinical findings

The percentage of participants with incidental findings be determined by the frequency of image findings that indicate presence of possible coronary calcium, aortic aneurysm, thyroid nodules, liver pathology and osseous pathology and an ultimate clinical diagnosis associated with the imaging finding.

Time frame: Up to 10 years

Number of risk factors identified as associated with cancer development

The number of not-yet identified risk factors that are determined to be significantly associated with the development of thoracic cancers will be determined using logistic regression methods.

Time frame: Up to 10 years

Lung Cancer Screening CT for Firefighters

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts