- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06836414
Lung Cancer Screening CT for Firefighters
Early Cancer Detection in Firefighters With Low-Dose Chest CT: A Community-Based Approach
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
San Francisco, California, United States, 94143
- University of California, San Francisco
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
- Never smoker or quit more than 15 years ago.
- Able to understand study procedures and to comply with them for the entire length of the study.
- Ability of individual or legal guardian/representative to understand a written informed consent document, and the willingness to sign it.
- 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:
- Age 18+, may include deceased firefighters.
- A previous or current history of confirmed thoracic malignancy (except localized skin cancer, cancer in situ, or other localized cancers)
Exclusion Criteria:
Aim 1:
- Contraindication to any study-related procedure or assessment.
- 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.
- 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.
- Prior CT chest within 1 year.
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Firefighters (Lung Screening CT)
Participants will receive a single, low-dose, chest CT without contrast as indicated for lung cancer screening.
Participants will be followed up for at least 1 year following the scan and have ongoing medical record reviews.
|
Undergo CT for lung cancer screening
Other Names:
Participants will complete questionnaires on or before the day of the scan.
Medical history will be obtained in person and via medical record review
Other Names:
|
|
Other: Firefighters with Previously Diagnosed Malignancy
Participants with a history of cancer will have a medical record review as part of a case-control cohort.
|
Medical history will be obtained in person and via medical record review
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Proportion of participants with detected lung cancers (Aim 1)
Time Frame: Up to 10 years
|
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.
|
Up to 10 years
|
|
Proportion of participants with detected other cancers (Aim 1)
Time Frame: Up to 10 years
|
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.
|
Up to 10 years
|
|
Proportion of participants with occupational lung disease (Aim 1)
Time Frame: Up to 10 years
|
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.
|
Up to 10 years
|
|
Proportion of participants with diagnosed interstitial lung disease (Aim 1)
Time Frame: Up to 10 years
|
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.
|
Up to 10 years
|
|
Number of participants within of each Lung-RADS risk group
Time Frame: Up to 10 years
|
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.
|
Up to 10 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percentage of participants with incidental clinical findings
Time Frame: Up to 10 years
|
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.
|
Up to 10 years
|
|
Number of risk factors identified as associated with cancer development
Time Frame: Up to 10 years
|
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.
|
Up to 10 years
|
Collaborators and Investigators
Investigators
- Principal Investigator: Jae Ho Sohn, MD, MS, University of California, San Francisco
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Wounds and Injuries
- Pathologic Processes
- Neoplasms by Site
- Neoplasms
- Respiratory Tract Diseases
- Respiration Disorders
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Burns
- Burns, Inhalation
- Pathological Conditions, Signs and Symptoms
- Lung Diseases
- Lung Neoplasms
- Respiratory Aspiration
- Lung Diseases, Interstitial
- Smoke Inhalation Injury
- Health Care Quality, Access, and Evaluation
- Investigative Techniques
- Epidemiologic Methods
- Data Collection
- Health Care Evaluation Mechanisms
- Quality of Health Care
- Public Health
- Environment and Public Health
- Records
- Medical Records
- Surveys and Questionnaires
- Health Records, Personal
Other Study ID Numbers
- 24053
- NCI-2025-00336 (Registry Identifier: NCI Clinical Trials Reporting Program (CTRP))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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