Lung Cancer Risk and Early Detection in Firefighters

Not Applicable

Recruiting

• Conditions: Lung Cancer; Lung Diseases
• Interventions: Diagnostic Test: Low Dose CT

• Registration Number: NCT04614129
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

This study will evaluate whether LDCT findings differ between firefighters and non-fighters, the relationship between occupational exposures and LDCT findings, and whether a proteomics assay can further risk-stratify screen-detected nodules among a study population of 850 current and retired firefighters and 1,120 matched controls.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-28
• Study First Submitted QC: 2020-10-28
• Study First Posted: 2020-11-03
• Study Start: 2021-03-02
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-21
• Last Update Posted: 2023-09-22
• Primary Completion: 2024-06-30
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 850

Inclusion Criteria

• 40-80 years of age or with 10 years of firefighting experience
• Current or retired firefighters
• No personal history of lung cancer
• Willing and able to receive LDCT screening at MGH or who have been screened via LDCT within the past year at MGH or another institution, and are willing to release their images to the study

Exclusion Criteria

• Any active cancer (undergoing treatment or diagnosed within the past 5 years)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Low-Dose CT	Low Dose CT	Low Dose CT Scan of the Chest

Primary Outcome Measures

Name	Time	Method
Nodule detection rate	12 months	Frequency of nodule detection
High-risk nodule detection rate	12 months	Frequency of high-risk nodule detection. High risk is defined as a Lung RADS of 3 or 4. Lung RADS categories are as follows: 0) Incomplete; 1) Negative; 2) Benign appearance or behavior; 3) Probably benign; 4) Suspicious

Secondary Outcome Measures

Name	Time	Method
Coronary artery calcification (CAC) ordinal scores	12 months	Frequency of high coronary artery calcification (CAC) ordinal scores. Possible scores range from 0 to 12 and high scores are defined as those greater than or equal to 10
Interstitial lung disease detection rate	12 months	Frequency of interstitial lung disease detection

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States