Lung Cancer Risk and Early Detection in Firefighters

• Sponsor: Massachusetts General Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04614129
• Collaborator: (none)
• Enrollment: 2,100
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 25
• Patients Per Site Per Month: 84.1

Study Details

Study Description

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 560 current and retired firefighters and 1540 matched controls.

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer; Lung Diseases	Diagnostic Test: Low Dose CT	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 2100 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Screening
• Official Title: Lung Cancer Risk and Early Detection in Firefighters
• Actual Study Start Date: Mar 2, 2021
• Anticipated Primary Completion Date: Apr 1, 2023
• Anticipated Study Completion Date: Apr 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Low-Dose CT Low Dose CT Scan of the Chest	Diagnostic Test: Low Dose CT; All participants will have a low dose chest CT either within one year of enrollment or after enrollment; Other Names: LDCT

Outcome Measures

Primary Outcome Measures

1. Nodule detection rate [12 months]

   Frequency of nodule detection

2. 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

1. Interstitial lung disease detection rate [12 months]

   Frequency of interstitial lung disease detection

2. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• 40-80 years of age or with 10 years of firefighting experience

• Current or retired firefighters in the Boston/Greater Boston area

• 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts General Hospital	Boston	Massachusetts	United States	02114

Sponsors and Collaborators

• Massachusetts General Hospital

Investigators

• Principal Investigator: Erica T Warner, ScD, Massachusetts General Hospital
• Principal Investigator: Lecia V Sequist, MD, Massachusetts General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Erica T. Warner, Assistant Professor of Medicine, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT04614129
• Other Study ID Numbers: 2020P002693
• First Posted: Nov 3, 2020
• Last Update Posted: May 17, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Lung Neoplasms; Lung Diseases

Study Results

No Results Posted as of May 17, 2022