Lung Cancer Risk and Early Detection in Firefighters

Lung Cancer Clinical Trial

Official title:

Lung Cancer Risk and Early Detection in Firefighters

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04614129
• Other study ID #: 2020P002693
• Status: Recruiting
• Phase: N/A
• Start date: March 2, 2021
• Est. completion date: June 30, 2024

Study information

• Verified date: September 2023
• Source: Massachusetts General Hospital
• Contact: Study Administrator
• Phone: 6177249516
• Email: mghfhs[@]partners.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 850
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Lung Cancer
• Lung Diseases
• Lung Neoplasms

Intervention

Diagnostic Test:
• Low Dose CT
All participants will have a low dose chest CT either within one year of enrollment or after enrollment

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nodule detection rate	Frequency of nodule detection	12 months
Primary	High-risk nodule detection rate	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	12 months
Secondary	Interstitial lung disease detection rate	Frequency of interstitial lung disease detection	12 months
Secondary	Coronary artery calcification (CAC) ordinal scores	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	12 months