NCT04614129

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
734

participants targeted

Target at P75+ for not_applicable lung-cancer

Timeline
Completed

Started Mar 2021

Longer than P75 for not_applicable lung-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 28, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 3, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

March 2, 2021

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

November 24, 2025

Status Verified

November 1, 2025

Enrollment Period

4.7 years

First QC Date

October 28, 2020

Last Update Submit

November 20, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Nodule detection rate

    Frequency of nodule detection

    12 months

  • 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 Outcomes (2)

  • Interstitial lung disease detection rate

    12 months

  • Coronary artery calcification (CAC) ordinal scores

    12 months

Study Arms (1)

Low-Dose CT

EXPERIMENTAL

Low Dose CT Scan of the Chest

Diagnostic Test: Low Dose CT

Interventions

Low Dose CTDIAGNOSTIC_TEST

All participants will have a low dose chest CT either within one year of enrollment or after enrollment

Also known as: LDCT
Low-Dose CT

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Lung NeoplasmsLung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsRespiratory Tract Diseases

Study Officials

  • Erica T Warner, ScD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR
  • Lecia V Sequist, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

October 28, 2020

First Posted

November 3, 2020

Study Start

March 2, 2021

Primary Completion

November 1, 2025

Study Completion

November 1, 2025

Last Updated

November 24, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations