Lung Cancer Risk and Early Detection in Firefighters

September 21, 2023 updated by: Erica T. Warner, ScD MPH, Massachusetts General Hospital
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

850

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nodule detection rate
Time Frame: 12 months
Frequency of nodule detection
12 months
High-risk nodule detection rate
Time Frame: 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
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Interstitial lung disease detection rate
Time Frame: 12 months
Frequency of interstitial lung disease detection
12 months
Coronary artery calcification (CAC) ordinal scores
Time Frame: 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
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 2, 2021

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

June 30, 2024

Study Registration Dates

First Submitted

October 28, 2020

First Submitted That Met QC Criteria

October 28, 2020

First Posted (Actual)

November 3, 2020

Study Record Updates

Last Update Posted (Actual)

September 22, 2023

Last Update Submitted That Met QC Criteria

September 21, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020P002693

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

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.

Clinical Trials on Lung Diseases

Clinical Trials on Low Dose CT

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uzbekistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe