Back to resultsLung Cancer Risk and Early Detection in Firefighters
Primary Purpose
Lung Cancer, Lung Diseases
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Low Dose CT
Sponsored by
About this trial
This is an interventional screening trial for Lung Cancer
Eligibility Criteria
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)
Sites / Locations
- Massachusetts General HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Low-Dose CT
Arm Description
Low Dose CT Scan of the Chest
Outcomes
Primary Outcome Measures
Nodule detection rate
Frequency of nodule detection
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
Secondary Outcome Measures
Interstitial lung disease detection rate
Frequency of interstitial lung disease detection
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
Full Information
NCT ID
NCT04614129
First Posted
October 28, 2020
Last Updated
September 21, 2023
Sponsor
Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04614129
Brief Title
Lung Cancer Risk and Early Detection in Firefighters
Official Title
Lung Cancer Risk and Early Detection in Firefighters
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 2, 2021 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
4. Oversight
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
Data Monitoring Committee
No
5. 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 850 current and retired firefighters and 1,120 matched controls.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Lung Diseases
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
850 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Low-Dose CT
Arm Type
Experimental
Arm Description
Low Dose CT Scan of the Chest
Intervention Type
Diagnostic Test
Intervention Name(s)
Low Dose CT
Other Intervention Name(s)
LDCT
Intervention Description
All participants will have a low dose chest CT either within one year of enrollment or after enrollment
Primary Outcome Measure Information:
Title
Nodule detection rate
Description
Frequency of nodule detection
Time Frame
12 months
Title
High-risk nodule detection rate
Description
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
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Interstitial lung disease detection rate
Description
Frequency of interstitial lung disease detection
Time Frame
12 months
Title
Coronary artery calcification (CAC) ordinal scores
Description
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
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Administrator
Phone
6177249516
Email
mghfhs@partners.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erica T Warner, ScD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lecia V Sequist, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Administrator
Email
mghfhs@partners.org
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Lung Cancer Risk and Early Detection in Firefighters
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