Personalizing Veterans' Lung Cancer Screening and Diagnosis
MAS-EXPAND
2 other identifiers
interventional
1,400
1 country
7
Brief Summary
Lung cancer screening with low-dose chest computed tomography (CT) is currently recommended for high-risk individuals who are 50 to 80 years old, have smoked cigarettes for at least 20 pack-years, and currently smoke or quit smoking within the past 15 years. In a prospective cohort at Nashville, Denver, Louisville, Chicago, Kansas City, Salisbury and Seattle Veteran Affairs medical centers, the investigators will evaluate the detection of lung cancer using an expanded screening eligibility criteria based on Veterans' personal and service-related exposures compared to standard of care criteria. Screening a larger population will increase the number of lung nodules needing clinical management and these nodules may or may not be cancer. In a population of Veterans with positive screenings at Nashville, the investigators will also validate a combination biomarker-based approach to manage screen-detected lung nodules to reduce time to lung cancer diagnosis and use of invasive procedures. This study will also convene a Veteran Community Advisory Board and interview Veterans to better understand their thoughts about lung cancer screening and preferences for outreach and engagement.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2024
Longer than P75 for not_applicable
7 active sites
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
Study Start
First participant enrolled
April 3, 2024
CompletedFirst Submitted
Initial submission to the registry
September 9, 2026
CompletedFirst Posted
Study publicly available on registry
September 24, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
September 30, 2026
September 1, 2026
3.7 years
September 9, 2026
September 25, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Lung cancer incidence
The total number of lung cancers diagnosed in the cohort
3-44 months from time of study enrollment
Secondary Outcomes (1)
Positive Screening
3-44 months from time of study enrollment
Study Arms (1)
Expanded population
EXPERIMENTALAll study participants enrolled receive annual screening for lung cancer with low-dose computed tomography (LDCT)
Interventions
Eligibility Criteria
You may qualify if:
- Date of birth and sex recorded 2.Active user of VA (at least 1 primary care encounter in prior 2 years) at Nashville, Denver, Louisville, Chicago Jesse Brown, Kansas City, Salisbury or Seattle VAMC 3.Tobacco Use: Self-reported tobacco use of at least 100 cigarettes in lifetime 4.Additional Risk Factor
- Self-reported history of military service exposure: direct contact with asbestos- containing material, agent orange, ionizing radiation or burn pit
- Chronic obstructive pulmonary disease (COPD) defined as one of the two definitions below:
- Forced expiratory volume during the first second/forced vital capacity (FEV1/ FVC) ratio of below 70% predicted
- FEV1/FVC greater than 70% predicted or pulmonary function test (PFT) unavailable plus respiratory symptoms (chronic cough, sputum production, shortness of breath, chest tightness, wheezing) plus any one of the following functional abnormalities on PFTs or structural abnormalities on imaging:
- Functional abnormalities on PFTs:
- FEV1 below the lower limit of normal
- Gas trapping defined as residual volume greater than upper limit of normal
- Hyperinflation defined as two out of three lung volumes (total lung capacity, functional residual capacity, residual volume) that are greater than the upper limit of normal
- Reduced diffusion capacity of the lungs for carbon monoxide (DLCO) defined as DLCO lower than the lower limit of normal
- Rapid FEV1 decline defined as greater than 60ml/year or greater than or equal to 15% decline in FEV1
- Structural abnormalities on imaging:
- Emphysema
- Air trapping/mosaicism
- Self-reported prior history of tobacco-related cancer (oral cavity and pharynx, esophagus, stomach, colorectal, liver and intrahepatic bile duct, pancreas, larynx, lung and bronchus, cervix uteri, kidney and renal pelvis, urinary bladder, and acute non-lymphocytic leukemia) and without evidence of disease for at least 5 years based on chart review
You may not qualify if:
- Self-reported, family-reported or electronic health record (EHR) diagnosis of dementia via chart review or failure of 3-word recall from Mini-cog during study screening
- Self-reported or electronic health record (EHR) documented thoracic imaging surveillance for cancer or chronic lung disease
- Self-reported or EHR diagnosis of severe illness on chart review defined as:
- Hospice
- End Stage Pulmonary disease or continuous supplemental oxygen use
- Heart Failure with ejection fraction (EF) less than 25%
- Transplant of any organ or bone marrow
- Active cancer currently being treated except non-melanoma skin cancer
- Condition that precludes lung cancer screening due to limited ability to undergo treatment as deemed by study PI
- Pregnancy in the second or third trimester
- Inability to give informed consent; no minors, prisoners, or incapacitated
- Inability to complete computed tomography (CT) scan
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- VA Office of Research and Developmentlead
- Bristol-Myers Squibbcollaborator
- Vanderbilt-Ingram Cancer Centercollaborator
Study Sites (7)
Rocky Mountain Regional VA Medical Center, Aurora, CO
Aurora, Colorado, 80045-7211, United States
Jesse Brown VA Medical Center, Chicago, IL
Chicago, Illinois, 60612, United States
Robley Rex VA Medical Center, Louisville, KY
Louisville, Kentucky, 40206-1433, United States
Kansas City VA Medical Center, Kansas City, MO
Kansas City, Missouri, 64128-2226, United States
Salisbury W.G. (Bill) Hefner VA Medical Center, Salisbury, NC
Salisbury, North Carolina, 28144, United States
Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
Nashville, Tennessee, 37212-2637, United States
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, 98108-1532, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jennifer A Lewis, MD MS MPH
Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 9, 2026
First Posted
September 24, 2026
Study Start
April 3, 2024
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
December 31, 2027
Last Updated
September 30, 2026
Record last verified: 2026-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- IPD will be made available upon written request to the study PI within 24 months of publication of summary data and primary analysis.
- Access Criteria
- All data will need to be requested in writing to the Principal Investigator (Dr. Lewis). Requests will be reviewed and approved by the MAS-EXPAND Publications and Presentations Committee. Science advances through the systematic reproducibility and sharing of information. The Committee will assure: * IRB approval is granted by the requesting scientist and submitted for review with the written request * Agreement to release de-identified data is received by Dr. Lewis from VINCI, DOD * Data use agreements are in place restricting any attempt at re-identification of patients Final data sets will be maintained within the VA research servers and in accordance with VA Records Control Schedule. The above outlined steps will be taken prior to any data release: IRB approval and written request; Agreement to release from data sources (VINCI, DOD) and DUA in place with prohibition of re-identification.
Individual Participant Data, excluding Veterans' names and 38 USC 7332-protected information, will be shared pursuant to a written request to the Principal Investigator, Dr. Lewis, and IRB approved waiver of HIPAA authorization, with approval of the Under Secretary of Health, in accordance with the VHA Handbook. All final datasets will be maintained through VINCI. In manuscripts, the investigators will include a statement that "the protocol, statistical analysis plan and clinical study report are available from Dr. Lewis upon written request within 24 months of publication of summary data and primary analysis." We will include provisions that a de-identified and anonymized dataset will also be available upon request. If dataset requests are received then the investigators will create and share (excluding dates or PHI) under a written assurance prohibiting the recipient from identifying any individual whose data are included.