Lung Cancer ScreeningMAS-EXPANDNCT07838519
Personalizing Veterans' Lung Cancer Screening and Diagnosis
A study testing Low-dose computed tomography in people with Lung Cancer Screening and Military Service-related Environmental and Occupational Exposures, run by VA Office of Research and Development at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Lung Cancer Screening, Military Service-related Environmental and Occupational Exposures, Cancer Survivor
- What is being tested?
- Low-dose computed tomography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,400 participants
- Where
- 7 sitesUnited States
- Study dates
- 3 Apr 2024to 31 Dec 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.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:
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- 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
- Self-reported family history of primary lung cancer in a first degree relative e .No exclusion criteria at study screening
Who cannot join
- 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%
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- 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
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites
Rocky Mountain Regional VA Medical Center, Aurora, CO
Aurora, Colorado, 80045-7211
Jesse Brown VA Medical Center, Chicago, IL
Chicago, Illinois, 60612
Kansas City VA Medical Center, Kansas City, MO
Kansas City, Missouri, 64128-2226
Robley Rex VA Medical Center, Louisville, KY
Louisville, Kentucky, 40206-1433
Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
Nashville, Tennessee, 37212-2637
Salisbury W.G. (Bill) Hefner VA Medical Center, Salisbury, NC
Salisbury, North Carolina, 28144
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, 98108-1532
About this study
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.
Read the detailed description
Annual lung cancer screening with low-dose computed tomography (LDCT) is recommended by the U.S. Preventive Services Task Force (USPSTF) for individuals aged 50-80 years with a ≥20 pack-year smoking history who currently smoke or quit within the past 15 years. However, USPSTF eligibility criteria identify only an estimated 45-65% of lung cancers that are ultimately diagnosed. Veterans face an increased risk of lung cancer due to higher rates of tobacco use and additional service-related exposures, including Agent Orange, asbestos, burn pits, and ionizing radiation.
This proof-of-concept, non-inferiority prospective cohort study aims to evaluate a personalized lung cancer screening protocol tailored to the Veteran population. The investigators will enroll 1,400 Veterans across seven VA medical centers (Nashville, Denver, Louisville, Chicago, Kansas City, Salisbury, and Seattle). Eligible participants will be 50-80 years old, have any history of cigarette smoking, and possess at least one additional lung cancer risk factor (COPD diagnosis, prior tobacco-related cancer, family history of lung cancer, or the above service-related exposures). Participants will undergo annual LDCT screening interpreted using standard-of-care Lung-RADS criteria.
The primary non-inferiority analysis will determine whether this expanded, Veteran-specific screening eligibility (experimental group) detects at least the same proportion of lung cancers as the historical cohort screened under USPSTF criteria within Lung Precision Oncology Program sites. A non-inferiority margin of 0.5% was selected based on clinical significance.
Because broader eligibility will increase the number of indeterminate pulmonary nodules, the investigators will also assess whether a combined biomarker strategy can improve diagnostic efficiency. Among 520 Nashville Veterans with positive LDCT results, the investigators will test whether pairing image-based biomarkers with blood-based biomarkers reduces invasive procedures and shortens time to diagnosis compared with the Brock Model.
The investigators hypothesize that the Veteran-specific screening criteria will be non-inferior to USPSTF criteria in lung cancer incidence detected and that a combined biomarker approach will reduce unnecessary procedures and accelerate diagnostic timelines for Veterans with positive screening findings. This study will provide proof-of-concept evidence supporting personalized lung cancer screening for Veterans and the integration of biomarker-guided management for screen-detected indeterminate pulmonary nodules.
This study also includes a Community Advisory Board (CAB) composed of Veterans, members of Veteran organizations, and Veteran family members (n=15). The purpose of the CAB is to incorporate Veteran perspectives on study progress. The CAB will also inform dissemination of all study results to the community, including any lay written report and presentations to the community. The investigators will conduct semi-structured interviews (n=60 or until thematic saturation is reached) with Veterans who have undergone lung cancer screening as part of expanded criteria and usual screening criteria (USPSTF). These interviews will assess Veteran preferences for lung cancer screening outreach and engagement.
- Conditions
- Lung Cancer Screening, Military Service-related Environmental and Occupational Exposures, Cancer Survivor, Family History of Lung Cancer, COPD, Burn Pit Exposure
- Being tested
- Low-dose computed tomography
- Keywords
- Veterans, lung cancer screening, military health, occupational exposure, environmental exposure, Agent Orange, asbestos, radiation, open waste burning, military deployment, COPD, Cancer survivor, lung neoplasm
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-dose computed tomographyProcedure or surgery
CT exam that uses low-dose radiation
| Study group | Role | What they receive |
|---|---|---|
| Expanded population | Experimental | All study participants enrolled receive annual screening for lung cancer with low-dose computed tomography (LDCT) Receives: Procedure: Low-dose computed tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung cancer incidence
The total number of lung cancers diagnosed in the cohort
Measured: 3-44 months from time of study enrollment
Secondary outcomes (1)
Positive Screening
The number of LungRADS 3s and 4s from screening exams
Measured: 3-44 months from time of study enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2026
- Study start3 Apr 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer ScreeningStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Low-dose Computed Tomography (LDCT) exam
- Masking
- None (open label)
- Enrolment
- 1,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- Bristol-Myers Squibb, Vanderbilt-Ingram Cancer Center
- Responsible party
- Sponsor
- Investigators
- Jennifer A Lewis, MD MS MPH, Principal investigator, Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07838519
- Sponsor's protocol ID
- ONCB-002-22F
- Other IDs
- 5I01CX002686-02
- Acronym
- MAS-EXPAND
- Status last verified
- Sep 2026
- First submitted
- 9 Sep 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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." The investigators 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.