Low-Dose CT for Lung Cancer Screening

(MAS-EXPAND Trial)

Enrolling by invitation at 6 trial locations
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: VA Office of Research and Development
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

JA

Jennifer A Lewis, MD MS MPH

Principal Investigator

Tennessee Valley Healthcare System Nashville Campus, Nashville, TN

Are You a Good Fit for This Trial?

This trial is for Veterans who may be at risk for lung cancer due to factors like smoking, toxic exposures (such as asbestos or Agent Orange), family history of lung cancer, or certain lung diseases. Participants are mainly adults being seen at select VA medical centers.

Inclusion Criteria

Active user of VA with at least 1 primary care encounter in prior 2 years at specified VAMCs (Nashville, Denver, Louisville, Chicago Jesse Brown, Kansas City, Salisbury, Seattle)
Self-reported tobacco use of at least 100 cigarettes in lifetime
Self-reported history of military service exposure to asbestos-containing material, agent orange, ionizing radiation, or burn pit
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Exclusion Criteria

Self-reported, family-reported or EHR diagnosis of dementia or failure of 3-word recall from Mini-cog during screening
Self-reported or EHR documented thoracic imaging surveillance for cancer or chronic lung disease
Pregnancy in second or third trimester
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What Are the Treatments Tested in This Trial?

Interventions

  • Low-dose computed tomography

Trial Overview

The study is testing whether expanding the criteria for low-dose chest CT scans helps find more cases of lung cancer in Veterans compared to current guidelines. It also looks at using blood tests (biomarkers) to better manage suspicious spots found on scans.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Expanded populationExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials
1,691
Recruited
3,759,000+

Bristol-Myers Squibb

Industry Sponsor

Trials
2,731
Recruited
4,127,000+
Headquarters
New York City, USA
Known For
Oncology & Cardiovascular
Top Products
Eliquis, Opdivo, Revlimid, Orencia
Christopher Boerner profile image

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt profile image

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania

Vanderbilt-Ingram Cancer Center

Collaborator

Trials
221
Recruited
64,400+