Clinical trial · Interventional
Personalizing Veterans' Lung Cancer Screening and Diagnosis
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (10)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Agent Orange Exposure | — | UNRESOLVED | — |
| Asbestos Exposure | — | UNRESOLVED | — |
| Burn Pit Exposure | — | UNRESOLVED | — |
| Cancer Survivor | — | UNRESOLVED | — |
| COPD | — | UNRESOLVED | — |
| Family History of Lung Cancer | — | UNRESOLVED | — |
| Lung Cancer Screening | — | UNRESOLVED | — |
| Lung Neoplasm | Lung Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Military Service-related Environmental and Occupational Exposures | — | UNRESOLVED |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Low-dose computed tomography | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Expanded population
- description
- All study participants enrolled receive annual screening for lung cancer with low-dose computed tomography (LDCT)
- interventionNames
- Procedure: Low-dose computed tomography
Primary outcomes (1)
- measure
- Lung cancer incidence
- timeFrame
- 3-44 months from time of study enrollment
- description
- The total number of lung cancers diagnosed in the cohort
Secondary outcomes (1)
- measure
- Positive Screening
- timeFrame
- 3-44 months from time of study enrollment
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 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 1. Self-reported history of military service exposure: direct contact with asbestos- containing material, agent orange, ionizing radiation or burn pit 2. Chronic obstructive pulmonary disease (COPD) defined as one of the two definitions below: 1.Forced expiratory volume during the first second/forced vital capacity (FEV1/ FVC) ratio of below 70% predicted 2.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: 1. Functional abnormalities on PFTs: I.FEV1 below the lower limit of normal II.Gas trapping defined as residual volume greater than upper limit of normal III.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 IV.Reduced diffusion capacity of the lungs for carbon monoxide (DLCO) defined as DLCO lower than the lower limit of normal V.Rapid FEV1 decline defined as greater than 60ml/year or greater than or equal to 15% decline in FEV1 2. Structural abnormalities on imaging: I.Emphysema II.Air trapping/mosaicism 3. 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 4. Self-reported family history of primary lung cancer in a first degree relative 5.No exclusion criteria at study screening Exclusion Criteria: 1. 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 2. Self-reported or EHR documented thoracic imaging surveillance for cancer or chronic lung disease 3. Self-reported or EHR diagnosis of severe illness on chart review defined as: 1. Hospice 2. End Stage Pulmonary disease or continuous supplemental oxygen use 3. Heart Failure with ejection fraction (EF) less than 25% 4. Transplant of any organ or bone marrow 5. Active cancer currently being treated except non-melanoma skin cancer 6. Condition that precludes lung cancer screening due to limited ability to undergo treatment as deemed by study PI 4. Pregnancy in the second or third trimester 5. Inability to give informed consent; no minors, prisoners, or incapacitated 6. Inability to complete computed tomography (CT) scan
References
Publications (0)
Data not yet available