Table 2 Inclusion/Exclusion criteria

DECAMP-1

 Inclusion Criteria

  • 45 years of age or older

  • Radiologic diagnosis of indeterminate pulmonary nodule (0.7 to 3.0 cm); must be of appropriate size at enrollment, but nodule(s) may have been first identified within 12 months prior; if multiple nodules were diagnosed, choose the one with the longest diameter as the target lesion; if two or more nodules are of the same largest size, choose the one with the perpendicular longest diameter

  • CT scan completed within 3 months prior to enrollment

  • Smoking status: Current or former cigarette smoker with ≥20 pack years (pack years = number of packs per day X number of years smoked)

  • Willing to undergo fiberoptic bronchoscopy

  • Able to tolerate all biospecimen collection as required by protocol

  • Able to comply with standard of care follow up visits including clinical exams, diagnostic work-ups, and imaging for approximately 2 years from enrollment

  • Able to fill out Patient Lung History questionnaire

  • Willing and able to provide a written informed consent

 Exclusion Criteria

  • History or previous diagnosis of lung cancer

  • Diagnosis of pure ground glass opacities for the target lesion on chest CT (i.e., mixed features on the target lesion and pure ground glass opacity on non-target lesions are acceptable)

  • Contraindications to nasal brushing or fiberoptic bronchoscopy, including: ulcerative nasal disease, hemodynamic instability, severe obstructive airway disease, unstable cardiac or pulmonary disease, inability to protect airway, or altered level of consciousness

  • Allergies to any local anesthetic that may be used to obtain biosamples in the study

DECAMP-2

 Inclusion Criteria

  • Ages 50 to 79 years

  • Smoking status: Current or former cigarette smoker (≥10 cigarettes/day for at least 25 years’ duration for current smokers, or ≥ 20 pack years for former smokers who quit 20 years ago or less)

  • History of Chronic Obstructive Pulmonary Disease (COPD), emphysema, or at least one first-degree relative with a diagnosis of lung cancer

  • Willing to undergo fiberoptic bronchoscopy

  • Able to tolerate all biospecimen collection as required by protocol

  • Able to comply with standard-of-care follow-up visits, including clinical exams, diagnostic work-ups, and imaging for a maximum of 4 years or until diagnosis of lung cancer

  • Able to fill out Patient Lung History questionnaire

  • Willing and able to provide a written informed consent

 Exclusion Criteria

  • Diagnosis of lung cancer prior to the current assessment

  • Contraindications to nasal brushing or fiberoptic bronchoscopy, including: ulcerative nasal disease, hemodynamic instability, severe obstructive airway disease (i.e., disease severity does not allow for bronchoscopic procedures), unstable cardiac or pulmonary disease, as well as other comorbidities leading to inability to protect airway, or altered level of consciousness

  • Pre-existing pulmonary nodule(s) only if the treating physician determines the nodule presents a risk for cancer

  • Allergies to any local anesthetic that may be used to obtain biosamples in the study

  • Weight greater than that allowable by the CT scanner