DECAMP 1 PLUS: Prediction of Lung Cancer Using Noninvasive Biomarkers

Inclusion Criteria:

• Radiologic diagnosis of solid indeterminate pulmonary nodule (0.8 to 2.5 cm)identified in the past 3 months OR semi-solid (mixed density) nodule with solidcomponent of at least 0.6 cm identified in the past 12 months; must be ofappropriate size at enrollment.

• CT scan completed within 3 months prior to enrollment

• 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 three years from enrollment

• Able to complete the Patient Lung History questionnaire with study staff

Arm 1 - Screening

• Age 55-77 years old

• Current and former smokers with 30 pack-years or more(and quit less than 15 yearsago)

Arm 2 - Incidental

• Age > 45 years old

• Current and former smokers with 10 pack-years or more(and quit less than 15 yearsago)

Exclusion Criteria:

• History or previous diagnosis of primary lung cancer, metastatic lung cancer, or anyother non-lung cancer within 5 years (not including non-melanoma skin cancer)

• Symptoms of lung cancer (unexplained weight loss 10 lbs or more in 3 months, recenthemoptysis)

• Diagnosis of pure ground glass opacities for the target lesion on chest CT withinthe last 12 months (i.e., mixed features on the target lesion and pure ground glassopacity on non-target lesions are acceptable as mentioned above)