A Prospective Cohort Study of Chinese Patients With Pulmonary Nodules: Prediction of Lung Cancer Using Noninvasive Biomarkers

Inclusion Criteria:

• 18 Years and older, both male and female
• Willing and able to provide a written informed consent
• Radiologic diagnosis of solid indeterminate pulmonary nodule (5-30 mm) OR semi-solid (mixed density) nodule with solid component of at least 5mm OR non-solid nodule (including pGGO); must be of appropriate size at enrollment, but nodule(s) may havebeen first identified within 12 months prior. Furthermore, nodule(s) < 5 mm in sizemay have been first identified greater than 12 months prior to enrollment though itmust grow into the appropriate size range (5-30 mm) within 12 months prior toenrollment. If multiple nodules were diagnosed, choose the most representative onewith the longest diameter as the target lesion; if two or more nodules are of the samelargest size, choose the one with the perpendicular longest diameter
• CT scan completed within 3 months prior to enrollment
• Agree to tolerate all biospecimen collection as required by protocol
• Agree to comply with standard of care follow up visits including clinical exams,diagnostic work-ups, and imaging for 2~3 years from enrollment
• Agree to fill out Patient Lung History Questionnaire

Exclusion Criteria:

• History or previous diagnosis of primary lung cancer, metastatic lung cancer, or anyother non-lung cancer within 5 years (exceptions are adequately treated squamous andbasal cell carcinomas of the skin, carcinoma in situ of the cervix or breast)
• Any receipt of cytotoxic agents within the past 6 months
• Any symptoms of lung cancer (unexplained weight loss, recent hemoptysis)
• Pregnant or lactating women
• Underwent invasive biopsy procedures (e.g. bronchoscopies or CT-guided transthoracicbiopsies) before enrollment
• Receipt of transfusion within 30 days prior to enrollment
• Fail to understand or provide a written informed consent