Biomarkers for Diagnosis of Lung Cancer

Inclusion criteria

• Adults ≥ 18 years of age
• Patients referred to pulmonologists, oncologists, or thoracic surgeons for diagnosis of suspicious pulmonary nodules as either lung cancer or benign and undergoing bronchoscopic biopsy
• Patients will be enrolled if the result of the bronchoscopic biopsy is a diagnosis of NSCLC or benign pulmonary nodule
• Cases: Patients with untreated non-small cell lung cancer, i.e. primary lung adenocarcinoma or squamous cell carcinoma of early
• Computed tomography or X-Ray is available and shows a suspicious pulmonary nodule
• A biopsy or surgical resection to clarify the nature of the lung nodule is available (NSCLC or benign, including histological diagnosis) in both groups
• Controls: Patients must be available for a 6 month follow-up to confirm benign diagnosis
• A serum and plasma sample was collected prior to any treatment of the lung nodule beyond biopsy
• No other cancer diagnosis in the last 5 years excluding non-melanoma skin cancer
• Patients must be fully informed of the investigational nature of the procedure and sign an informed consent.

Exclusion criteria

• Prior treatment for lung cancer by chemotherapy or surgery (excluding biopsy)
• Patients with benign nodules who are not able or willing to have a 6-month follow-up visit to confirm benign diagnosis
• Diagnosis or treatment of other cancer in the last 5 years excluding non-melanoma skin cancer. In the judgment of the clinical investigator, patients who are likely to be non compliant or uncooperative during the study.