Liquid Biopsy for Early Non-small Lung Cancer Detection

Liquid Biopsy to Distinguish Malignant From Benign Pulmonary Nodules and to Monitor Response to Therapy

This clinical trial will assess the performance of a liquid biopsy assay to identify cancer in indeterminant pulmonary nodules identified by CT screening of high-risk individuals and evaluate the capability of the liquid biopsy assay to monitor response to surgical resection.

This clinical study examines the feasibility of a liquid biopsy methylation assay to detect non-small lung cancer. First, the investigators will apply their liquid biopsy assay to screen for lung cancer in indeterminate pulmonary nodules suspicious for cancer. Second, the investigators will assess the utility of liquid biopsy to assess tumor dynamics after surgical resection with curative intent. Third, the investigators will assess the presence or absence of this methylation assay in healthy normal persons without a history of lung cancer.

Indeterminate pulmonary nodule study cohort

• Inclusion criteria: Patients undergoing a biopsy of an indeterminate lung nodule by surgical excision, bronchoscopic biopsy or Interventional Radiology directed biopsy
• Exclusion criteria: No known concurrent cancer

Known lung cancer for surgical resection study cohort

• Inclusion criteria: Patients with known non-small cell lung cancer who will have surgical resection for treatment
• Exclusion criteria: N/A

Healthy volunteer cohort

• Inclusion criteria: Healthy persons
• Exclusion criteria: No known current cancer or history of cancer within 5 years

Benign lung disease cohort

• Inclusion criteria: Patients with the following categories of benign lung disease: COPD/emphysema, Granulomatous infection, Interstitial lung disease including pulmonary fibrosis and interstitial lung disease.
• Exclusion criteria: N/A