The primary objective of this study is to develop a blood-based gene expression signature, known as the ONC-LN-04 Lung Test, to be used in the detection of lung cancer in patients who underwent radiologic screening for lung cancer and had lung nodules detected. We intend to enroll volunteers who are being evaluated by a Medical University of South Carolina (MUSC) pulmonologist as part of their standard medical care. Participants will be current or former smokers, who have either (a) radiologic evidence of lung nodules, or (b) a confirmed diagnosis of non-small cell lung cancer (NSCLC) and has not undergone surgical excision, chemotherapy or radiation therapy for this malignancy. A single blood sample will be obtained from willing participants, then stored and analyzed for measurement of gene expression and development of the ONC-LN-04 test. Active participation in this study will be over once a blood sample is obtained; however, we may need access to participants' medical records post-enrollment and sample collection in order to monitor medical outcomes. Review of participants' medical records will occur until up to approximately 3,500 subjects have been enrolled and have provided clinical information and a blood sample.
The study will compare two sets of professionally-recommended guidelines for follow-up of patients with small lung nodules. The two guidelines are different in the frequency and timing of follow-up; one is more frequent and the one is less frequent. All patients who have a small lung nodule detected on a chest scan will have a recommended follow-up schedule automatically inserted into their imaging report so that their health care provider may follow the guideline-recommended intervals for follow-up chest scans. Patients and their physicians may choose not to follow the recommendations, depending on preference or the physician's clinical judgment. As part of this research study, information from patients with a small lung nodule who are seen at MUSC will be collected from the electronic medical record. This will include characteristics of the patient (such as age, smoking history), basic information about the lung nodule (such as nodule size, nodule density), and the medical care received.