Photodynamic therapy (PDT) is a type of treatment used to treat cancer. The purpose of this research study is to collect information on patients treated with PDT so that we can determine if patient characteristics affect their response to PDT. We will collect information about medical history, life style habits like smoking, reports from the tissue taken during biopsy, and outcome of the treatment to include in the registry.
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 main objective of this study is to better understand the biomarkers of patients who are candidates for lung cancer screening. Biomarkers are biologic substances found in the blood and may be related to lung disease risk and detection. We intend to enroll volunteers who are participating in a lung cancer screening program at the Medical University of South Carolina and are being seen by a pulmonologist as part of their standard medical care. A single blood sample will be obtained at enrollment, then stored and analyzed to better understand the biomarkers found in blood and to help develop and test blood based screening or diagnostic tests. An additional blood collection at the 12 month follow up period will help determine any changes in biomarker activity over time. Active participation in this study will be over once the follow-up blood sample is obtained. However, we may conduct medical chart reviews of some participants for up to 27 months in order to look at their medical outcomes.
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.