2016-11: Blood Sample Collection in Subjects Participating in a Lung Cancer Screening Program
The primary objective of this study is to establish a control population to assess performance of an investigational diagnostic test targeting lung neoplasms.
• Subject is male or female, 50 years of age or older.
• Subject meets one of two lung cancer screening criteria below.
‣ Subject is a candidate for LDCT lung cancer screening and is scheduled for a baseline LDCT scan. There may be circumstances when a patient cannot have an LDCT scan (e.g., due to insurance issues). In these cases, it is allowable for a patient to have a CT scan in order to meet the inclusion criteria. OR
⁃ Subject has had previous LDCT scan(s) for lung cancer screening and the most recent LDCT scan prior to enrollment is negative for pulmonary nodules (Lung-RADS category 1, no nodules).
• Subject understands the study procedures and is able to provide informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator.