P1.03-056 Implementation of a Prospective Biospecimen Collection Study in an Established Lung Cancer Screening Program

Abstract

Complexities such as addressing indeterminate pulmonary nodules (IPNs) are an inherent part of a lung screening program, and defining which individuals will benefit from invasive intervention is not always known. With the goal of combining non-invasive biomarkers with imaging to more definitively stratify patients, we initiated an investigational biospecimen collection process into our lung screening program. Ultimately, these biomarkers may improve specificity within the screening population, thereby reducing the overall cost and potential morbidity from false positive results of low-dose computed tomography scan (LDCT) screening. Studies like this are important to the ongoing improvement of lung cancer screening. NCCN high-risk individuals enrolled in a high volume clinical lung screening program were introduced to our IRB approved research biospecimen study at the time of the scheduling of their LDCT. Patients were consented, and routine biospecimens were collected by research staff at the time of their LDCT scan, including nasal epithelial brushings, buccal swabs and blood. When available, additional biospecimens consisting of bronchial airway brushings and tumor samples were collected from subjects who underwent diagnostic interventions for suspicion of malignancy. Since 2012 there have been 3856 patients enrolled and 8776 LDCT scans to date with 100 lung cancer diagnoses within our lung screening program. In 2014, funding (LUNGevity and Robert E Wise grants) was obtained for biospecimen collection from subjects enrolled in our institutional LDCT screening program. Initial prospective collection of biospecimens was slower than anticipated due to various factors. After review of the process, a number of adjustments were made, which significantly increased enrollment. This included implementation of a multidisciplinary taskforce consisting of research and clinical staff committed to patient outreach and participation. To date, samples from approximately 1420 subjects have been collected. Of these, 268 (19%) were found to have newly detected IPNs measuring 6-20mm on LDCT, and 28 samples were from patients with subsequent diagnoses of lung cancer. Successful coordination of biospecimen collection within a lung screening program is complex, but achievable with multidisciplinary coordination, and has great potential to help further stratify patients that may or may not benefit from invasive diagnostics and therapy. We demonstrate an established lung screening program that is successfully accruing to a prospective diagnostic study and share specific recommendations for how to successfully accrue in other programs.