Abstract 3317: Development of a lung nodule cohort with integrated clinical, molecular and imaging biomarkers

Background: We are facing an epidemic of indeterminate pulmonary nodules (IPN). Current diagnostic strategies lack accuracy such that the management of IPNs 6-30 mm leads to an unacceptable rate of invasive biopsies and of missed opportunities for cure. Based on the critical need of evaluating candidate biomarkers across heterogeneous populations, we intended to assemble a large cohort of fully annotated IPNs from five collaborative institutions. Methods: Standard operating procedures (SOPs) were developed to capture subject demographics and assign consistent identifiers across clinical, bio-specimens, and imaging data. REDCap database was created for clinical, imaging and biospecimen data capture. Sample collection, processing, storage and shipping SOPs were created and shared among institutions to assure for consistency and quality accuracy. DICOM files, demographic and clinical data, blood and tissue samples were collected prospectively through IRB approved studies at each institution (VUMC, Nashville VAMC, Moffitt Cancer Center, and UPMC). Imaging studies and specimens were de-identified locally using custom JavaScript program in a secure web browser and assigned as specific identifier. De-identified thin slice, non-contrast chest CT studies were tested for quality control and transmitted to an imaging repository (eXtensible Neuroimaging Repository-XNAT) that can be mined by all collaborators. Results: To date, a cohort of 845 subjects, 507 (60%) males and 338 (40%) females, with lung nodules was assembled. 36 % are current smokers, 56 % former smokers and 8% never smokers, with an average of 46 pack year smoking history. Clinical data including risk prediction models such as the Mayo and PLCO m2012 are reported. Pathological confirmation of nodules is available for 322 benign and 444 malignant nodules. The cohort 283 lung adenocarcinomas, 71 squamous cell carcinomas, 53 small cell carcinoma, 17 non-small cell lung cancer, 9 carcinoid, and 79 subjects considered benign based on CT follow without growth. Serum, plasma and peripheral blood monocyte related DNA is available on all. All diagnostic chest CT are available in our thoracic imaging repository (XNAT) in a de-identified format. Conclusions: We assembled a unique cohort of incidental and screening detected lung nodules prospectively enrolled at four institutions for which full clinical data capture, chest CT DICOM files and blood specimens were collected. This repository allows the derivation and independent validation of candidate molecular and imaging biomarkers for the management of IPNs. This work is supported by UO1 152662, UO1CA186145 and UO1CA196405 Citation Format: Sanja Antic, Travis Osterman, Aneri Balar, Dhairya Lakhani, Rina Nguyen, Sara Block, Kimberly Fileds, Brandon Winston, Anel Muterspaugh, Yuankai Huo, Riqiang Gao, Joseph Leader, David Wilson, Viswam Nair, Robert Gillies, Matthew Schabath, Chirayu Shah, Bennett Landman, Pierre Massion. Development of a lung nodule cohort with integrated clinical, molecular and imaging biomarkers [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2019; 2019 Mar 29-Apr 3; Atlanta, GA. Philadelphia (PA): AACR; Cancer Res 2019;79(13 Suppl):Abstract nr 3317.