Clinical Core

CLINICAL CORE: ABSTRACT The central mission of the Clinical Core (CC) is to oversee all aspects of clinical study development, patient recruitment and specimen collection for analysis in the Center's scientific projects. The CC is led by Drs. Paul Bunn, Philip Mack, and Jorge Gomez. Together with co-investigators Dr. Brody (Director of Mount Sinai Cancer Biorepository) and Drs. Henschke and Yankelevitz (Directors of the Mount Sinai Lung Cancer Screening Network), the CC brings to bear a wealth of experience in clinical trials development, translational medicine and biorepository management. As described in Aim 1, the CC will be responsible for development, compliance, IRB-approval, implementation and monitoring of the clinical study that serves as the basis for this U54 Center. A foremost responsibility of the CC will be to rigorously maintain all regulatory, safety, privacy, confidentiality and compliance elements necessary for clinical study enrollment. Leveraging the experience and infrastructure of the Mount Sinai Tisch Cancer Institute Clinical Trials Office, the CC will oversee all study enrollment, following all HIPAA and regulatory compliance elements. While developed and managed by the CC, the study will be implemented in close partnership with the Data Science Core, and Project Investigators, under the guidance of the Center leadership and Steering Committee. In Aim 2, the CC will Identify and enroll lung cancer and control subjects onto the study, collecting the required longitudinal clinical information and serial blood specimens. Lung cancer patients will be recruited mostly from Mount Sinai. Some patients of special interest (younger, minorities) will be recruited through the GO2 Foundation for Lung Cancer network. Non-lung cancer matched controls will be recruited from the Mount Sinai Lung Cancer Screening Program, and will be composed of individuals with no evidence of lung cancer and no active cancer within the last 5 years (except skin cancer), matched by age, gender, ethnicity and tobacco smoking history. As vaccines become available, recruitment will segue from studying antibody response to natural infection with SARS-CoV-2 to vaccine-induced antibodies responses. Aim 3 addresses the collection, processing, storage, encoding and delivery of high-quality specimens to Project Investigators. From all study participants, blood specimens will be collected prospectively at baseline, and 3, 6, 12 and 24 month following enrollment. The CC will serve as a conduit between the Projects and the Data Science Core by providing HIPAA-compliant data and samples that have been anonymized to the project investigators conducting assays. The CC will utilize the existing infrastructure of the Tisch Cancer Institute's Biorepository, maintaining its own partitioned, password-protected database and dedicated, well- monitored freezer space.