GENETIC EPIDEMIOLOGY OF COPD (COPD GENE) 2024 - 2025 TASK ORDER FOR TASK AREA A: COLLECTION OF COPDGENE STUDY DATA AND BIOSPECIMENS AND OVERSIGHT OF THE COPDGENE STUDY.

Genetic Epidemiology of COPD (COPDGene) is a multi-site longitudinal cohort study of current and former smokers to better understand risk factors, natural history, and genetic contributions of chronic obstructive pulmonary disease (COPD) as well as other smoking-related diseases. The purpose of this acquisition is to fund a 15-year follow-up in-person clinical visit (Visit 4) of this cohort, to be re-enrolled from approximately 19 active Clinical Study Centers. A Visit 4 of COPDGene subjects is needed to identify clinical, physiological, imaging, and Omics determinants of COPD and other disease progression in elderly subjects, to assess the impact of COVID-19 on COPD and other disease progression, and to discover determinants of severe COPD development in subjects with preserved ratio, impaired spirometry (PRISm). The acquisition will also support the maintenance of previously collected data and biospecimens, regulatory oversight of the study, and analysis of study data and study biospecimens. The goal of COPDGene is to use extensive longitudinal imaging, physiology, and Omics molecular data in combination with genetics in the COPDGene cohort to identify high-risk subgroups with distinct diagnostic, prognostic, and therapeutic implications. COPDGene has been funded for 15 years through grants and cooperative agreements awarded by NHLBI to National Jewish Health and Brigham and Women's Hospital. Grant applications for the three Phases of COPDGene [Phase 1: baseline visit ("Visit 1"); Phase 2: five year follow-up ("Visit 2"); Phase 3: ten year follow-up ("Visit 3")] were all submitted to the parent NIH R01 Funding Opportunity Announcement. Study investigators originally recruited 10,198 current or former smokers in Phase 1. Including nonsmoking controls from both Phase 1 and Phase 2, COPDGene has recruited a total 10,718 subjects all of whom have been extensively phenotyped clinically and radiologically. Additional data collected on these participants include whole genome sequencing as well as RNA sequencing, proteomics, metabolomics, and DNA methylation data from collected blood samples. Investigators have published more than 450 publications, the vast majority of which were peer-reviewed, using COPDGene data. COPDGene also serves as a parent study for many ancillary studies, using public or private funding, a subset of which have collected additional data on all or a subset of participants. COPDGene is overseen by an NHLBI-convened Observational Study Monitoring Board (OSMB). The Visit 4 (15-year follow-up) evaluations will include, where possible, lung function tests (spirometry), questionnaires (including COVID-19 assessment), chest computerized tomography (CT), other functional assessments (e.g., six minute walk distance), and collection and storage of biospecimens from 3,500 of the original 10,718 COPDGene subjects. In addition, this acquisition will support continuation of semi-annual long-term follow-up of the COPDGene cohort and other contact with the cohort as needed, oversight of clinical sites and human subjects protection, maintenance of the database and biobank, continued coordination with NIH and NHLBI data resources, activities relevant to the data management and sharing plan, analysis of data, travel to meetings, and publication costs.