CureGN

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ABSTRACT Cure Glomerulonephropathy (CureGN) is a National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)-sponsored, multi-center international consortium established in 2013 to study the natural history of glomerular diseases (minimal change disease, focal segmental glomerulosclerosis, membranous nephropathy, and IgA nephropathy), understand their underlying biology, develop biomarkers to resolve disease heterogeneity, and ultimately improve therapeutic options. CureGN has made progress in: 1) establishing a large, ethnically diverse longitudinal observational cohort of glomerular disease patients; 2) creating a rich, well- curated clinical data set and linked biospecimens; 3) establishing the largest repository of digital kidney biopsies; and 4) an infrastructure that will facilitate translational and clinical research by core and ancillary study scientists. The establishment of a large digital pathology repository (DPR) has been key for the multicenter analysis of the kidney biopsy specimens. The DPR was originally hosted by Leica and has recently migrated to a new platform, HALOLink, hosted at the NIDDK, to enable sharing of the dataset with CureGN investigators as well as non- CureGN investigators who have approved studies, for the application of a variety of conventional and novel human vision and computer vision methodologies for tissue interrogation. A new DPR workflow was required for use with a new platform and software. This new workflow standardizes protocols across multiple research consortia and includes detailed functionality for tracking shipping of pathology materials, quality control processes, digital image transfers, and external user accessibility of digital pathology images. A detailed analysis of various steps required to implement a state-of-the-art DPR was performed and resulted in the identification of 5 major components to achieve the goals, and associated budget: (1) ArborLink Core Development, (2) ArborLink Core Study Configurations, (3) Study DCC operations, (4) Study Site operations, and (5) DPR management and curation. Given the complexity and volume of processes involving several consortia, the DCC has proposed centralization of training, tracking, oversight, management, and quality control that will ultimately result in improvement of efficiency of the workflow, provide a curated DPR dataset for core and ancillary studies, and ensure a financially responsible allocation of resources proportionate to the work that must be done. Without these capabilities, the consortia will not be able to reach their goal in building a central curated and searchable DPR that can be accessed by a variety of investigators for numerous research studies, and fulfil their mission.