MCD/FSGS registry and digital nephropathology

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Both, minimal change disease (MCD) and focal-segmental glomerulosclerosis (FSGS) reflect histopathological patterns of injury caused by very different disease entities. Therefore, it is not surprising that large randomized clinical trials comparing the available treatment regimens are scarce. To overcome this limitation registry data are required. Within the framework of the central project CP3, we created a clinical registry for pediatric and adult patients with MCD or FSGS in the greater Cologne area with its approximately 5 million inhabitants – the FOrMe registry (The German Focal Segmental Glomerulosclerosis and Minimal Change Disease Registry). The FOrMe registry is compatible with the worldwide established NEPTUNE (Nephrotic Syndrome Study Network) registry with respect to operating procedures, structure and data fields, thus ensuring the compatibility and comparability of data with NEPTUNE and affiliated centers. Clinical data of all patients including results of genetic testing are systematically documented. In the second funding period of the CRU329, additional study centers in Germany are now to be included. In order to ensure data quality and at the same time relieve the work load on the participating centers, IT solutions will be created that enable automated data transfer of laboratory values. Furthermore, a digital nephropathology platform will be implemented. For this purpose, the kidney biopsy material will be centrally scanned by CP2, stored together with electron micrographs and systematically analyzed using mathematical algorithms. Furthermore, an evaluation is performed by an expert panel of nephropathologists. The FOrMe registry thus provides the basis for confirming the results of all individual projects on precisely annotated human biopsy and biomaterial in the sense of a truly translational approach.