MCD/FSGS registry and digital nephropathology

微小改变病（MCD）和局灶节段性肾小球硬化（FSGS）都反映了由非常不同的疾病实体引起的损伤的组织病理学模式。因此，比较现有治疗方案的大型随机临床试验很少也就不足为奇了。为了克服这一限制，需要注册表数据。在中央项目CP3的框架内，我们为科隆地区约500万居民的儿童和成人MCD或FSGS患者创建了一个临床登记处- formme登记处（德国局灶性节段性肾小球硬化和微小变化疾病登记处）。FOrMe注册表在操作程序、结构和数据字段方面与全球建立的NEPTUNE（肾病综合征研究网络）注册表兼容，从而确保了与NEPTUNE及其附属中心数据的兼容性和可比性。所有患者的临床资料，包括基因检测结果，都被系统地记录下来。在CRU329的第二个资助期，现在将包括德国的其他研究中心。为了确保数据质量，同时减轻参与中心的工作量，将创建IT解决方案，实现实验室值的自动数据传输。此外，将实施数字肾脏病理学平台。为此，肾活检材料将被CP2集中扫描，与电子显微照片一起存储，并使用数学算法进行系统分析。此外，评估是由肾病专家小组进行的。因此，FOrMe注册表为确认所有个人项目的结果提供了基础，这些项目精确地注释了人体活检和生物材料，这是一种真正的翻译方法。

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.