MCD/FSGS registry and digital nephropathology

MCD/FSGS 登记和数字肾病理学

• 批准号: 398511713
• 负责人: Dr. Franziska Grundmann
• 金额: --
• 依托单位: Universitätsklinikum Köln
• 依托单位国家: 德国
• 项目类别: Clinical Research Units
• 资助国家: 德国
• 项目状态: 未结题
• 来源: https://gepris.dfg.de/gepris/projekt/398511713?language=en
• 关键词: MCD; FSGS; registry; digital; nephropathology

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.

微小病变病（MCD）和局灶节段性肾小球硬化（FSGS）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，需要登记数据。在中心项目CP 3的框架内，我们在拥有约500万居民的大科隆地区为患有MCD或FSGS的儿科和成人患者创建了一项临床登记研究-FOrMe登记研究（德国局灶性节段性肾小球硬化和微小病变疾病登记研究）。FOrMe登记研究在操作程序、结构和数据字段方面与全球公认的NEPTUNE（肾病综合征研究网络）登记研究兼容，从而确保与NEPTUNE及其附属中心的数据兼容性和可比性。所有患者的临床数据，包括基因检测结果，都有系统的记录。在CRU 329的第二个资助期，将纳入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，还将实施数字肾脏病理学平台。为此，将通过CP 2对肾脏活检材料进行集中扫描，与电子显微照片一起储存，并使用数学算法进行系统分析。此外，由肾脏病理学家专家小组进行评估。因此，FOrMe注册表提供了一个基础，用于确认所有精确注释的人类活检和生物材料的单个项目的结果，这是一种真正的转化方法。