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Biobanking for glomerular diseases: a study design and protocol for KOrea Renal biobank NEtwoRk System TOward
Eunjeong Kang1, Yaerim Kim2, Yong Chul Kim3
1Department of Internal Medicine, Ewha Womans University Seoul Hospital, Ewha Womans University College of Medicine, Seoul, South Korea.
Insights
The KOrea Renal biobank NEtwoRk System TOward Next-generation analysis (KORNERSTONE) is a new biobank and cohort study for glomerular diseases. It collects biospecimens and deep clinical data to advance understanding and treatment of these kidney conditions.
Area of Science:
- Nephrology
- Genomics
- Biobanking
Background:
- Glomerular diseases significantly contribute to mortality and morbidity.
- Understanding their pathophysiology requires comprehensive biospecimens and detailed clinical data.
- The KOrea Renal biobank NEtwoRk System TOward Next-generation analysis (KORNERSTONE) initiative addresses this need.
Purpose of the Study:
- To establish a multi-center, prospective cohort study and biobank for glomerular diseases.
- To collect diverse biospecimens and deep clinical phenotyping data.
- To facilitate next-generation analysis for novel treatment targets and insights into glomerular diseases.
Main Methods:
- Prospective, multi-center cohort study design.
- Collection of clinical data, questionnaires, and biospecimens (serum, urine, cDNA, etc.) at baseline and follow-up.
- Standardized processing and storage of all data and biospecimens, linked to digital pathology and electronic health records.
Main Results:
- The KORNERSTONE study has been initiated with ethical approvals.
- A comprehensive dataset including clinical information, digital pathology, and biospecimens is being collected.
- Primary outcomes include mortality and end-stage renal disease, with secondary outcomes focusing on renal function, proteinuria, cardiovascular events, and quality of life.
Conclusions:
- KORNERSTONE provides a high-quality, integrated data resource for glomerular disease research.
- The study aims to yield pioneer insights into glomerular disease pathophysiology.
- This resource will support the development of individualized treatment strategies for glomerular diseases.
Backgrounds:
Glomerular diseases, a set of debilitating and complex disease entities, are related to mortality and morbidity. To gain insight into pathophysiology and novel treatment targets of glomerular disease, various types of biospecimens linked to deep clinical phenotyping including clinical information, digital pathology, and well-defined outcomes are required. We provide the rationale and design of the KOrea Renal biobank NEtwoRk System TOward Next-generation analysis (KORNERSTONE).
Methods:
The KORNERSTONE, which has been initiated by Korea Centres for Disease Control and Prevention, is designed as a multi-centre, prospective cohort study and biobank for glomerular diseases. Clinical data, questionnaires will be collected at the time of kidney biopsy and subsequently every 1 year after kidney biopsy. All of the clinical data will be extracted from the electrical health record and automatically uploaded to the web-based database. High-quality digital pathologies are obtained and connected in the database. Various types of biospecimens are collected at baseline and during follow-up: serum, urine, buffy coat, stool, glomerular complementary DNA (cDNA), tubulointerstitial cDNA. All data and biospecimens are processed and stored in a standardised manner. The primary outcomes are mortality and end-stage renal disease. The secondary outcomes will be deterioration renal function, remission of proteinuria, cardiovascular events and quality of life.
Discussion:
Ethical approval has been obtained from the institutional review board of each participating centre and ethics oversight committee. The KORNERSTONE is designed to deliver pioneer insights into glomerular diseases. The study design allows comprehensive, integrated and high-quality data collection on baseline laboratory findings, clinical outcomes including administrative data and digital pathologic images. This may provide various biospecimens and information to many researchers, establish the rationale for future more individualised treatment strategies for glomerular diseases.
Trial Registration:
NCT03929887 .
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