Biobanking for glomerular diseases: a study design and protocol for KOrea Renal biobank NEtwoRk System TOward NExt-generation analysis (KORNERSTONE)

Eunjeong Kang, Yaerim Kim, Yong Chul Kim, Eunyoung Kim, Nankyoung Lee, Yeonghui Kim, Soojin Lee, Seungyeup Han, Misun Choe, Jin Ho Hwang, Sunhwa Lee, Ji In Park, Jung Tak Park, Beom Jin Lim, Jung Pyo Lee, Jung Nam An, Dong-Ryeol Ryu, Jung-Hyun Kim, Hee Gyung Kang, Hyun Soon Lee, Kyung Chul Moon, Kwon Wook Joo, Kook-Hwan Oh, Seung Seok Han, Hajeong Lee, Dong Ki Kim, KORNERSTONE Study Group, Jung Pyo Lee, Jung Nam An, Jeonghwan Lee, Jeonghwan Park, Minjung Kim, Taekyoung Kim, Jinhyuk Kim, Jin Ho Hwang, Eun A Park, Eunji Park, Ji In Park, Sun Hwa Lee, Soyeong Park, Nayoung Koh, Seungyeup Han, Yaerim Kim, Misun Choe, Yeonghui Kim, Dong Ki Kim, Kwon Wook Joo, Kook-Hwan Oh, Hajeong Lee, Seung Seok Han, Yong Chul Kim, Eunjeong Kang, Soojin Lee, Kyung Chul Moon, Hee Gyung Kang, Eunyoung Kim, Junghee Kim, Ji Hye Park, Ji Won Jeon, Jung Tak Park, Beom Jin Lim, Hyung Woo Kim, Young Su Joo, Kyungjoon Kim, Bo Young Nam, Eunyoung Kim, Nankyoung Lee, Eunjeong Kang, Yaerim Kim, Yong Chul Kim, Eunyoung Kim, Nankyoung Lee, Yeonghui Kim, Soojin Lee, Seungyeup Han, Misun Choe, Jin Ho Hwang, Sunhwa Lee, Ji In Park, Jung Tak Park, Beom Jin Lim, Jung Pyo Lee, Jung Nam An, Dong-Ryeol Ryu, Jung-Hyun Kim, Hee Gyung Kang, Hyun Soon Lee, Kyung Chul Moon, Kwon Wook Joo, Kook-Hwan Oh, Seung Seok Han, Hajeong Lee, Dong Ki Kim, KORNERSTONE Study Group, Jung Pyo Lee, Jung Nam An, Jeonghwan Lee, Jeonghwan Park, Minjung Kim, Taekyoung Kim, Jinhyuk Kim, Jin Ho Hwang, Eun A Park, Eunji Park, Ji In Park, Sun Hwa Lee, Soyeong Park, Nayoung Koh, Seungyeup Han, Yaerim Kim, Misun Choe, Yeonghui Kim, Dong Ki Kim, Kwon Wook Joo, Kook-Hwan Oh, Hajeong Lee, Seung Seok Han, Yong Chul Kim, Eunjeong Kang, Soojin Lee, Kyung Chul Moon, Hee Gyung Kang, Eunyoung Kim, Junghee Kim, Ji Hye Park, Ji Won Jeon, Jung Tak Park, Beom Jin Lim, Hyung Woo Kim, Young Su Joo, Kyungjoon Kim, Bo Young Nam, Eunyoung Kim, Nankyoung Lee

Abstract

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 .

Keywords: Glomerulonephritis; Nephrology; Pathology.

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Overall schemes of the KORNERSTONE. KORNERSTONE, Korea Glomerular disease Biobank Network; gDNA, genomic DNA; OPD, outpatient; EHR, electronic health record; LM, light microscopy; IF, immunofluorescence; EM, electron microscopy; QC, quality control; VPN, virtual private network
Fig. 2
Fig. 2
Digital pathology repository. LM, light microscopy; IF, immunofluorescence; EM, electron microscopy
Fig. 3
Fig. 3
KORNERSTONE governance structure. KORNERSTONE, Korea Glomerular disease Biobank Network; DB, database; KCDC, Korea Centers for Disease Control and Prevention
Fig. 4
Fig. 4
Application and dissemination process of the KORNERSTONE. KORNERSTONE, Korea Glomerular disease Biobank Network; KCDC, Korea Centers for Disease Control and Prevention

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