Biobanking for glomerular diseases: a study design and protocol for KOrea Renal biobank NEtwoRk System TOward NExt-generation analysis (KORNERSTONE)
Authors: Kang Eunjeong , Kim Yaerim , Kim Yong Chul , Kim Eunyoung , Lee Nankyoung , Kim Yeonghui , Lee Soojin , Han Seungyeup , Choe Misun , Hwang Jin Ho , Lee Sunhwa , Park Ji In , Park Jung Tak , Lim Beom Jin , Lee Jung Pyo , An Jung Nam , Ryu Dong-Ryeol , Kim Jung-Hyun , Kang Hee Gyung , Lee Hyun Soon , Moon Kyung Chul , Joo Kwon Wook , Oh Kook-Hwan , Han Seung Seok , Lee Hajeong , Kim Dong Ki ,   on behalf of the KORNERSTONE Study Group, Lee Jung Pyo , An Jung Nam , Lee Jeonghwan , Park Jeonghwan , Kim Minjung , Kim Taekyoung , Kim Jinhyuk , Hwang Jin Ho , Park Eun A. , Park Eunji , In Park Ji , Lee Sun Hwa , Park Soyeong , Koh Nayoung , Han Seungyeup , Kim Yaerim , Choe Misun , Kim Yeonghui , Kim Dong Ki , Joo Kwon Wook , Oh Kook-Hwan , Lee Hajeong , Han Seung Seok , Kim Yong Chul , Kang Eunjeong , Lee Soojin , Moon Kyung Chul , Kang Hee Gyung , Kim Eunyoung , Kim Junghee , Park Ji Hye , Jeon Ji Won , Park Jung Tak , Lim Beom Jin , Kim Hyung Woo , Joo Young Su , Kim Kyungjoon , Nam Bo Young , Kim Eunyoung , Lee Nankyoung 
Published: August 2020

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.