Clinical trial NCT03929887: KOrea Renal Biobank NEtwoRk System TOward NExt-generation Analysis
Official title: Multicenter Prospective Cohort of Kidney Biopsy for Glomerular Disease Research
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Glomerular Disease
Minimal Change Disease
IgA Nephropathy
Membranous Nephropathy
Focal Segmental Glomerulosclerosis
Lupus Nephritis
Crescentic Glomerulonephritis
Keywords: Glomerular disease
sample repository
clinical data
digital pathology repository
web-based database
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Chung-Ang University Hosptial, Chung-Ang University College of Medicine
name: KangWon National University Hospital
name: Keimyung University Dongsan Medical Center
name: SMG-SNU Boramae Medical Center
name: Seoul National University Bundang Hospital
name: Severance Hospital
name: Ministry of Health & Welfare, Korea
First posted: 2019-04-29
Enrollment: 3000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients suspected of glomerular diseases who received kidney biopsy in participating university medical centres are eligible for inclusion in the KORNERSTONE.

Brief summary: Glomerulonephritis (GN) generates an enormous individual and social economic burden. However, the therapeutic options are largely based on clinical and pathological parameters and the individual response to therapy or prognosis is uncertain.

Recently, along with advances in molecular analysis and computational bioinformatics, genomic data from human renal biopsies could provide a strong foundation for the future of precision medicine in nephrology.

In response to a request for applications by the Ministry of Health and Welfare of Korea for the creation of Clinical Research Registry, multi-center N network has been established for prospective cohort with kidney biopsy samples (KORNERSTONE).

Through this Network the investigators hope to understand the fundamental biology of glomerulonephritis and aim to bank long-term observational data and corresponding biological data including genomic data from kidney tissues, and kidney pathologic data which is digitalized This database is archived to a web-based platform to access easily and further enrich for researchers.

Detailed description: Glomerulonephritis (GN) such as Minimal change disease (MCD), focal segmental glomerulosclerosis (FSGS), Membranous nephropathy (MN), and Immunoglobulin A nephropathy (IgAN) has quite a common clinical presentation often results in renal insufficiency which generates an enormous individual and social economic burden.

However, the therapeutic options are largely based on clinical and pathological parameters and the individual response to therapy or prognosis is uncertain.

Recently, along with advances in molecular analysis and computational bioinformatics, genomic data from human renal biopsies could provide a strong foundation for the future of precision medicine in nephrology.

In response to a request for applications by the Ministry of Health and Welfare of Korea for the creation of Clinical Research Registry, a number of universities joined together to establish Korean Kidney Biopsy Network (KORNERSTONE).

Through this Network the investigators hope to understand the fundamental biology of glomerulonephritis and aim to bank long-term observational data and corresponding biological data including genomic data from kidney tissues, and kidney pathologic data which is digitalized This database is archived to a web-based platform to access easily and further enrich for researchers.

============ \<Patient clinical data will be collected as follows\>

1. Blood tests: CBC, Chemistry (Ca, P, Glucose, Total protein, Albumin, Uric acid), Electrolyte, Renal function (BUN, Creatinine, eGFR), Liver function (AST, ALT)
2. Immunologic blood tests: Complement 3, Complement 4, ASO, RF, Cryoglobulin, dsDNA, ANA
3. Urine tests: Urinalysis, Urine protein, Urine albumin, Urine creatinine
4. Radiologic tests: Kidney USG, Abdominal-pelvis computed tomography
5. Pathologic results
6. Treatment informations: treatment status, drug type, treatment duration
7. Quality of life questionnaire: Kidney Disease and Quality of Life Short Form survey (adults), PedsQL 4.0 Generic Core Scales (pediatrics)
8. Dietary questionnaire

Eligibility criteria: 1. Inclusion criteria

   * Patient suspected of glomerular disease who received kidney biopsy in participating university medical centers
   * Children (age\<18 years) also included
2. Exclusion criteria - Patients who previously received a kidney transplant

Primary outcomes:
measure: Death
timeFrame: 60 months
measure: Deterioration of renal outcomes
timeFrame: 60 months
measure: Improvement of clinical outcomes
timeFrame: 60 months
Secondary outcomes:
measure: Malignancies
timeFrame: 60 months
measure: Infections, Serious and Systemic
timeFrame: 60 months
measure: Acute Kidney Injury
timeFrame: 60 months
measure: Hospitalization
timeFrame: 60 months
measure: Emergency Department/ Observation Unit Visit
timeFrame: 60 months
measure: Cardiovascular/Cerebrovascular event
timeFrame: 60 months
measure: New Onset Diabetes
timeFrame: 60 months
Other outcomes:
Locations:
city: Chuncheon
country: Korea, Republic of
facility: KangWon National University Hospital
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
city: Seoul
country: Korea, Republic of
facility: Chung-Ang University Hosptial
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
city: Seoul
country: Korea, Republic of
facility: SMG-SNU Boramae Medical Center
Study officials:
affiliation: Seoul National University Hospital
name: Dong Ki Kim, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Kang E, Kim Y, Kim YC, Kim E, Lee N, Kim Y, Lee S, Han S, Choe M, Hwang JH, Lee S, Park JI, Park JT, Lim BJ, Lee JP, An JN, Ryu DR, Kim JH, Kang HG, Lee HS, Moon KC, Joo KW, Oh KH, Han SS, Lee H, Kim DK; KORNERSTONE Study Group. Biobanking for glomerular diseases: a study design and protocol for KOrea Renal biobank NEtwoRk System TOward NExt-generation analysis (KORNERSTONE). BMC Nephrol. 2020 Aug 26;21(1):367. doi: 10.1186/s12882-020-02016-z.