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| Name | Class |
|---|---|
| Chung-Ang University Hospital | OTHER |
| KangWon National University Hospital | OTHER |
| Keimyung University Dongsan Medical Center | OTHER |
| SMG-SNU Boramae Medical Center |
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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.
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>
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KORNERSTONE | Glomerulonephritis (GN) such as Minimal change disease (MCD), focal segmental glomerulosclerosis (FSGS), Membranous nephropathy (MN), and Immunoglobulin A nephropathy (IgAN) Participants enrolled in KORNERSTONE with a biopsy proven GN. Eligible participants must be scheduled for a clinically indicated renal biopsy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Kidney Biopsy | Other | Patients scheduled to undergo a clinically indicated kidney biopsy will be requested to consent to an additional renal core and various patient-derived samples. |
| Measure | Description | Time Frame |
|---|---|---|
| Death | Documentation of death from any cause | 60 months |
| Deterioration of renal outcomes |
| 60 months |
| Improvement of clinical outcomes | Remission of glomerulonephritis and proteinuria <0.3g/day (pateint who have proteinuria<0.3g/day at baseline have no improvement in clinical outcomes) | 60 months |
| Measure | Description | Time Frame |
|---|---|---|
| Malignancies | Any cancer diagnosis of the skin, hematopoietic system, or solid organ after enrollment | 60 months |
| Infections, Serious and Systemic | Documented infection of any vital organ requiring the use of parenteral and/or oral antibiotics. |
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Inclusion criteria
Exclusion criteria - Patients who previously received a kidney transplant
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Patients suspected of glomerular diseases who received kidney biopsy in participating university medical centres are eligible for inclusion in the KORNERSTONE.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yong Chul Kim, MD,PhD. | Contact | +82-10-8874-7429 | imyongkim@gmail.com | |
| Eunyoung Kim | Contact | +82-2-6072-5188 | irish-key@nate.com |
| Name | Affiliation | Role |
|---|---|---|
| Dong Ki Kim, MD, PhD | Seoul National University Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KangWon National University Hospital | Recruiting | Chuncheon | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32842999 | Derived | 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. |
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De-identified individual participant data for all primary and secondary outcome measures will be made available.
Data will be available within 6 months of study completion.
Data access requests will be reviewed by an external independent Review Panel. Requestors will be required to sign a Data Access Agreement.
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| OTHER |
| Seoul National University Bundang Hospital | OTHER |
| Severance Hospital | OTHER |
| Ministry of Health & Welfare, Korea | OTHER_GOV |
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plasma, serum, genomic DNA, buffy coat, urine, stool, glomerular cDNA, tubulointerstitial cDNA, kidney biopsy slides (digitalized)
These sample are acquired at kidney biopsy, annually afterwords, and at the time of clinical endpoint if possible.
| 60 months |
| Acute Kidney Injury | Documented diagnosis of acute kidney injury as defined by the RIFLE criteria and/or renal failure requiring renal replacement therapy <3 months. | 60 months |
| Hospitalization | Documented hospital admission, including observation for ≥24 hours. | 60 months |
| Emergency Department/ Observation Unit Visit | Documented visit to an emergency department or observation unit that does not lead to hospitalization and is less than 24 hours. | 60 months |
| Cardiovascular/Cerebrovascular event | Myocardial infarction; Congestive heart failure; Primary intractable serious arrhythmia; Peripheral vascular disease; Ischemic cerebrovascular accident; Hemorrhagic cerebrovascular accident; Thromboembolic event | 60 months |
| New Onset Diabetes | Diagnosis of diabetes as indicated by 1 or more of the following not present at enrollment
| 60 months |
| Keimyung University Dongsan Medical Center | Recruiting | Daegu | South Korea |
|
| Chung-Ang University Hosptial | Recruiting | Seoul | South Korea |
|
| Seoul National University Hospital | Recruiting | Seoul | South Korea |
|
| Severance Hospital | Recruiting | Seoul | South Korea |
|
| SMG-SNU Boramae Medical Center | Recruiting | Seoul | South Korea |
|
| ID | Term |
|---|---|
| D009402 | Nephrosis, Lipoid |
| D005922 | Glomerulonephritis, IGA |
| D015433 | Glomerulonephritis, Membranous |
| D005923 | Glomerulosclerosis, Focal Segmental |
| D008181 | Lupus Nephritis |
| ID | Term |
|---|---|
| D009401 | Nephrosis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D008180 | Lupus Erythematosus, Systemic |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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