KOrea Renal Biobank NEtwoRk System TOward NExt-generation Analysis

Официальное название

Multicenter Prospective Cohort of Kidney Biopsy for Glomerular Disease Research

Обзор

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.

Подробное описание

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

Вмешательства

• Другое Kidney Biopsy
  Patients scheduled to undergo a clinically indicated kidney biopsy will be requested to consent to an additional renal core and various patient-derived samples.

Первичные конечные точки

• Death [Срок оценки: 60 months]
• Deterioration of renal outcomes [Срок оценки: 60 months]
• Improvement of clinical outcomes [Срок оценки: 60 months]

Вторичные конечные точки (7)

• Malignancies [Срок оценки: 60 months]
• Infections, Serious and Systemic [Срок оценки: 60 months]
• Acute Kidney Injury [Срок оценки: 60 months]
• Hospitalization [Срок оценки: 60 months]
• Emergency Department/ Observation Unit Visit [Срок оценки: 60 months]
• Cardiovascular/Cerebrovascular event [Срок оценки: 60 months]
• New Onset Diabetes [Срок оценки: 60 months]

Критерии участия

• Inclusion criteria

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

South Korea · 6 центров

• KangWon National University Hospital — Chuncheon
• Keimyung University Dongsan Medical Center — Daegu
• Chung-Ang University Hosptial — Seoul
• Seoul National University Hospital — Seoul
• Severance Hospital — Seoul
• SMG-SNU Boramae Medical Center — Seoul

Публикации

• 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 PMID 32842999

Идентификаторы

NCT: NCT03929887 · KORNERSTONE

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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