Clinical Trials Directory

Trials / Recruiting

RecruitingNCT03929887

KOrea Renal Biobank NEtwoRk System TOward NExt-generation Analysis

Multicenter Prospective Cohort of Kidney Biopsy for Glomerular Disease Research

Status
Recruiting
Phase
—
Study type
Observational
Enrollment
3,000 (estimated)
Sponsor
Seoul National University Hospital · Academic / Other
Sex
All
Age
—
Healthy volunteers
Not accepted

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

Conditions

Interventions

TypeNameDescription
OTHERKidney BiopsyPatients scheduled to undergo a clinically indicated kidney biopsy will be requested to consent to an additional renal core and various patient-derived samples.

Timeline

Start date
2019-05-01
Primary completion
2028-12-31
Completion
2028-12-31
First posted
2019-04-29
Last updated
2020-02-12

Locations

6 sites across 1 country: South Korea

Source: ClinicalTrials.gov record NCT03929887. Inclusion in this directory is not an endorsement.