study design
Biospecimens & digital pathology
1. Biospecimens
- Eight types of biospecimens will be collected: plasma, serum, buffy coat, genomic DNA, urine, stools, stool DNA and cDNA from glomeruli and tubules in microdissected kidney biopsy tissues .
- From one participant in the KORNERSTONE, at least one SST tube and two EDTA tubes with blood (8 cc per tube, total 24 cc), more than 10 cc of urine, more than 1 g in 2 bottles of stool, stool DNA, and at least one core of kidney biopsy tissue will be collected.
Parameters | Detailed information | Screening | Baseline | 1 Y | 2 Y | 3 Y | 4 Y | 5 Y | Improvement or deterioration of clinical outcomes |
Hard outcomes (ESRD, CV outcomes) |
---|---|---|---|---|---|---|---|---|---|---|
Biospeci mens | Serum/plasma/buffy coat/genomic DNA sample |
O | O | O | O | O | O | O | O | O |
Urine sample | O | O | O | O | O | O | O | O | O | |
Stool sample | O | |||||||||
cDNA from glomeruli and tubules in micro-dissected kidney biopsy tissues |
O |
2. Digital pathology
- Kidney biopsy materials from enrolled patients, including glass slides scanned into high-resolution whole slide images, both stained and non-stained;
digital images of immunofluorescence and electron-micrographs; and pathologic reports from each centre will be collected and uploaded into the KORNERSTONE Digital Pathology Repository.