Western Sydney Kidney Injury Biopsy Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,000
- 主要终点
- Histopathology characteristics of acute tubular injury (ATI)
研究概览
简要总结
The investigators aim to develop a clinically validated, histological acute tubular injury (ATI) scoring system to help improve diagnostic precision and predict clinical outcomes following ATI.
To use an unbiased, data-driven approach, correlating pathological features (including digital pathology), key signatures using spatial technologies (transcriptomics or proteinomics) with relevant clinical outcomes. Spatial technologies (including spatial transcriptomics and spatial proteinomics) allow the use of 'precision pathology' to study the critical link between molecular characteristics to histological structure.
详细描述
The study is an investigator-led, retrospective, observational cohort study. This study is intended to be in perpetuity and there will be regular reporting to the local HREC (Western Sydney Local Health District, WSLHD)
Primary aim: the investigators aim to derive a clinically validated scoring system for acute kidney injury and iteratively improve its performance through machine learning algorithms over time.
Secondary aims:
- Derive a spatially resolved transcriptomic signature of acute kidney injury (AKI)
- Derive accurate transcriptomic signatures aligned with key cell types in AKI
- Derive unique gene signatures to differentiate different causes of AKI
All participants included in the study must be age ≥ 18 years old at time of enrolment and
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Had a kidney biopsy (native kidney or transplant kidney included) after year 2000
- •Kidney biopsy sample sent to Westmead Hospital for clinical interpretation
排除标准
- •Patients who have never had a kidney biopsy performed
- •Biopsy sample not available at Westmead Hospital
- •No information on kidney function (serum creatinine or eGFR)
结局指标
主要结局
Histopathology characteristics of acute tubular injury (ATI)
时间窗: Specific for the biopsy/tissue, no time frame after
Biopsy features including tubular dilatation, interstitial oedema, epithelial vacuolization and disrupted brush border integrity
Correlation of biopsy findings with kidney function at time of biopsy and longitudinally
时间窗: At biopsy (time 0) or during study follow up after biopsy (expected average 12-months)
Molecular signatures of injury
Kidney function
时间窗: At biopsy (time 0) or during study follow up after biopsy (expected average 12-months)
Kidney function based on blood tests collected from routine clinical care
次要结局
- Albuminuria(At biopsy (time 0) or during study follow up after biopsy (expected average 12-months))
- Chronic kidney disease(At biopsy (time 0) or during study follow up after biopsy (expected average 12-months))
- Genomic signatures(At biopsy (time 0) or during study follow up after biopsy (expected average 12-months))
- Time to renal recovery(At biopsy (time 0) or during study follow up after biopsy (expected average 12-months))
- Surrogate end point of kidney function(During study follow up after biopsy (expected average 12-months))
- Response to treatment(At biopsy (time 0) or during study follow up after biopsy (expected average 12-months))
- Cell types(At biopsy (time 0) or during study follow up after biopsy (expected average 12-months))
- Time to kidney failure(At biopsy (time 0) or during study follow up after biopsy (expected average 12-months))
研究者
Jennifer Li
CPI, Nephrologist and Transplant Physician
Western Sydney Local Health District