NCT06254677

Western Sydney Kidney Injury Biopsy Study

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: Western Sydney Local Health District · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: —

Summary

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.

Detailed description

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 1. Had a kidney transplant at any time after the year 2000 2. Kidney biopsy sample sent to Westmead Hospital for clinical interpretation 3. Have information regarding kidney function available. This will include groups with 1. Acute tubular injury (ATI) only 2. ATI concurrently diagnosed with any other pathology on biopsy 3. Biopsies with no ATI (negative control) Collection of health related data will be through review of primary medical records to improve the diagnostic utility of kidney biopsies performed to evaluate the cause of AKI. The investigators will also be requesting waiver of consent for access to histopathology slides and residual kidney tissue * Histopathology slides, which were created and analysed as part of routine clinical care. * Residual kidney tissue, either as paraffin blocks or fresh frozen tissue

Conditions

• Kidney Injury

Interventions

Type	Name	Description
OTHER	Retrospective review of histological features	Correlate histopathology characteristics of acute kidney injury with molecular signatures, kidney function and aetiology of acute kidney injury to derive clinically validated scoring system for acute kidney injury and acute tubular injury

Timeline

• Start date: 2024-05-01
• Primary completion: 2035-01-01
• Completion: 2040-01-01
• First posted: 2024-02-12
• Last updated: 2024-04-24