Clinical trial NCT06254677: Western Sydney Kidney Injury Biopsy Study
Official title: Western Sydney Kidney Injury Biopsy Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Kidney Injury
Lead sponsor: Western Sydney Local Health District
Sponsor class: OTHER
First posted: 2024-02-12
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who had a kidney biopsy performed for any clinical indication, with biopsy sample sent to Westmead Hospital for review

Brief 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

Eligibility criteria: Inclusion Criteria:

1. Had a kidney biopsy (native kidney or transplant kidney included) after year 2000
2. Kidney biopsy sample sent to Westmead Hospital for clinical interpretation

Exclusion Criteria:

1. Patients who have never had a kidney biopsy performed
2. Biopsy sample not available at Westmead Hospital
3. No information on kidney function (serum creatinine or eGFR)

Primary outcomes:
measure: Histopathology characteristics of acute tubular injury (ATI)
timeFrame: Specific for the biopsy/tissue, no time frame after
measure: Kidney function
timeFrame: At biopsy (time 0) or during study follow up after biopsy (expected average 12-months)
measure: Correlation of biopsy findings with kidney function at time of biopsy and longitudinally
timeFrame: At biopsy (time 0) or during study follow up after biopsy (expected average 12-months)
Secondary outcomes:
measure: Surrogate end point of kidney function
timeFrame: During study follow up after biopsy (expected average 12-months)
measure: Albuminuria
timeFrame: At biopsy (time 0) or during study follow up after biopsy (expected average 12-months)
measure: Time to renal recovery
timeFrame: At biopsy (time 0) or during study follow up after biopsy (expected average 12-months)
measure: Time to kidney failure
timeFrame: At biopsy (time 0) or during study follow up after biopsy (expected average 12-months)
measure: Chronic kidney disease
timeFrame: At biopsy (time 0) or during study follow up after biopsy (expected average 12-months)
measure: Response to treatment
timeFrame: At biopsy (time 0) or during study follow up after biopsy (expected average 12-months)
measure: Genomic signatures
timeFrame: At biopsy (time 0) or during study follow up after biopsy (expected average 12-months)
measure: Cell types
timeFrame: At biopsy (time 0) or during study follow up after biopsy (expected average 12-months)
Other outcomes:
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