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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06254677
Other study ID # WESTKiD
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date May 1, 2024
Est. completion date January 1, 2040

Study information

Verified date April 2024
Source Western Sydney Local Health District
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 1000
Est. completion date January 1, 2040
Est. primary completion date January 1, 2035
Accepts healthy volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Western Sydney Local Health District

Outcome

Type Measure Description Time frame Safety issue
Primary Histopathology characteristics of acute tubular injury (ATI) Biopsy features including tubular dilatation, interstitial oedema, epithelial vacuolization and disrupted brush border integrity Specific for the biopsy/tissue, no time frame after
Primary Kidney function Kidney function based on blood tests collected from routine clinical care At biopsy (time 0) or during study follow up after biopsy (expected average 12-months)
Primary Correlation of biopsy findings with kidney function at time of biopsy and longitudinally Molecular signatures of injury At biopsy (time 0) or during study follow up after biopsy (expected average 12-months)
Secondary Surrogate end point of kidney function eGFR slope During study follow up after biopsy (expected average 12-months)
Secondary Albuminuria urine albumin to creatinine ratio At biopsy (time 0) or during study follow up after biopsy (expected average 12-months)
Secondary Time to renal recovery Kidney function return to baseline - based on any historical results before the biopsy date At biopsy (time 0) or during study follow up after biopsy (expected average 12-months)
Secondary Time to kidney failure Deterioration (or no recovery) in kidney function where dialysis or transplantation is needed to sustain life At biopsy (time 0) or during study follow up after biopsy (expected average 12-months)
Secondary Chronic kidney disease Deterioration (or without full recovery) in kidney function where chronic kidney disease is diagnosed based on clinical criteria At biopsy (time 0) or during study follow up after biopsy (expected average 12-months)
Secondary Response to treatment Response to non-supportive therapy (eg steroids) At biopsy (time 0) or during study follow up after biopsy (expected average 12-months)
Secondary Genomic signatures Transcriptomics (RNA) and microRNA (miRNA) extracted from the kidney biopsy At biopsy (time 0) or during study follow up after biopsy (expected average 12-months)
Secondary Cell types Detection of immune or kidney cell types on kidney biopsy At biopsy (time 0) or during study follow up after biopsy (expected average 12-months)
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