Western Sydney Kidney Injury Biopsy Study

Status Not yet recruiting

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.

Clinical Trial 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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06254677
Study type	Observational
Source	Western Sydney Local Health District
Contact
Status	Not yet recruiting
Phase
Start date	May 1, 2024
Completion date	January 1, 2040

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Western Sydney Kidney Injury Biopsy Study — WESTKiD

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms