Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
1000 participants
OBSERVATIONAL
2024-05-01
2040-01-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Evaluating Novel Biomarkers in Acute Kidney Injury
NCT01573104
Early Diagnosis of Postoperative Acute Renal Failure-using Biomarker to Predict Outcome of Cardiac Surgery Associated Acute Kidney Injury
NCT01503710
Urine and Serum Biomarkers for Early Detection of Acute Kidney Injury
NCT01531985
Search for New Methods to Detect Acute Renal Failure
NCT00026702
TIMP-2 and IGFBP7 for the Prediction of the Cardiac Surgery Associated Acute Kidney Injury
NCT02054546
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
RETROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Acute tubular injury (ATI) only
Kidney biopsy with features of acute tubular injury only, no other pathology detected
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
Concurrent diagnosis of acute tubular injury with any other pathology
Kidney biopsy with features of acute tubular injury AND other pathology. Non-ATI pathology includes but not limited to diagnosis of any type of glomerulonephritis, vasculitis, hereditary nephritis, thrombotic microangiopathy, kidney transplant rejection, podocytopathy, diabetic or hypertensive nephropathy, interstitial nephritis, pyelonephritis, amyloidosis, malignancy or paraneoplastic related kidney disease.
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
Biopsies with no acute tubular injury (neg control)
Kidney biopsy with any diagnosis other than (no features of) acute tubular injury
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Kidney biopsy sample sent to Westmead Hospital for clinical interpretation
Exclusion Criteria
2. Biopsy sample not available at Westmead Hospital
3. No information on kidney function (serum creatinine or eGFR)
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Western Sydney Local Health District
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Jennifer Li
CPI, Nephrologist and Transplant Physician
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
WESTKiD
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.