Ignite Creation Date:
2024-05-06 @ 8:06 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06254677
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-24
First Post:
2024-02-03
Brief Title:
Western Sydney Kidney Injury Biopsy Study
Sponsor:
Western Sydney Local Health District
Organization:
Western Sydney Local Health District
Study Overview
Official Title:
Western Sydney Kidney Injury Biopsy Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
WESTKiD
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None