Western Sydney Kidney Injury Biopsy Study
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Retrospective review of histological features.
- Кому может быть актуально
- Состояния в реестре: Kidney Injury. Базовые параметры: 18 лет — 80 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Список центров уточняется — проверьте первичный протокол.
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
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.
Подробное описание
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
Вмешательства
- Другое 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
Первичные конечные точки
- Histopathology characteristics of acute tubular injury (ATI) [Срок оценки: Specific for the biopsy/tissue, no time frame after]
- Kidney function [Срок оценки: At biopsy (time 0) or during study follow up after biopsy (expected average 12-months)]
- Correlation of biopsy findings with kidney function at time of biopsy and longitudinally [Срок оценки: At biopsy (time 0) or during study follow up after biopsy (expected average 12-months)]
Вторичные конечные точки (8)
- Surrogate end point of kidney function [Срок оценки: During study follow up after biopsy (expected average 12-months)]
- Albuminuria [Срок оценки: At biopsy (time 0) or during study follow up after biopsy (expected average 12-months)]
- Time to renal recovery [Срок оценки: At biopsy (time 0) or during study follow up after biopsy (expected average 12-months)]
- Time to kidney failure [Срок оценки: At biopsy (time 0) or during study follow up after biopsy (expected average 12-months)]
- Chronic kidney disease [Срок оценки: At biopsy (time 0) or during study follow up after biopsy (expected average 12-months)]
- Response to treatment [Срок оценки: At biopsy (time 0) or during study follow up after biopsy (expected average 12-months)]
- Genomic signatures [Срок оценки: At biopsy (time 0) or during study follow up after biopsy (expected average 12-months)]
- Cell types [Срок оценки: At biopsy (time 0) or during study follow up after biopsy (expected average 12-months)]
Критерии участия
Критерии включения
- Had a kidney biopsy (native kidney or transplant kidney included) after year 2000
- Kidney biopsy sample sent to Westmead Hospital for clinical interpretation
Критерии исключения
- Patients who have never had a kidney biopsy performed
- Biopsy sample not available at Westmead Hospital
- No information on kidney function (serum creatinine or eGFR)
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Список центров уточняется — проверьте первичный протокол.
Идентификаторы
NCT: NCT06254677 · WESTKiD