Набор по приглашению NCT06288425

Spatial Transcriptomics in Kidney Transplantation

— Наблюдательное Transplant Complication Kidney Injury

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: Non interventional.
Кому может быть актуально: Состояния в реестре: Transplant Complication, Kidney Injury. Базовые параметры: 18 лет — 75 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: Австралия
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 study is an investigator-led, prospective, longitudinal, observational cohort study. The central hypothesis for this study is that spatial data will reveal new insights to immune cell function and local interactions within the kidney tissue to better predict important clinical outcomes. Investigators aspire to establish a prospective, longitudinal cohort to improve the diagnosis and management of kidney transplant rejection using precision pathology. By utilising new spatial technologies, the investigators aim to: * Derive a spatially resolved transcriptomic signature of kidney transplant rejection subtypes * Derive accurate transcriptomic signatures aligned with key cell types within the transplant kidney * Develop refinements to histological kidney rejection diagnostic and scoring classification * Correlate of spatial and refined biopsy scoring features to clinically important outcomes

Подробное описание

Primary outcomes: The correlation of kidney transplant rejection subtypes with transcriptomic, spatial and cell-type features

Secondary outcomes: Correlation of the refined biopsy scoring criteria and transcriptomics signatures with:

1. All cause graft loss 2. Death censored graft loss 3. Treatment resistant rejection 4. Delayed graft function (DGF) 5. Biopsy evidence of borderline rejection based on current Banff scoring system 6. Biopsy proven acute rejection - T-cell mediated (TCMR), antibody-mediated (ABMR), mixed 7. Chronic rejection - acute or inactive 8. Interstitial fibrosis scores (IFTA) on kidney biopsy on any biopsies 9. Chronic transplant glomerulopathy on kidney biopsy on any biopsies 10. Development of BK virus associated nephropathy at any time 11. Recurrent disease (original cause of kidney failure) post transplantation at any time 12. Kidney function with serum creatinine, estimated or measured glomerular filtration rate (GFR) 13. Development of albuminuria 14. Surrogate end-points - eGFR slope and iBOX(TM) score 15. Donor-recipient HLA and non-HLA genomic mismatches 16. Recipient proteinomic expression profile

Вмешательства

Другое Non interventional
Non interventional. Review of clinical, biopsy (histopathological and molecular) features associated with rejection and non-rejection pathology diagnosis

Первичные конечные точки

Kidney biopsy features [Срок оценки: At biopsy or during study follow up following biopsy during study (expected 12-months)]
Kidney biopsy transcriptomic signature [Срок оценки: At biopsy - based on collected tissue sample]
Kidney cell type composition [Срок оценки: At biopsy - based on collected tissue sample]

Вторичные конечные точки (12)

All cause graft loss [Срок оценки: At biopsy or during study follow up after biopsy (expected average over 60-months)]
Death censored graft loss (DCGL) [Срок оценки: At biopsy or during study follow up after biopsy (expected average over 60-months)]
Treatment resistant rejection [Срок оценки: At biopsy or during study follow up after biopsy (expected average 12-months)]
Delayed graft function (DGF) [Срок оценки: At biopsy or during study follow up after biopsy (within 7 days of transplantation)]
Biopsy evidence of borderline rejection [Срок оценки: At biopsy or during study follow up after biopsy (expected average 12-months)]
Biopsy proven acute rejection [Срок оценки: At biopsy or during study follow up after biopsy (expected average 12-months)]
Chronic rejection [Срок оценки: At biopsy or during study follow up after biopsy (expected average 12-months)]
Interstitial fibrosis scores (IFTA) [Срок оценки: At biopsy or during study follow up after biopsy (expected average 12-months)]
BK virus associated nephropathy [Срок оценки: At biopsy or during study follow up after biopsy (expected average 12-months)]
Kidney function [Срок оценки: At biopsy or during study follow up after biopsy (expected average 12-months)]
Albuminuria [Срок оценки: At biopsy or during study follow up after biopsy (expected average 12-months)]
Surrogate end-points [Срок оценки: At biopsy or during study follow up after biopsy (expected average 12-months)]

Критерии участия

Критерии включения

All participants included in the study must be age ≥ 18 years old at time of enrolment and

able to provide informed consent (interpreter permitted) for enrolment
consenting to longitudinal follow up (can withdraw post enrolment)
consenting to provide samples for biobanking, including blood, urine, faecal and/or kidney biopsy tissue (collected prospectively, separate to routine care)