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Само по покана NCT06288425

Spatial Transcriptomics in Kidney Transplantation

Заболявания: Transplant Complication Kidney Injury

Спонсор: Western Sydney Local Health District

Налично на: БГ
Обобщение
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
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
Кой може да участва
Inclusion Criteria: All participants included in the study must be age ≥ 18 years old at time of enrolment and 1. able to provide informed consent (interpreter permitted) for enrolment 2. consenting to longitudinal follow up (can withdraw post enrolment) 3. consenting to provide samples for biobanking, including blood, urine, faecal and/or kidney biopsy tissue (collected prospectively, separate to routine care) Exclusion Criteria: Patients will be excluded from the study if they are 1. unable (or unwilling) to provide consent, or 2. have life-expectancy less than 6-months, or 3. have received a haematopoietic stem cell transplant in the past 5 years.
Места на провеждане 1
Австралия (1)
Westmead Hospital
Westmead , New South Wales
Технически детайли
Статус
Само по покана
Вид изследване
OBSERVATIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Максимална възраст
75 Years
Здрави доброволци
Не
Начална дата
03.04.2024
Крайна дата
01.01.2035
Регистрационен номер
NCT06288425
Източник
anzctr
Запитване за медицински туризъм

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