Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06505200
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-07-10
Brief Title:
Observational Cohort Study Renal Transplantation University Hospitals Leuven
Sponsor:
None
Organization:
None
Study Overview
Official Title:
An Integrative Clinicopathological Decision Support System for Kidney Transplant Rejection
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This retrospective observational cohort study aims to compile routinely collected clinical histological and outcome data of kidney transplant recipients to evaluate risk factors for post-transplant injury phenotypes of injury and impact on outcome of such injury in order to provide clinicians more accurate less biased and faster tools for diagnosis clinical management and treatment decisions with regard to kidney transplant rejection
Detailed Description:
The following datafeatures will be collected from the clinical charts
Demographics
Date of transplantation
Date of graft failure
Last date of follow-up
Time after transplantation of survival number of days
kidney survival
recipient death
recipient gender
recipient age at time of transplantation
recipient weight at time of transplantation
recipient BMI at time of transplantation
recipient race
recipient diabetes prior to transplantation
the Belgian Index for Multiple Deprivation BIMD
combined vs single transplant we included only single transplants
repeat transplant vs first transplant
diagnosis of the original kidney disease prior to transplantation
donor type living vs deceased
donor gender
donor age in years
donor diabetes yes vs no
HLA genotype of donors and recipients number of HLA A mismatches between donor and recipient 0-2 number of HLA B mismatches between donor and recipient 0-2 number of HLA DR mismatches between donor and recipient 0-2 number of total HLA mismatches between donor and recipient 0-6 high-resolution genotyping of donors and recipients HLA genes 11 loci
cold ischemia time
warm ischemia time
operation time
Graft functional data
Serum creatinine values from day of transplantation onwards
Proteinuria values from day of transplantation onwards
Data on DSA
DSA data collected in clinical routine from the day of listing for transplantation onwards clinically measured at the Histocompatibility laboratory of the Red Cross Motstraat Mechelen and reported in the clinical patient records
Biopsy data
Both clinically indicated and protocol biopsies were performed in this cohort On average 32 biopsies per patient
The following data will be collected from the clinical records and transferred to a pseudonymized database Date of the kidney biopsy Indication biopsy at time of graft dysfunction protocol prespecified biopsy per protocol pretransplant biopsy prior to transplantation in the donor post-transplant biopsy after transplantation time point indication vs Protocol biopsy time points tubulitis 0-3 interstitial inflammation 0-3 vasculitis 0-3 glomerulitis 0-3 peritubular capillaritis 0-3 thrombi 0-3 C4d deposition in peritubular capillaries 0-3 C4d deposition in glomerular capillaries 0-3 transplant glomerulopathy 0-3 interstitial fibrosis 0-3 tubular atrophy 0-3 vascular intimal thickening 0-3 mesangial matrix increase 0-3 arteriolar hyalinosis 0-3 glomerulosclerosis microcirculatory inflammation 0-6 g ptc diagnosis of antibody-mediated rejection yes vs no according to current international consensus calculated from g ptc cg thrombi C4d_ptc and v diagnosis of T-cell mediated rejection yes vs no according to current international consensus 0 absent 1 borderline 1present diagnosis of IFTA grade 0-3 according to current international consensus calculated from ci and ct
Next to pseudonymized clinical data also histological slides will be retrieved from the biobank of the Department of Pathology of the University Hospitals Leuven and whole slide images made available for image analysis
Demographics
Date of transplantation
Date of graft failure
Last date of follow-up
Time after transplantation of survival number of days
kidney survival
recipient death
recipient gender
recipient age at time of transplantation
recipient weight at time of transplantation
recipient BMI at time of transplantation
recipient race
recipient diabetes prior to transplantation
the Belgian Index for Multiple Deprivation BIMD
combined vs single transplant we included only single transplants
repeat transplant vs first transplant
diagnosis of the original kidney disease prior to transplantation
donor type living vs deceased
donor gender
donor age in years
donor diabetes yes vs no
HLA genotype of donors and recipients number of HLA A mismatches between donor and recipient 0-2 number of HLA B mismatches between donor and recipient 0-2 number of HLA DR mismatches between donor and recipient 0-2 number of total HLA mismatches between donor and recipient 0-6 high-resolution genotyping of donors and recipients HLA genes 11 loci
cold ischemia time
warm ischemia time
operation time
Graft functional data
Serum creatinine values from day of transplantation onwards
Proteinuria values from day of transplantation onwards
Data on DSA
DSA data collected in clinical routine from the day of listing for transplantation onwards clinically measured at the Histocompatibility laboratory of the Red Cross Motstraat Mechelen and reported in the clinical patient records
Biopsy data
Both clinically indicated and protocol biopsies were performed in this cohort On average 32 biopsies per patient
The following data will be collected from the clinical records and transferred to a pseudonymized database Date of the kidney biopsy Indication biopsy at time of graft dysfunction protocol prespecified biopsy per protocol pretransplant biopsy prior to transplantation in the donor post-transplant biopsy after transplantation time point indication vs Protocol biopsy time points tubulitis 0-3 interstitial inflammation 0-3 vasculitis 0-3 glomerulitis 0-3 peritubular capillaritis 0-3 thrombi 0-3 C4d deposition in peritubular capillaries 0-3 C4d deposition in glomerular capillaries 0-3 transplant glomerulopathy 0-3 interstitial fibrosis 0-3 tubular atrophy 0-3 vascular intimal thickening 0-3 mesangial matrix increase 0-3 arteriolar hyalinosis 0-3 glomerulosclerosis microcirculatory inflammation 0-6 g ptc diagnosis of antibody-mediated rejection yes vs no according to current international consensus calculated from g ptc cg thrombi C4d_ptc and v diagnosis of T-cell mediated rejection yes vs no according to current international consensus 0 absent 1 borderline 1present diagnosis of IFTA grade 0-3 according to current international consensus calculated from ci and ct
Next to pseudonymized clinical data also histological slides will be retrieved from the biobank of the Department of Pathology of the University Hospitals Leuven and whole slide images made available for image analysis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None