Diagnostic and Therapeutic Applications in Microarrays in Organ Transplantation
The current standard for biopsy-based diagnoses of dysfunction of kidney transplants is the Banff Classification which represents arbitrary international consensus. Recent data-driven approaches using molecular and conventional technologies indicate that mere consensus produces frequently incorrect diagnoses with potential harm to patients due to inappropriate treatment. To address this unmet need and improve diagnostics in the area of organ transplantation, the Alberta Transplant Applied Genomics Centre (ATAGC) has developed a new diagnostic system that combines the molecular and histopathological features of transplant biopsies, plus clinical and laboratory parameters, to create the first Integrated Diagnostic System. The present study will validate and refine this system in 500 prospectively unselected biopsies for clinical indications from American, Canadian and European centres. In addition to demonstrating the feasibility and value of this System in routine patient care and clinical trials, the study will develop and optimize a transparent and user-friendly reporting format to communicate this information to clinicians and obtain detailed feedback on how this system can best improve patient care.
To Validate the Integrated Diagnostic System in the International Collaborative Microarray (INTERCOM)
To Develop a Clinically Feasible and Useful Reporting System for Molecular, Histopathology and Integrated
To Incorporate the Integrated Diagnostic System Into International Diagnostic Standards
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Multi-centric Observational Study to Analyse the Diagnostic Molecular Features in the Clinical Setting of Kidney Allograft Biopsies|
Needle kidney biopsy core as per local standard of care
|Study Start Date:||May 2011|
Kidney Transplant Biopsies for Cause
The study population includes patients with a functioning kidney transplant undergoing a biopsy for clinical indications as standard of care to determine the cause of their graft dysfunction (deterioration in graft function, delayed graft function, proteinuria).
The study is now fully enrolled (N=300) and the results are being analyzed. Follow-up data is being collected.
|United States, Maryland|
|University of Maryland School of Medicine|
|Baltimore, Maryland, United States, 21209|
|United States, Minnesota|
|University of Minnesota|
|Minneapolis, Minnesota, United States, 55455|
|Hannover, Germany, 30625|
|Vall d'Hebron Hospital|
|Barcelona, Spain, 08035|
|Manchester Royal Infirmary|
|Manchester, United Kingdom, M13 9WL|