Condition: Validation Study of Molecular Diagnostic System · Development of Reporting System for Molecular Diagnosis · Incorporate Molecular Diagnosis Into Diagnostic Standards · Sponsor: University of Alberta
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 300 biopsies already collected. Due to a considerable interest and support from participating Centers, the study is further extended to 1500 prospective biopsies. Thus this is the extension of the INTERCOM study (INTERCOMEX). 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.
This description comes directly from the study's public registry record.
Philip F Halloran, MD PhD · 1 780 492-6160 · phallora@ualberta.ca
Konrad S Famulski, PhD DSc · 1 780 4921725 · konrad@ualberta.ca
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| University of Alabama | Birmingham, Alabama, United States | Completed |
| University of Maryland School of Medicine | Baltimore, Maryland, United States | Completed |
| University of Michigan Health System | Ann Arbor, Michigan, United States | Completed |
| University of Minnesota | Minneapolis, Minnesota, United States | Completed |
| Barnes-Jewish Hospital | St Louis, Missouri, United States | Completed |
| Montefiore Medical Center | The Bronx, New York, United States | Completed |
| Pinnacle Transplant Associates | Harrisburg, Pennsylvania, United States | Completed |
| Texas Transplant Institute - Methodist Healthcare System | San Antonio, Texas, United States | Completed |
| Virginia Commonwealth University School of Medicine | Richmond, Virginia, United States | Completed |
| University of Wisconsin School of Medicine and Public Health | Madison, Wisconsin, United States | Completed |
| Medical University of Vienna | Vienna, Austria | Recruiting |
| Department of Medicine, University of Alberta | Edmonton, Alberta, Canada | Recruiting |
+ 14 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT01299168