Diagnostic and Therapeutic Applications in Microarrays in Organ Transplantation
Recruiting now
Conditions studied: Validation Study of Molecular Diagnostic System, Development of Reporting System for Molecular Diagnosis, Incorporate Molecular Diagnosis Into Diagnostic Standards
In brief
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.
Key facts
- Study ID
- NCT01299168
- Run by
- University of Alberta
- People needed
- 500
- Starts
- 2011-05-01
- Expected to finish
- 2028-06-01
- Last updated by the study team
- 2026-06-02
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- All kidney transplant recipients ≥18yrs of age undergoing a kidney biopsy for clinical indications, as determined by their physician or surgeon, will be eligible to enrol in the study.
You may not qualify if…
- Patients will be excluded from the study if they decline participation or are unable to give informed consent.
Where it is running
- Institute for Experimental and Clinical Medicine (IKEM) — Prague, Czechia (enrolling)
- Medical University of Vienna — Vienna, Austria (enrolling)
- Department of Medicine, University of Alberta — Edmonton, Alberta, Canada (enrolling)
- University of Minnesota — Minneapolis, Minnesota, United States
- Barnes-Jewish Hospital — St Louis, Missouri, United States
- Montefiore Medical Center — The Bronx, New York, United States
- Pinnacle Transplant Associates — Harrisburg, Pennsylvania, United States
- Texas Transplant Institute - Methodist Healthcare System — San Antonio, Texas, United States
- Virginia Commonwealth University School of Medicine — Richmond, Virginia, United States
- University of Wisconsin School of Medicine and Public Health — Madison, Wisconsin, United States
- University of British Columbia, St. Paul's Hospital — Vancouver, British Columbia, Canada
- University Hospital Merkur — Zagreb, Croatia
- Hopital Necker — Paris, France
- Hopital St. Louis — Paris, France
- Charité - Universitätmedizin Berlin — Berlin, Germany
- Medizinische Hochschule — Hanover, Germany
- Beaumont Hospital — Dublin, Ireland
- Pomeranian Medical University in Szczecin — Szczecin, Poland
- University of Ljubljana — Ljubljana, Slovenia
- Department of Surgery, University of Usan, College of Medicine — Seoul, South Korea
- Vall d'Hebron Hospital — Barcelona, Spain
- University Hospital Zurich — Zurich, Switzerland
- University of Alabama — Birmingham, Alabama, United States
- Manchester Royal Infirmary — Manchester, United Kingdom
- University of Maryland School of Medicine — Baltimore, Maryland, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.