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Clinical Trials in Spain / NCT01299168
Recruiting Observational

Diagnostic and Therapeutic Applications in Microarrays in Organ Transplantation

NCT01299168 · tracked via the Priya Life Science Spain tracker
Sponsor
University of Alberta
Phase
Observational
Started
2011-05
Last updated
2026-06-02

Condition(s) studied

Validation Study of Molecular Diagnostic SystemDevelopment of Reporting System for Molecular DiagnosisIncorporate Molecular Diagnosis Into Diagnostic Standards

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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. Exclusion Criteria: * Patients will be excluded from the study if they decline participation or are unable to give informed consent.

Primary outcome measure(s)

Trial sites (26)

FacilityCityRegionStatus
University of Alabama Birmingham Alabama Completed
University of Maryland School of Medicine Baltimore Maryland Completed
University of Michigan Health System Ann Arbor Michigan Completed
University of Minnesota Minneapolis Minnesota Completed
Barnes-Jewish Hospital St Louis Missouri Completed
Montefiore Medical Center The Bronx New York Completed
Pinnacle Transplant Associates Harrisburg Pennsylvania Completed
Texas Transplant Institute - Methodist Healthcare System San Antonio Texas Completed
Virginia Commonwealth University School of Medicine Richmond Virginia Completed
University of Wisconsin School of Medicine and Public Health Madison Wisconsin Completed
Medical University of Vienna Vienna Austria Recruiting
Department of Medicine, University of Alberta Edmonton Alberta Recruiting
University of British Columbia, St. Paul's Hospital Vancouver British Columbia Withdrawn
University Hospital Merkur Zagreb Croatia Completed
Institute for Experimental and Clinical Medicine (IKEM) Prague Czechia Recruiting
Hopital Necker Paris France Completed
Hopital St. Louis Paris France Completed
Charité - Universitätmedizin Berlin Berlin Germany Completed
Medizinische Hochschule Hanover Germany Completed
Beaumont Hospital Dublin Ireland Withdrawn
Pomeranian Medical University in Szczecin Szczecin Poland Completed
University of Ljubljana Ljubljana Slovenia Completed
Department of Surgery, University of Usan, College of Medicine Seoul South Korea Completed
Vall d'Hebron Hospital Barcelona Spain Completed
University Hospital Zurich Zurich Switzerland Completed
Manchester Royal Infirmary Manchester United Kingdom Completed

More University of Alberta trials in Spain

Diagnostic and Therapeutic Applications of Microarrays in Heart Transplantation Recruiting
Screening for Prostate Cancer Using High Resolution Micro-ultrasound Versus Multiparametric Magnetic Resonance Imaging. Recruiting
Trifecta-Heart cfDNA-MMDx Study Recruiting
30% or 60% Oxygen at Birth to Improve Neurodevelopmental Outcomes in Very Low Birthweight Infants Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT01299168 on ClinicalTrials.gov ↗ ← All trials in Spain