Improving kidney transplant diagnosis using molecular techniques
Multi-centric Observational Study to Analyse the Diagnostic Molecular Features in the Clinical Setting of Kidney Allograft Biopsies
This study is testing a new way to diagnose kidney transplant issues by combining advanced lab techniques with patient information to see if it can provide more accurate results for better care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Alberta Academic / other |
| Locations | 26 sites (Birmingham, Alabama and 25 other locations) |
| Trial ID | NCT01299168 on ClinicalTrials.gov |
What this trial studies
This study aims to validate a new diagnostic system that integrates molecular and histopathological features of kidney transplant biopsies with clinical and laboratory parameters. The Alberta Transplant Applied Genomics Centre has developed this Integrated Diagnostic System to address the limitations of the current Banff Classification, which often leads to incorrect diagnoses. The study will analyze 500 prospectively collected biopsies from various centers in North America and Europe, in addition to 300 previously collected samples. By refining this system, the study seeks to enhance the accuracy of kidney transplant diagnostics and improve patient outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are kidney transplant recipients aged 18 years and older who are undergoing a biopsy for clinical reasons.
Not a fit: Patients who decline participation or are unable to provide informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate diagnoses and better treatment decisions for kidney transplant recipients.
How similar studies have performed: Other studies have shown promise in using molecular diagnostic approaches in organ transplantation, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Birmingham, Alabama and 25 other locations
- 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)
- University of British Columbia, St. Paul's Hospital — Vancouver, British Columbia, Canada (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)
Study contacts
- Principal investigator: Philip F Halloran, MD PhD — University of Alberta
- Study coordinator: Philip F Halloran, MD PhD
- Email: phallora@ualberta.ca
- Phone: 1 780 492-6160
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.