Evaluating new diagnostic methods for lung transplant rejection
Multi-Centric Observational Study to Analyze the Diagnostic Molecular Features in the Clinical Setting of Lung Allograft Biopsies
This study is testing a new diagnostic tool to see if it can better identify lung transplant rejection in patients who are having problems with their transplanted lungs.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 700 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Alberta Academic / other |
| Locations | 11 sites (Phoenix, Arizona and 10 other locations) |
| Trial ID | NCT02812290 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the effectiveness of a new diagnostic system, the Molecular Microscope® Diagnostic System (MMDx), for evaluating lung transplant biopsies in patients experiencing allograft dysfunction. It compares molecular phenotyping of transbronchial biopsies with traditional diagnostic methods to improve accuracy in diagnosing lung transplant rejection. The study will involve 300 lung transplant recipients undergoing biopsies, with a focus on refining the MMDx system for better patient outcomes. The research is being conducted at multiple institutions, including the University of Alberta and other prominent medical centers.
Who should consider this trial
Good fit: Ideal candidates for this study are lung transplant recipients who are undergoing a biopsy as determined by their healthcare provider.
Not a fit: Patients who have declined 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 of lung transplant rejection, resulting in better treatment decisions and improved patient outcomes.
How similar studies have performed: Other studies have shown success in using molecular phenotyping for kidney transplants, suggesting potential for similar advancements in lung transplantation diagnostics.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All lung transplant recipients undergoing a biopsy as determined by their surgeon or physician. Exclusion Criteria: * Patients who declined participation or unable to give informed consent.
Where this trial is running
Phoenix, Arizona and 10 other locations
- St. Joseph's Hospital and Medical Center 350 West Thomas Road, Floor 8HLT — Phoenix, Arizona, United States (Recruiting)
- University of Maryland School of Medicine — Baltimore, Maryland, United States (Completed)
- Division of Pulmonary and Critical Care, Washington University School of Medicine — St Louis, Missouri, United States (Completed)
- University of Texas at San Antonio — San Antonio, Texas, United States (Completed)
- The Alfred Hospital, Monash University — Melbourne, Australia (Completed)
- Department of Thoracic Surgery, Medical University of Vienna — Vienna, Austria (Completed)
- Alberta Transplant Applied Genomics Centre, University of Alberta — Edmonton, Alberta, Canada (Recruiting)
- Department of Medicine, University of Alberta — Edmonton, Alberta, Canada (Recruiting)
- University Health Network, Toronto General Hospital — Toronto, Ontario, Canada (Completed)
- Charles University/Hospital Motol — Prague, Czechia (Recruiting)
- Thoracic Surgery Transplant Clinic — Szczecin, Poland (Completed)
Study contacts
- Principal investigator: Philip F Halloran, MD, PhD — Faculty of Medicine and Dentistry, University of Alberta
- Study coordinator: Konrad S Famulski, PhD
- Email: konrad@ualberta.ca
- Phone: 1 780 492 1725
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.