Assessing blood tests for lung transplant rejection
Trifecta-Lung cfDNA-MMDx Study: Comparing the Dd-cfDNA Test to MMDx Microarray Test and Central HLA Antibody Test
This study is testing if new blood tests can help doctors better detect lung transplant rejection by comparing them to traditional biopsy methods.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Alberta Academic / other |
| Locations | 18 sites (Phoenix, Arizona and 17 other locations) |
| Trial ID | NCT05837663 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the relationship between donor-derived cell-free DNA (dd-cfDNA) levels and HLA antibodies in lung transplant recipients. It seeks to evaluate the effectiveness of the Molecular Microscope® Diagnostic System (MMDx) in analyzing biopsy samples and blood tests to improve the accuracy of rejection assessments. By comparing traditional biopsy methods with new blood tests, the study hopes to enhance patient safety and diagnostic precision in lung transplantation. The research will involve multiple institutions to gather comprehensive data on lung transplant outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are adult lung transplant recipients who can provide informed consent.
Not a fit: Patients who are unable to give informed consent, those with multiple organ transplants, cancer patients, and pregnant women may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate and less invasive methods for monitoring lung transplant rejection.
How similar studies have performed: Previous studies using similar approaches in kidney transplantation have shown promising results, indicating potential for success in lung transplantation as well.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Adult, Older adult Exclusion Criteria: Patients will be excluded from the study if they decline participation Are unable to give informed consent. Recipients of multiple organs, cancer patients and pregnant women
Where this trial is running
Phoenix, Arizona and 17 other locations
- St. Joseph's Hospital and Medical Center 350 West Thomas Road, Floor 8HLT — Phoenix, Arizona, United States (Recruiting)
- Division of Pulmonary, Critical Care and Sleep Medicine, University of Florida, College of Medicine — Gainesville, Florida, United States (Recruiting)
- USF Health, Morsani College of Medicine, 12901 Bruce B. Downs Blvd. MDC40 — Tampa, Florida, United States (Recruiting)
- Indiana University Methodist Hospital 1812 N. Capitol Ave Suite W131L — Indianapolis, Indiana, United States (Recruiting)
- Johns Hopkins Interventional Pulmonology, Sheikh Zayed Tower, Room 7125L, 1800 Orleans Street — Baltimore, Maryland, United States (Recruiting)
- Division of Pulmonary, Allergy & Critical Care Medicine Columbia University Irving Medical Center — New York, New York, United States (Recruiting)
- The Ohio State University Wexner Medical Center, 410 W 10th Ave — Columbus, Ohio, United States (Recruiting)
- BAYLOR SCOTT & WHITE RESEARCH INSTITUTE , 3409 Worth Street — Dallas, Texas, United States (Recruiting)
- UT Southwestern Medical Center, 5939 Harry Hines Blvd. — Dallas, Texas, United States (Recruiting)
- Houston Methodist Lung Transplant Center, 6550 Fannin St., SM1001 — Houston, Texas, United States (Recruiting)
- UT Health San Antonio 7703 Floyd Curl Drive, MSC: 7858 — San Antonio, Texas, United States (Recruiting)
- The Alfred Hospital, Monash University — Melbourne, Australia (Recruiting)
- Department of Thoracic Surgery, Medical University of Vienna — Vienna, Austria (Not_yet_recruiting)
- Department of Medicine, University of Alberta — Edmonton, Alberta, Canada (Recruiting)
- Alberta Transplant Applied Genomics Centre, University of Alberta — Edmonton, Alberta, Canada (Recruiting)
- University Health Network, Toronto General Hospital — Toronto, Ontario, Canada (Recruiting)
- Motol University Hospital, V Uvalu 84 — Prague, Czechia (Recruiting)
- Charles University/Hospital Motol — Prague, Czechia (Recruiting)
Study contacts
- Principal investigator: Philip F Halloran, MD PhD — Alberta Transplant Applied Genomics Centre, University of Alberta
- Study coordinator: Konrad S Famulski, PhD DSc
- Email: konrad@ualberta.ca
- Phone: 1 780 782 9463
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.