Actively Recruiting
Led by University of Alberta · Updated on 2026-05-28
700
Participants Needed
11
Research Sites
26 weeks
Total Duration
Researchers are evaluating the potential benefits of molecular phenotyping of transbronchial biopsies in lung transplant recipients experiencing allograft dysfunction. The study aims to improve diagnostic accuracy compared to the current International Society of Heart and Lung Transplantation (ISHLT) biopsy classification, which can sometimes lead to incorrect diagnoses and inappropriate treatments. This research includes validating the Molecular Microscope Diagnostic System (MMDx), originally developed for kidney transplants, for use in lung transplants. The study involves analyzing lung transplant biopsy samples using the MMDx system and comparing these molecular assessments with conventional clinical, physiological, radiographic, and histological evaluations. Researchers will prospectively collect and study 300 transbronchial biopsies (TBBs) and test a safer biopsy method called third bifurcation mucosal endobronchial biopsies (3BMBs) in 50 patients to see if it can replace TBBs for molecular diagnostics. The study has been extended to include over 1,000 TBBs and 600 3BMBs from 849 patients. Participants will undergo biopsies as part of their routine medical care. The study will measure molecular scores and diagnoses from these biopsies using the MMDx system over a two-year period. Additional assessments will include tracking molecular changes over time with follow-up biopsies. This observational study does not involve treatment assignment but focuses on collecting and analyzing biopsy samples to enhance lung transplant diagnosis and care.
CONDITIONS
Diagnostic and Therapeutic Applications of Microarrays in Lung Transplantation
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years
Participants undergo lung transplant biopsies including transbronchial biopsies (TBBs) and mucosal endobronchial biopsies (3BMBs) to collect tissue samples for molecular and conventional diagnostic analysis.
Biopsy visits as determined by treating physician, including medically indicated follow-up biopsies
Duration - Up to 2 years
Participants are observed over time as molecular scores and diagnoses from biopsy analyses are reported and compared.
Follow-up visits for biopsy collection and assessment as clinically indicated
Total: 11 locations
1
St. Joseph's Hospital and Medical Center 350 West Thomas Road, Floor 8HLT
Phoenix, Arizona, United States, 85013
Actively Recruiting
2
University of Maryland School of Medicine
Baltimore, Maryland, United States, 21201
Completed
3
Division of Pulmonary and Critical Care, Washington University School of Medicine
St Louis, Missouri, United States, 63110
Completed
4
University of Texas at San Antonio
San Antonio, Texas, United States, 21201
Completed
5
The Alfred Hospital, Monash University
Melbourne, Australia
Completed
6
Department of Thoracic Surgery, Medical University of Vienna
Vienna, Austria
Completed
7
Alberta Transplant Applied Genomics Centre, University of Alberta
Edmonton, Alberta, Canada, T6G 2E1
Actively Recruiting
8
Department of Medicine, University of Alberta
Edmonton, Alberta, Canada, T6G 2G3
Actively Recruiting
9
University Health Network, Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4
Completed
10
Charles University/Hospital Motol
Prague, Czechia
Actively Recruiting
11
Thoracic Surgery Transplant Clinic
Szczecin, Poland, 70891
Completed
K
Konrad S Famulski, PhD
R
Robert Polakowski, PhD
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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