Observational Study Using Molecular Analysis of Lung Transplant Biopsies to Improve Diagnosis and Treatment

What this Trial Is About

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.

Diagnostic and Therapeutic Applications of Microarrays in Lung Transplantation