Observational Study of MMDx System for Lung Transplant Rejection
This study is looking at a new way to diagnose problems in lung transplant recipients called the Molecular Microscope® Diagnostic System (MMDx). This system uses microarray analysis of lung transplant biopsy samples to understand the molecular makeup of the tissue. The goal is to see if MMDx can provide more accurate diagnoses than the current standard method, especially for chronic lung allograft dysfunction (CLAD), which is a common and serious issue after a lung transplant. You can join this study if you are an adult lung transplant recipient undergoing a biopsy as decided by your doctor. The researchers will measure the molecular scores and diagnoses from the MMDx system over two years to see how well it works. The study aims to enroll 700 participants.
- Study design
- This is an observational study, meaning researchers will collect information without giving new treatments. It plans to include 700 participants.
- What's involved
- You would undergo a lung transplant biopsy as determined by your surgeon or physician. In a second phase, two biopsy samples from the same patient will be collected.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will report molecular scores and diagnoses measured at two years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Diagnostic and Therapeutic Applications of Microarrays in Lung Transplantation
At a glance
Conditions
Where it's being run
11 sites across 10 statesStudy leadership
- Philip F Halloran, MD, PhD · PRINCIPAL_INVESTIGATOR · Faculty of Medicine and Dentistry, University of Alberta
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Inclusion
Exclusion
What this trial measures
- Report the molecular scores (probability) of lung transplant disease in a reference set of 600 transbronchial biopsies.two years
Molecular classifier predicts antibody mediated and T cell mediated rejection, and chronic allograft dysfunction.
- Report the molecular diagnoses of the MMDx-TBB systemtwo years
Compare MMDx readings to standard-of-care TBB histology and clinical diagnosis of CLAD.