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.

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NCT02812290

Diagnostic and Therapeutic Applications of Microarrays in Lung Transplantation

Recruiting
Not specifiedAges 18+Observational
University of Alberta
~700 participants
Updated 2026-05-28 on ClinicalTrials.gov
What's tested:Lung transplant biopsy bites.

At a glance

Recruiting sites
4 of 11 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Report the molecular scores (probability) of lung transplant disease in a reference set of 600 transbronchial biopsies.
Measured over two years
+1 more outcome measured
Lung Transplant Rejection
11 sites across 10 states
Alberta2
Arizona1
Maryland1
Missouri1
Texas1
Australia1
Austria1
Ontario1
  • Philip F Halloran, MD, PhD · PRINCIPAL_INVESTIGATOR · Faculty of Medicine and Dentistry, University of Alberta

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Eligibility criteria

Inclusion

All lung transplant recipients undergoing a biopsy as determined by their surgeon or physician.

Exclusion

Patients who declined participation or unable to give informed consent.
  • 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.