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Observational Study of Lung Transplant Rejection and Injury

This observational study is looking at new ways to detect rejection and injury in people who have received lung transplants. Researchers are studying how levels of donor-derived cell-free DNA (dd-cfDNA) in the blood relate to rejection. They are also using a new diagnostic system called Molecular Microscope® Diagnostic System (MMDx) to analyze biopsy samples. The goal is to improve how accurately and precisely rejection is identified, potentially making biopsies safer. The study aims to enroll 600 participants aged 18 and older who have had a lung transplant. Success will be measured by how well the Prospera® test can identify T cell mediated rejection, antibody-mediated rejection, and lung injury after 18 months. The current recruitment status is unclear.

Study design
This is an observational study, meaning researchers will watch and collect information without giving any specific treatments. It plans to include 600 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints for this study are measured at 18 months, suggesting participants will be followed for at least that long.

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NCT05837663

Trifecta-Lung cfDNA-MMDx Study

Recruiting
Not specifiedAges 18+Observational
University of Alberta
~600 participants
Updated 2026-07-17 on ClinicalTrials.gov

At a glance

Recruiting sites
17 of 19 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Calibration of Prospera® test for T cell mediated rejection
Measured over 18 months
+4 more outcomes measured

Conditions

Lung Transplantation

Explore related trials

Lung Transplantation

Where it's being run

19 sites across 12 states
Texas4
Florida3
Alberta2
Czechia2
Arizona1
Indiana1
Maryland1
New York1

Study leadership

  • Philip F Halloran, MD PhD · PRINCIPAL_INVESTIGATOR · Alberta Transplant Applied Genomics Centre, University of Alberta

Who to contact

Konrad S Famulski, PhD DSc
[email protected]
1 780 782 9463
Email the study team

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What this trial measures

  • Calibration of Prospera® test for T cell mediated rejection18 months

    Set dd-cfDNA test cut-off values against the probability of T cell-mediated rejection in the biopsy (TBB and 3BMB) as reported by MMDx. Calibration of dd-cfDNA test cut-off values against the probability of T cell-mediated rejection in the biopsy as reported by MMDx.

  • Calibration of Prospera® test for antibody-mediated rejection18 months

    Set dd-cfDNA test cut-off values against the probability of antibody-mediated rejection in the biopsy (TBB and 3BMB) as reported by MMDx.

  • Calibration of Prospera® test for lung injury18 months

    Set dd-cfDNA test cut-off values against the probability of acute and chronic lung injury in the biopsy (TBB and 3BMB)as reported by MMDx.

  • Report calibrated Prospera® test results for rejection6 months

    Report new dd-cfDNA test cut-off values for rejection

  • Report calibrated Prospera® test results for lung injury6 months

    Report new DD-cfDNA test cut-off values for lung injury