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Clinical Trials in Australia / NCT05837663
Recruiting Observational

Trifecta-Lung cfDNA-MMDx Study

NCT05837663 · tracked via the Priya Life Science Australia tracker
Sponsor
University of Alberta
Phase
Observational
Started
2023-11-01
Last updated
2026-07-17

Condition(s) studied

Lung Transplantation

Study summary

Demonstrate the relationship between dd-cfDNA levels and HLA antibodies in blood transplant recipient and Demonstrate the Molecular Microscope® (MMDx) Diagnostic System results in indication and protocol biopsies from lung transplants.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: Adult, Older adult Exclusion Criteria: Patients will be excluded from the study if they decline participation Are unable to give informed consent. Recipients of multiple organs, cancer patients and pregnant women

Primary outcome measure(s)

  • Calibration of Prospera® test for T cell mediated rejection — 18 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 rejection — 18 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 injury — 18 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 rejection — 6 months
    Report new dd-cfDNA test cut-off values for rejection
  • Report calibrated Prospera® test results for lung injury — 6 months
    Report new DD-cfDNA test cut-off values for lung injury

Trial sites (19)

FacilityCityRegionStatus
St. Joseph's Hospital and Medical Center 350 West Thomas Road, Floor 8HLT Phoenix Arizona Recruiting
Division of Pulmonary, Critical Care and Sleep Medicine, University of Florida, College of Medicine Gainesville Florida Recruiting
Mayo Clinic Florida, 4500 San Pablo Rd Jacksonville Florida Recruiting
USF Health, Morsani College of Medicine, 12901 Bruce B. Downs Blvd. MDC40 Tampa Florida Not Yet Recruiting
Indiana University Methodist Hospital 1812 N. Capitol Ave Suite W131L Indianapolis Indiana Recruiting
Johns Hopkins Interventional Pulmonology, Sheikh Zayed Tower, Room 7125L, 1800 Orleans Street Baltimore Maryland Recruiting
Division of Pulmonary, Allergy & Critical Care Medicine Columbia University Irving Medical Center New York New York Recruiting
The Ohio State University Wexner Medical Center, 410 W 10th Ave Columbus Ohio Recruiting
BAYLOR SCOTT & WHITE RESEARCH INSTITUTE , 3409 Worth Street Dallas Texas Recruiting
UT Southwestern Medical Center, 5939 Harry Hines Blvd. Dallas Texas Recruiting
Houston Methodist Lung Transplant Center, 6550 Fannin St., SM1001 Houston Texas Recruiting
UT Health San Antonio 7703 Floyd Curl Drive, MSC: 7858 San Antonio Texas Recruiting
The Alfred Hospital, Monash University Melbourne Australia Recruiting
Department of Thoracic Surgery, Medical University of Vienna Vienna Austria Not Yet Recruiting
Department of Medicine, University of Alberta Edmonton Alberta Recruiting
Alberta Transplant Applied Genomics Centre, University of Alberta Edmonton Alberta Recruiting
University Health Network, Toronto General Hospital Toronto Ontario Recruiting
Motol University Hospital, V Uvalu 84 Prague Czechia Recruiting
Charles University/Hospital Motol Prague Czechia Recruiting

More University of Alberta trials in Australia

Diagnostic and Therapeutic Applications of Microarrays in Lung Transplantation Recruiting
Trifecta-Heart cfDNA-MMDx Study Recruiting
Diagnostic and Therapeutic Applications of Microarrays in Liver Transplantation Recruiting
Lumbar Brace Deployment in the Emergency Department for Benign Low Back Pain Recruiting
Trifecta-Kidney cfDNA-MMDx Study Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05837663 on ClinicalTrials.gov ↗ ← All trials in Australia