RecruitingNCT05837663

Trifecta-Lung cfDNA-MMDx Study

Trifecta-Lung cfDNA-MMDx Study: Comparing the Dd-cfDNA Test to MMDx Microarray Test and Central HLA Antibody Test

Sponsor

University of Alberta

Enrollment

600 participants

Start Date

Nov 1, 2023

Study Type

OBSERVATIONAL

Conditions

Lung transplantation

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

The Trifecta-Lung study uses cell-free DNA (cfDNA) analysis — a cutting-edge liquid biopsy technique — combined with molecular microscopy (MMDx) of biopsy tissue to detect and characterize rejection episodes in lung transplant recipients. After a lung transplant, the immune system may attack the new organ in ways that are subtle and not easily detectable with conventional methods. cfDNA from the donor lung circulates in the recipient's blood when cells are being damaged; measuring it may allow earlier and more accurate detection of rejection than current standard tests. Adult and older adult lung transplant recipients who are willing to provide informed consent are eligible. Multiple organ transplant recipients, cancer patients, and pregnant women are excluded. Those who decline participation or cannot give consent are also excluded. Chronic lung allograft dysfunction (CLAD) — a form of long-term rejection — is the main cause of death after the first year in lung transplant patients, with five-year survival rates of only about 55%. Detecting rejection earlier and more accurately could enable timely treatment changes that preserve graft function and extend life. If validated, combining cfDNA monitoring with molecular biopsy analysis could become a standard surveillance tool that dramatically improves long-term outcomes after lung transplantation.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(18)

St. Joseph's Hospital and Medical Center 350 West Thomas Road, Floor 8HLT

Phoenix, Arizona, United States

Division of Pulmonary, Critical Care and Sleep Medicine, University of Florida, College of Medicine

Gainesville, Florida, United States

USF Health, Morsani College of Medicine, 12901 Bruce B. Downs Blvd. MDC40

Tampa, Florida, United States

Indiana University Methodist Hospital 1812 N. Capitol Ave Suite W131L

Indianapolis, Indiana, United States

Johns Hopkins Interventional Pulmonology, Sheikh Zayed Tower, Room 7125L, 1800 Orleans Street

Baltimore, Maryland, United States

Division of Pulmonary, Allergy & Critical Care Medicine Columbia University Irving Medical Center

New York, New York, United States

The Ohio State University Wexner Medical Center, 410 W 10th Ave

Columbus, Ohio, United States

BAYLOR SCOTT & WHITE RESEARCH INSTITUTE , 3409 Worth Street

Dallas, Texas, United States

UT Southwestern Medical Center, 5939 Harry Hines Blvd.

Dallas, Texas, United States

Houston Methodist Lung Transplant Center, 6550 Fannin St., SM1001

Houston, Texas, United States

UT Health San Antonio 7703 Floyd Curl Drive, MSC: 7858

San Antonio, Texas, United States

The Alfred Hospital, Monash University

Melbourne, Australia

Department of Thoracic Surgery, Medical University of Vienna

Vienna, Austria

Department of Medicine, University of Alberta

Edmonton, Alberta, Canada

Alberta Transplant Applied Genomics Centre, University of Alberta

Edmonton, Alberta, Canada

University Health Network, Toronto General Hospital

Toronto, Ontario, Canada

Motol University Hospital, V Uvalu 84

Prague, Czechia

Charles University/Hospital Motol

Prague, Czechia

View Full Details on ClinicalTrials.gov

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