Trifecta-Lung Study

Calibrating circulating donor-derived cell-free DNA against molecular biopsy assessments.

Investigators: Philip F Halloran, and the Trifecta-Lung Study Group (ClinicalTrials.gov NCT05837663)

Current screening methods for detecting rejection in lung transplant patients, particularly through histological assessment of transbronchial biopsies, face significant limitations. To enhance this process, the Alberta Transplant Applied Genomics Centre has developed the Molecular Microscope® Diagnostic System (MMDx)—a comprehensive molecular assessment tool for identifying rejection and chronic injury in lung biopsies based on gene expression.

We are excited to introduce a new screening test that monitors donor-derived cell-free DNA (dd-cfDNA) in blood, specifically the Natera, Inc. dd-cfDNA Prospera™ test. This study aims to calibrate dd-cfDNA levels detected at the time of indication or protocol biopsies against MMDx measurements for various types of rejection, including T-cell mediated rejection (TCMR), antibody-mediated rejection (ABMR) and its stages, as well as chronic injury.

We also want to determine whether dd-cfDNA blood test will avoid need for indication biopsy when transplant function deteriorates and if the dd-cfDNA test indicate the response to treatment.

Our research will compare blood dd-cfDNA measurements collected at the time of biopsies with MMDx results and will also assess HLA antibodies in blood samples. This study is an extension of the INTERLUNG project (ClinicalTrials.gov ID: NCT02812290) and is currently being conducted at  five centers across the US, Canada, Europe and Australia.

For more details, please click here: ClinicalTrials.gov NCT05837663