Using Microarray Technology to Improve Diagnosis and Treatment in Liver Transplant Patients A Multicenter Observational Study of Liver Transplant Biopsies

What this Trial Is About

Researchers are investigating the relationship between the molecular characteristics of liver transplant biopsies and their traditional histologic and clinical features. This observational study aims to improve the accuracy of diagnosing liver transplant dysfunction by adapting a new molecular diagnostic system called the Molecular Microscope4 Diagnostic System MMDx, which integrates molecular, histological, clinical, and laboratory data. The study is conducted by the University of Alberta and includes centers in North America and Europe. The study involves collecting liver transplant biopsy samples taken for clinical reasons or center protocols. These biopsies are analyzed to assign molecular scores indicating the likelihood of T cell mediated rejection or antibody mediated rejection. The project will develop and validate this molecular diagnostic approach using 300 biopsies and aims to provide results in real time within two working days after biopsy receipt. Participants contribute biopsy samples collected as part of their standard clinical care. The research team will analyze these samples for molecular markers related to transplant rejection and compare them to traditional biopsy findings. Results will be communicated to clinicians using a user-friendly reporting format. The primary outcome is to assign molecular probabilities of rejection within two years, with a secondary outcome to deliver these assessments promptly within one year. The study plans to collect up to 900 biopsies in total and follows participants over time to evaluate diagnostic performance.

Diagnostic and Therapeutic Applications of Microarrays in Liver Transplantation