Actively Recruiting
Led by University of Alberta · Updated on 2026-06-04
300
Participants Needed
15
Research Sites
52 weeks
Total Duration
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.
CONDITIONS
Diagnostic and Therapeutic Applications of Microarrays in Liver Transplantation
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Ongoing as biopsies are performed
Participants undergo liver biopsy for clinical indication to obtain tissue for molecular and histopathological analysis.
1 biopsy procedure visit (in-person)
Duration - Up to 2 years
Participants are observed as their biopsy results are analyzed using the Molecular Microscope® Diagnostic System to improve diagnostic accuracy in liver transplantation.
Follow-up assessments as part of routine care; no additional study visits required
Total: 15 locations
1
University of California San Francisco, Transplant Research Unit
San Francisco, California, United States, 94143
Completed
2
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
Completed
3
University of Maryland School of Medicine
Baltimore, Maryland, United States, 21201
Completed
4
Henry Ford Transplant Institute
Detroit, Michigan, United States, 48202
Actively Recruiting
5
Vanderbilt University Medical Center, Vanderbilt Transplant Center
Nashville, Tennessee, United States, 37232
Withdrawn
6
Baylor University Medical Center, Annette C. and Harold C. Simmons Transplant Institute
Dallas, Texas, United States, 75246
Completed
7
Transplant Surgery, VCU Medical Center
Richmond, Virginia, United States, 23298
Completed
8
Division of Transplant Surgery, University of Washington
Seattle, Washington, United States, 98195
Completed
9
Centenary Institute of Cancer Medicine & Cell Biology, Royal Prince Alfred Hospital
Camperdown, Australia, NSW 2050
Completed
10
University of Alberta, Laboratory Medicine and Pathology
Edmonton, Alberta, Canada, T6G 2R7
Completed
11
Dep. of Nephrology, Transplantation & Internal Med., Samodzielny Publiczny Szpital Kliniczny im. A. Mieleckiego
Katowice, Poland, 40-027
Completed
12
Independent Public Composite Regional Hospital
Szczecin, Poland, 71-455
Completed
13
Warsaw Medical University, Jesus the Child Clinical Hospital
Warsaw, Poland, 02-005
Completed
14
Warsaw Medical University, Independent Public Clinical Hospital
Warsaw, Poland, 02-097
Completed
15
Institute for Liver Science, King's College London
London, United Kingdom, SE5 9NU
Completed
K
Konrad S Famulski, PhD
R
Robert Polakowski, PhD
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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