Using gene expression analysis to improve liver transplant diagnostics
Diagnostic and Therapeutic Applications of Microarrays in Liver Transplantation, a Multicenter Study
University of Alberta · NCT03193151
This study is testing a new way to check liver health after transplants by combining genetic information with traditional biopsy results to help doctors make better diagnoses for patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Alberta (other) |
| Locations | 15 sites (San Francisco, California and 14 other locations) |
| Trial ID | NCT03193151 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the relationship between the molecular and histological characteristics of liver transplant biopsies to enhance diagnostic accuracy. By utilizing the Molecular Microscope® Diagnostic System (MMDx), the study aims to integrate molecular and histopathological data with clinical parameters to create a comprehensive diagnostic tool. A total of 300 liver biopsies will be collected for analysis, focusing on improving the current standard of care which relies heavily on histology. The goal is to refine and validate this new diagnostic approach to better identify liver dysfunction in transplant patients.
Who should consider this trial
Good fit: Ideal candidates for this study are patients undergoing liver biopsies for clinical indications related to liver transplant dysfunction.
Not a fit: Patients who are pregnant or unable to provide consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate diagnoses of liver transplant dysfunction, potentially improving patient outcomes and treatment strategies.
How similar studies have performed: Previous studies using molecular diagnostics in other organ transplants have shown promise, indicating potential for success in this novel application for liver transplants.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * biopsy for clinical indications Exclusion Criteria: * no consent, pregnant women
Where this trial is running
San Francisco, California and 14 other locations
- University of California San Francisco, Transplant Research Unit — San Francisco, California, United States (COMPLETED)
- Northwestern Memorial Hospital — Chicago, Illinois, United States (COMPLETED)
- University of Maryland School of Medicine — Baltimore, Maryland, United States (COMPLETED)
- Henry Ford Transplant Institute — Detroit, Michigan, United States (RECRUITING)
- Vanderbilt University Medical Center, Vanderbilt Transplant Center — Nashville, Tennessee, United States (WITHDRAWN)
- Baylor University Medical Center, Annette C. and Harold C. Simmons Transplant Institute — Dallas, Texas, United States (COMPLETED)
- Transplant Surgery, VCU Medical Center — Richmond, Virginia, United States (COMPLETED)
- Division of Transplant Surgery, University of Washington — Seattle, Washington, United States (COMPLETED)
- Centenary Institute of Cancer Medicine & Cell Biology, Royal Prince Alfred Hospital — Camperdown, Australia (COMPLETED)
- University of Alberta, Laboratory Medicine and Pathology — Edmonton, Alberta, Canada (COMPLETED)
- Dep. of Nephrology, Transplantation & Internal Med., Samodzielny Publiczny Szpital Kliniczny im. A. Mieleckiego — Katowice, Poland (COMPLETED)
- Independent Public Composite Regional Hospital — Szczecin, Poland (COMPLETED)
- Warsaw Medical University, Jesus the Child Clinical Hospital — Warsaw, Poland (COMPLETED)
- Warsaw Medical University, Independent Public Clinical Hospital — Warsaw, Poland (COMPLETED)
- Institute for Liver Science, King's College London — London, United Kingdom (COMPLETED)
Study contacts
- Principal investigator: Philip F Halloran, MD, PhD — University of Alberta
- Study coordinator: Konrad S Famulski, PhD
- Email: konrad@ualberta.ca
- Phone: 1 780 492 1725
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Liver Dysfunction, Liver transplant, global gene expression, molecular diagnostics