Diagnostic and Therapeutic Applications of Microarrays in Liver Transplantation (INTERLIVER)
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ClinicalTrials.gov Identifier: NCT03193151 |
Recruitment Status :
Recruiting
First Posted : June 20, 2017
Last Update Posted : November 27, 2020
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Condition or disease | Intervention/treatment |
---|---|
Liver Dysfunction | Procedure: liver biopsy |
The current standard for biopsy-based diagnoses of dysfunction of liver transplants is histology (the Banff system), an arbitrary international empirical consensus based on lesions and rules, similar in principle to the kidney, heart, and lung histology systems. Recent data-driven approaches using molecular and conventional technologies indicate that such systems frequently produce incorrect diagnoses - perhaps 40-50% in abnormal kidney or heart transplant biopsies and even more in lung biopsies, with great potential for harm to patients due to inappropriate treatment.
To address this unmet need and improve diagnostics in the area of organ transplantation, the Alberta Transplant Applied Genomics Centre (ATAGC, University of Alberta) has developed a new diagnostic system - the Molecular Microscope® Diagnostic System (MMDx) that interprets biopsies in terms of their molecular phenotype, and combines the molecular and histopathological features of transplant biopsies, plus clinical and laboratory parameters, to create the first Integrated Diagnostic System. The MMDx, developed first in kidney transplant biopsies because phenotypes are well established, will now be adapted to liver transplant biopsies. The present study will develop a Reference Set of liver biopsies, adapt the MMDx system to assess and report molecular phenotype of liver biopsies; and validate and refine this system in 300 unselected prospectively collected for clinical indications and a standard of care biopsies from North American and European Centers. In addition to demonstrating the real-time feasibility and potential value of this System in patient care, the study will develop and optimize a transparent and user-friendly reporting format to communicate this information to clinicians and obtain detailed feedback to improve its utility.
Thanks to increasing interest and support from participating centers, INTERLIVER has already processed 509 biopsies from 455 participants.
Study Type : | Observational |
Estimated Enrollment : | 300 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Diagnostic and Therapeutic Applications of Microarrays in Liver Transplantation, a Multicenter Study |
Actual Study Start Date : | December 19, 2017 |
Estimated Primary Completion Date : | December 2022 |
Estimated Study Completion Date : | December 2023 |

- Procedure: liver biopsy
5 mm fragment of liver transplant biopsy taken for clinical indication
- Assign molecular scores (probability) of T cell mediated rejection, antibody mediated rejection in liver transplant biopsies, in a reference set of 100 biopsies [ Time Frame: two years ]Based on the reference set, create molecular classifier that predicts antibody mediated and T cell mediated rejection for next 200 biopsies
- Assign in real time (two working days upon biopsy receipt) molecular scores (probability) of T cell mediated rejection and antibody mediated rejection. [ Time Frame: 1 year ]The molecular phenotype of a newly acquired sample predicts the histologic and clinical features of this sample when compared to the reference set.
Biospecimen Retention: Samples Without DNA

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- biopsy for clinical indications
Exclusion Criteria:
- no consent, pregnant women

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03193151
Contact: Konrad S Famulski, PhD | 1 780 492 1725 | konrad@ualberta.ca | |
Contact: Robert Polakowski, PhD | 1 780 492 5091 | polakows@ualberta.ca |
United States, California | |
University of California San Francisco, Transplant Research Unit | Recruiting |
San Francisco, California, United States, 94143 | |
Contact: Monique Koenisberg 415-502-3016 Monique.Koenigsberg@ucsf.edu | |
Principal Investigator: Sandy Feng, MD, PhD | |
United States, Maryland | |
University of Maryland School of Medicine | Recruiting |
Baltimore, Maryland, United States, 21201 | |
Contact: Mariela Pinedo, MPH mpinedo@SOM.umaryland.edu | |
Principal Investigator: Stephen Gray | |
United States, Michigan | |
Henry Ford Transplant Institute | Recruiting |
Detroit, Michigan, United States, 48202 | |
Contact: Dilip Moonka, MD DMOONKA1@hfhs.org | |
Contact: Sierra Foley SFoley3@hfhs.org | |
Principal Investigator: Marwan Abouljoud, MD | |
United States, Tennessee | |
Vanderbilt University Medical Center, Vanderbilt Transplant Center | Not yet recruiting |
Nashville, Tennessee, United States, 37232 | |
Contact: Roman Perri, MD 615-343-2735 seth.karp@vanderbilt.edu | |
Principal Investigator: Seth J Karp, MD, PhD | |
Sub-Investigator: Roman Perri, MD | |
United States, Texas | |
Baylor University Medical Center, Annette C. and Harold C. Simmons Transplant Institute | Recruiting |
Dallas, Texas, United States, 75246 | |
Contact: Asrani Sumeet, MD Sumeet.Asrani@bswhealth.org | |
Principal Investigator: Goran Klintmalm, MD PhD | |
Sub-Investigator: Amar Gupta, MD | |
United States, Virginia | |
Transplant Surgery, VCU Medical Center | Recruiting |
Richmond, Virginia, United States, 23298 | |
Contact: Mary Baldecchi 804-502-3895 mary.baldecchi@vcuhealth.org | |
Contact: Tyler Wilkinson Tyler.Wilkinson@vcuhealth.org | |
Principal Investigator: Chandra Bhatti, MD | |
United States, Washington | |
Division of Transplant Surgery, University of Washington | Recruiting |
Seattle, Washington, United States, 98195 | |
Contact: Catherine I Kling, MD MPH 206-598-3753 cekling@uw.edu | |
Principal Investigator: Jorge Reyes, MD | |
Australia | |
Centenary Institute of Cancer Medicine & Cell Biology, Royal Prince Alfred Hospital | Recruiting |
Camperdown, Australia, NSW 2050 | |
Contact: Geoffrey McCaughan, MD, PhD 61-2-9565-6125 g.mccaughan@centenary.org.au | |
Contact: Tatiana Tsoutsman tatiana.Tsoutsman@healthnsw.gov.au | |
Principal Investigator: Geoffrey McCaughan | |
Canada, Alberta | |
University of Alberta, Laboratory Medicine and Pathology | Recruiting |
Edmonton, Alberta, Canada, T6G 2R7 | |
Contact: Aldo J Montano-Losa, MD PhD 780 248 1892 aldomontano-loza@med.ualberta.ca | |
Principal Investigator: Aldo J Montano-Losa, MD PhD | |
Sub-Investigator: Vince Bain, MD PhD | |
Poland | |
Dep. of Nephrology, Transplantation & Internal Med., Samodzielny Publiczny Szpital Kliniczny im. A. Mieleckiego | Recruiting |
Katowice, Poland, 40-027 | |
Contact: Grzegorz Piecha, MD (+48 79 289 0054 g.piecha@outlook.com | |
Principal Investigator: Grzegorz Piecha, MD | |
Independent Public Composite Regional Hospital | Recruiting |
Szczecin, Poland, 71-455 | |
Contact: Marek Myslak, MD PhD m.myslak@mobicom.pl | |
Principal Investigator: Marta Marta Wawrzynowicz-Syczewska, Professor | |
Sub-Investigator: Samir Zeair, MD PhD | |
Warsaw Medical University, Jesus the Child Clinical Hospital | Recruiting |
Warszawa, Poland, 02-005 | |
Contact: Agnieszka Perkowska-Ptasinska, MD, PhD aggape@poczta.onet.pl | |
Contact: Olga Tronina olga.tronina@wcem.edu.pl | |
Principal Investigator: Agnieszka Perkowska-Ptasinska, MD, PhD | |
Sub-Investigator: Marek Pacholczyk, MD, PhD | |
Warsaw Medical University, Independent Public Clinical Hospital | Recruiting |
Warszawa, Poland, 02-097 | |
Contact: Krzysztof Zieniewicz, MD PhD krzysztof.zieniewicz@wum.edu.pl | |
Principal Investigator: Krzysztof Zieniewicz, MD, PhD | |
Sub-Investigator: Michal Grat, MD PhD | |
Sub-Investigator: Maciej Krasnodebski, MD | |
United Kingdom | |
Institute for Liver Science, King's College London | Recruiting |
London, United Kingdom, SE5 9NU | |
Contact: Alberto Sanchez-Fueyo, Professor sanchez_fueyo@kcl.ac.uk | |
Principal Investigator: Alberto Sanchez-Fueyo, MD, PhD |
Principal Investigator: | Philip F Halloran, MD, PhD | University of Alberta |
Responsible Party: | Philip Halloran, Distinguished Professor, University of Alberta |
ClinicalTrials.gov Identifier: | NCT03193151 |
Other Study ID Numbers: |
ATAGC04 |
First Posted: | June 20, 2017 Key Record Dates |
Last Update Posted: | November 27, 2020 |
Last Verified: | November 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Liver transplant global gene expression molecular diagnostics |
Liver Diseases Digestive System Diseases |