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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 : June 21, 2019
Sponsor:
Information provided by (Responsible Party):
Philip Halloran, University of Alberta

Brief Summary:
INTERLIVER is a prospective observational study of the relationship of the molecular phenotype of 300 liver transplant biopsies to the histologic phenotype and the clinical features and outcomes. A segment of a biopsy performed as standard-of-care for indications, or by center protocol, will be used for gene expression study.

Condition or disease Intervention/treatment
Liver Dysfunction Procedure: liver biopsy

Detailed Description:

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.


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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 : August 2020
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine



Intervention Details:
  • Procedure: liver biopsy
    5 mm fragment of liver transplant biopsy taken for clinical indication


Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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
Biopsy extract containing RNA


Information from the National Library of Medicine

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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
Study Population
This study aims to recruit 300 biopsies from liver transplant patients for clinical indications and the standard of care biopsies.
Criteria

Inclusion Criteria:

  • biopsy for clinical indications

Exclusion Criteria:

  • no consent, pregnant women

Information from the National Library of Medicine

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


Contacts
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Contact: Konrad S Famulski, PhD 1 780 492 1725 konrad@ualberta.ca
Contact: Robert Polakowski, PhD 1 780 492 5091 polakows@ualberta.ca

Locations
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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, Michigan
Henry Ford Transplant Institute Recruiting
Detroit, Michigan, United States, 48202
Contact: Dilip Moonka, MD       DMOONKA1@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   
Principal Investigator: Chandra Bhatti, MD         
United States, Washington
Division of Transplant Surgery, University of Washington Not yet recruiting
Seattle, Washington, United States, 98195
Contact: Martin I Montenovo, MD FACS    206-598-4834    martinm@uw.edu   
Principal Investigator: Martin I Montenovo, MD FACS         
Sub-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   
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   
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 Not yet recruiting
London, United Kingdom, SE5 9NU
Contact: Alberto Sanchez-Fueyo, Professor       sanchez_fueyo@kcl.ac.uk   
Principal Investigator: Alberto Sanchez-Fueyo, MD, PhD         
Sponsors and Collaborators
University of Alberta
Investigators
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Principal Investigator: Philip F Halloran, MD, PhD University of Alberta

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Responsible Party: Philip Halloran, Distinguished Professor, University of Alberta
ClinicalTrials.gov Identifier: NCT03193151     History of Changes
Other Study ID Numbers: ATAGC04
First Posted: June 20, 2017    Key Record Dates
Last Update Posted: June 21, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Philip Halloran, University of Alberta:
Liver transplant
global gene expression
molecular diagnostics

Additional relevant MeSH terms:
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Liver Diseases
Digestive System Diseases
Liver Extracts
Hematinics