Diagnostic and Therapeutic Applications of Microarrays in Liver Transplantation (INTERLIVER)

February 1, 2024 updated by: Philip Halloran, University of Alberta

Diagnostic and Therapeutic Applications of Microarrays in Liver Transplantation, a Multicenter Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Thanks to increasing interest and support from participating centers, INTERLIVER has already processed 849 biopsies from 732 participants and will extend the Reference Set to 950 biopsies.

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Australia
      • Camperdown, Australia, NSW 2050
        • Recruiting
        • Centenary Institute of Cancer Medicine & Cell Biology, Royal Prince Alfred Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Geoffrey McCaughan, MD, PhD
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2R7
        • Recruiting
        • University of Alberta, Laboratory Medicine and Pathology
        • Contact:
        • Principal Investigator:
          • Aldo J Montano-Losa, MD PhD
        • Sub-Investigator:
          • Vince Bain, MD PhD
  • Poland
      • Katowice, Poland, 40-027
        • Recruiting
        • Dep. of Nephrology, Transplantation & Internal Med., Samodzielny Publiczny Szpital Kliniczny im. A. Mieleckiego
        • Contact:
        • Principal Investigator:
          • Grzegorz Piecha, MD
      • Szczecin, Poland, 71-455
        • Recruiting
        • Independent Public Composite Regional Hospital
        • Contact:
        • Principal Investigator:
          • Marta Marta Wawrzynowicz-Syczewska, Professor
        • Sub-Investigator:
          • Samir Zeair, MD PhD
      • Warszawa, Poland, 02-005
        • Recruiting
        • Warsaw Medical University, Jesus the Child Clinical Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Agnieszka Perkowska-Ptasinska, MD, PhD
        • Sub-Investigator:
          • Marek Pacholczyk, MD, PhD
      • Warszawa, Poland, 02-097
        • Recruiting
        • Warsaw Medical University, Independent Public Clinical Hospital
        • Contact:
        • Principal Investigator:
          • Krzysztof Zieniewicz, MD, PhD
        • Sub-Investigator:
          • Michal Grat, MD PhD
        • Sub-Investigator:
          • Maciej Krasnodebski, MD
  • United Kingdom
      • London, United Kingdom, SE5 9NU
        • Recruiting
        • Institute for Liver Science, King's College London
        • Contact:
        • Principal Investigator:
          • Alberto Sanchez-Fueyo, MD, PhD
  • United States
    • California
      • San Francisco, California, United States, 94143
        • Recruiting
        • University of California San Francisco, Transplant Research Unit
        • Contact:
        • Principal Investigator:
          • Sandy Feng, MD, PhD
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Josh Levitsky, Prof
        • Sub-Investigator:
          • Sunil Kurian, PhD
        • Contact:
          • Prof
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Recruiting
        • University of Maryland School of Medicine
        • Contact:
        • Principal Investigator:
          • Stephen Gray, MD
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Transplant Institute
        • Contact:
        • Contact:
        • Principal Investigator:
          • Marwan Abouljoud, MD
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Not yet recruiting
        • Vanderbilt University Medical Center, Vanderbilt Transplant Center
        • Contact:
        • Principal Investigator:
          • Seth J Karp, MD, PhD
        • Sub-Investigator:
          • Roman Perri, MD
    • Texas
      • Dallas, Texas, United States, 75246
        • Completed
        • Baylor University Medical Center, Annette C. and Harold C. Simmons Transplant Institute
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Completed
        • Transplant Surgery, VCU Medical Center
    • Washington
      • Seattle, Washington, United States, 98195
        • Recruiting
        • Division of Transplant Surgery, University of Washington
        • Contact:
          • Catherine I Kling, MD MPH
          • Phone Number: 206-598-3753
          • Email: cekling@uw.edu
        • Principal Investigator:
          • Jorge Reyes, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

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.

Description

Inclusion Criteria:

  • biopsy for clinical indications

Exclusion Criteria:

  • no consent, pregnant women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
two years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alberta

Investigators

  • Principal Investigator: Philip F Halloran, MD, PhD, University of Alberta

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 19, 2017

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

June 15, 2017

First Submitted That Met QC Criteria

June 15, 2017

First Posted (Actual)

June 20, 2017

Study Record Updates

Last Update Posted (Estimated)

February 5, 2024

Last Update Submitted That Met QC Criteria

February 1, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ATAGC04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Liver Dysfunction

Clinical Trials on liver biopsy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kenya

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe