NCT03193151

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.

Trial Health

83
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
19mo left

Started Dec 2017

Longer than P75 for all trials

Geographic Reach
5 countries

15 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress84%
Dec 2017Dec 2027

First Submitted

Initial submission to the registry

June 15, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 20, 2017

Completed
6 months until next milestone

Study Start

First participant enrolled

December 19, 2017

Completed
9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

November 17, 2025

Status Verified

November 1, 2025

Enrollment Period

9 years

First QC Date

June 15, 2017

Last Update Submit

November 13, 2025

Conditions

Liver Dysfunction

Keywords

Liver transplantglobal gene expressionmolecular diagnostics

Outcome Measures

Primary Outcomes (1)

  • Assign molecular scores (probability) of T cell mediated rejection, antibody mediated rejection in liver transplant biopsies, in a reference set of 100 biopsies

    Based on the reference set, create molecular classifier that predicts antibody mediated and T cell mediated rejection for next 200 biopsies

    two years

Secondary Outcomes (1)

  • Assign in real time (two working days upon biopsy receipt) molecular scores (probability) of T cell mediated rejection and antibody mediated rejection.

    1 year

Interventions

liver biopsyPROCEDURE

5 mm fragment of liver transplant biopsy taken for clinical indication

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • biopsy for clinical indications

You may not qualify if:

  • no consent, pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

University of California San Francisco, Transplant Research Unit

San Francisco, California, 94143, United States

COMPLETED

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

COMPLETED

University of Maryland School of Medicine

Baltimore, Maryland, 21201, United States

COMPLETED

Henry Ford Transplant Institute

Detroit, Michigan, 48202, United States

RECRUITING

Vanderbilt University Medical Center, Vanderbilt Transplant Center

Nashville, Tennessee, 37232, United States

WITHDRAWN

Baylor University Medical Center, Annette C. and Harold C. Simmons Transplant Institute

Dallas, Texas, 75246, United States

COMPLETED

Transplant Surgery, VCU Medical Center

Richmond, Virginia, 23298, United States

COMPLETED

Division of Transplant Surgery, University of Washington

Seattle, Washington, 98195, United States

COMPLETED

Centenary Institute of Cancer Medicine & Cell Biology, Royal Prince Alfred Hospital

Camperdown, NSW 2050, Australia

COMPLETED

University of Alberta, Laboratory Medicine and Pathology

Edmonton, Alberta, T6G 2R7, Canada

COMPLETED

Dep. of Nephrology, Transplantation & Internal Med., Samodzielny Publiczny Szpital Kliniczny im. A. Mieleckiego

Katowice, 40-027, Poland

COMPLETED

Independent Public Composite Regional Hospital

Szczecin, 71-455, Poland

COMPLETED

Warsaw Medical University, Jesus the Child Clinical Hospital

Warsaw, 02-005, Poland

COMPLETED

Warsaw Medical University, Independent Public Clinical Hospital

Warsaw, 02-097, Poland

COMPLETED

Institute for Liver Science, King's College London

London, SE5 9NU, United Kingdom

COMPLETED

Related Publications (5)

  • Madill-Thomsen KS, Halloran PF. Precision diagnostics in transplanted organs using microarray-assessed gene expression: concepts and technical methods of the Molecular Microscope(R) Diagnostic System (MMDx). Clin Sci (Lond). 2024 Jun 5;138(11):663-685. doi: 10.1042/CS20220530.

    PMID: 38819301BACKGROUND

  • Madill-Thomsen KS, Gauthier PT, Abouljoud M, Bhati C, Bruno D, Ciszek M, Durlik M, Feng S, Foroncewicz B, Grat M, Jurczyk K, Levitsky J, McCaughan G, Maluf D, Montano-Loza A, Moonka D, Mucha K, Myslak M, Perkowska-Ptasinska A, Piecha G, Reichman T, Tronina O, Wawrzynowicz-Syczewska M, Zeair S, Halloran PF. Defining an NK Cell-enriched Rejection-like Phenotype in Liver Transplant Biopsies From the INTERLIVER Study. Transplantation. 2025 Aug 1;109(8):1367-1382. doi: 10.1097/TP.0000000000005269. Epub 2025 Jan 9.

    PMID: 39780312RESULT

  • Madill-Thomsen K, Abouljoud M, Bhati C, Ciszek M, Durlik M, Feng S, Foroncewicz B, Francis I, Grat M, Jurczyk K, Klintmalm G, Krasnodebski M, McCaughan G, Miquel R, Montano-Loza A, Moonka D, Mucha K, Myslak M, Paczek L, Perkowska-Ptasinska A, Piecha G, Reichman T, Sanchez-Fueyo A, Tronina O, Wawrzynowicz-Syczewska M, Wiecek A, Zieniewicz K, Halloran PF. The molecular diagnosis of rejection in liver transplant biopsies: First results of the INTERLIVER study. Am J Transplant. 2020 Aug;20(8):2156-2172. doi: 10.1111/ajt.15828. Epub 2020 Apr 9.

    PMID: 32090446RESULT

  • Madill-Thomsen KS, Abouljoud M, Bhati C, Ciszek M, Durlik M, Feng S, Foroncewicz B, Francis I, Grat M, Jurczyk K, Klintmalm G, Krasnodebski M, McCaughan G, Miquel R, Montano-Loza A, Moonka D, Mucha K, Myslak M, Paczek L, Perkowska-Ptasinska A, Piecha G, Reichman T, Sanchez-Fueyo A, Tronina O, Wawrzynowicz-Syczewska M, Wiecek A, Zieniewicz K, Halloran PF. The molecular phenotypes of injury, steatohepatitis, and fibrosis in liver transplant biopsies in the INTERLIVER study. Am J Transplant. 2022 Mar;22(3):909-926. doi: 10.1111/ajt.16890. Epub 2021 Dec 3.

    PMID: 34780106RESULT

  • Halloran PF. Integrating molecular and histologic interpretation of transplant biopsies. Clin Transplant. 2021 Apr;35(4):e14244. doi: 10.1111/ctr.14244. Epub 2021 Feb 17. No abstract available.

    PMID: 33595110DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Biopsy extract containing RNA

MeSH Terms

Conditions

Liver Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

  • Philip F Halloran, MD, PhD

    University of Alberta

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Konrad S Famulski, PhD

CONTACT

1 780 492 1725konrad@ualberta.ca

Robert Polakowski, PhD

CONTACT

1 780 492 5091polakows@ualberta.ca

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Distinguished Professor

Study Record Dates

First Submitted

June 15, 2017

First Posted

June 20, 2017

Study Start

December 19, 2017

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2027

Last Updated

November 17, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

PL(4)AU(1)GB(1)US(8)CA(1)