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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03193151
Registration number
NCT03193151
Ethics application status
Date submitted
15/06/2017
Date registered
20/06/2017
Titles & IDs
Public title
Diagnostic and Therapeutic Applications of Microarrays in Liver Transplantation
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Scientific title
Diagnostic and Therapeutic Applications of Microarrays in Liver Transplantation, a Multicenter Study
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Secondary ID [1]
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ATAGC04
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Universal Trial Number (UTN)
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Trial acronym
INTERLIVER
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Liver Dysfunction
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Condition category
Condition code
Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Cancer
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Liver
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Treatment: Surgery - liver biopsy
Treatment: Surgery: liver biopsy
5 mm fragment of liver transplant biopsy taken for clinical indication
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Intervention code [1]
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Treatment: Surgery
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Assign molecular scores (probability) of T cell mediated rejection, antibody mediated rejection in liver transplant biopsies, in a reference set of 100 biopsies
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Assessment method [1]
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Based on the reference set, create molecular classifier that predicts antibody mediated and T cell mediated rejection for next 200 biopsies
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Timepoint [1]
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two years
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Secondary outcome [1]
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Assign in real time (two working days upon biopsy receipt) molecular scores (probability) of T cell mediated rejection and antibody mediated rejection.
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Assessment method [1]
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The molecular phenotype of a newly acquired sample predicts the histologic and clinical features of this sample when compared to the reference set.
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Timepoint [1]
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1 year
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Eligibility
Key inclusion criteria
* biopsy for clinical indications
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* no consent, pregnant women
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
19/12/2017
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/12/2026
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Actual
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Sample size
Target
300
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Centenary Institute of Cancer Medicine & Cell Biology, Royal Prince Alfred Hospital - Camperdown
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Recruitment postcode(s) [1]
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NSW 2050 - Camperdown
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Recruitment outside Australia
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United States of America
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State/province [1]
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California
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United States of America
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State/province [2]
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Illinois
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United States of America
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State/province [3]
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Maryland
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United States of America
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State/province [4]
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Michigan
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United States of America
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Tennessee
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United States of America
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Texas
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United States of America
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Virginia
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United States of America
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Washington
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Country [9]
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Canada
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State/province [9]
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Alberta
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Country [10]
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Poland
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State/province [10]
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Katowice
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Country [11]
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Poland
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State/province [11]
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Szczecin
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Country [12]
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Poland
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State/province [12]
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Warszawa
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Country [13]
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United Kingdom
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State/province [13]
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London
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Funding & Sponsors
Primary sponsor type
Other
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Name
University of Alberta
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT03193151
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Trial related presentations / publications
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. 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. 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. 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.
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Public notes
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Contacts
Principal investigator
Name
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Philip F Halloran, MD, PhD
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Address
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University of Alberta
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Konrad S Famulski, PhD
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Address
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Country
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Phone
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1 780 492 1725
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Type
Citations or Other Details
Journal
Madill-Thomsen K, Abouljoud M, Bhati C, Ciszek M, ...
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More Details
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Results not provided in
https://clinicaltrials.gov/study/NCT03193151