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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03193151




Registration number
NCT03193151
Ethics application status
Date submitted
15/06/2017
Date registered
20/06/2017
Date last updated
5/06/2024

Titles & IDs
Public title
Diagnostic and Therapeutic Applications of Microarrays in Liver Transplantation
Scientific title
Diagnostic and Therapeutic Applications of Microarrays in Liver Transplantation, a Multicenter Study
Secondary ID [1] 0 0
ATAGC04
Universal Trial Number (UTN)
Trial acronym
INTERLIVER
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Liver Dysfunction 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Cancer 0 0 0 0
Liver

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Surgery - liver biopsy

Treatment: Surgery: liver biopsy
5 mm fragment of liver transplant biopsy taken for clinical indication
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Assign molecular scores (probability) of T cell mediated rejection, antibody mediated rejection in liver transplant biopsies, in a reference set of 100 biopsies
Timepoint [1] 0 0
two years
Secondary outcome [1] 0 0
Assign in real time (two working days upon biopsy receipt) molecular scores (probability) of T cell mediated rejection and antibody mediated rejection.
Timepoint [1] 0 0
1 year

Eligibility
Key inclusion criteria
- biopsy for clinical indications
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- no consent, pregnant women

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/12/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2025
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Centenary Institute of Cancer Medicine & Cell Biology, Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 0 0
NSW 2050 - Camperdown
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Illinois
Country [3] 0 0
United States of America
State/province [3] 0 0
Maryland
Country [4] 0 0
United States of America
State/province [4] 0 0
Michigan
Country [5] 0 0
United States of America
State/province [5] 0 0
Tennessee
Country [6] 0 0
United States of America
State/province [6] 0 0
Texas
Country [7] 0 0
United States of America
State/province [7] 0 0
Virginia
Country [8] 0 0
United States of America
State/province [8] 0 0
Washington
Country [9] 0 0
Canada
State/province [9] 0 0
Alberta
Country [10] 0 0
Poland
State/province [10] 0 0
Katowice
Country [11] 0 0
Poland
State/province [11] 0 0
Szczecin
Country [12] 0 0
Poland
State/province [12] 0 0
Warszawa
Country [13] 0 0
United Kingdom
State/province [13] 0 0
London

Funding & Sponsors
Primary sponsor type
Other
Name
University of Alberta
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03193151
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.
Public notes

Contacts
Principal investigator
Name 0 0
Philip F Halloran, MD, PhD
Address 0 0
University of Alberta
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Konrad S Famulski, PhD
Address 0 0
Country 0 0
Phone 0 0
1 780 492 1725
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03193151