Diagnostic and Therapeutic Applications of Microarrays in Liver Transplantation
ConditionLiver Dysfunction
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Alberta
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
biopsy for clinical indications
Disqualifiers
no consent, pregnant women
Trial population
This study aims to recruit 300 biopsies from liver transplant patients for clinical indications and the standard of care biopsies.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
liver biopsy
Procedure/Surgery5 mm fragment of liver transplant biopsy taken for clinical indication
Treatment groups
No treatment groups listed
Trial outcomes
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
Time frame
two yearsSecondary outcomes
1
Assign in real time (two working days upon biopsy receipt) molecular scores (probability) of T cell mediated rejection and antibody mediated rejection.
The molecular phenotype of a newly acquired sample predicts the histologic and clinical features of this sample when compared to the reference set.
Time frame
1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov