Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Diagnostic and Therapeutic Applications of Microarrays in Heart Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02670408
Recruitment Status : Recruiting
First Posted : February 1, 2016
Last Update Posted : June 26, 2020
Sponsor:
Information provided by (Responsible Party):
Philip Halloran, University of Alberta

Tracking Information
First Submitted Date January 22, 2016
First Posted Date February 1, 2016
Last Update Posted Date June 26, 2020
Study Start Date January 2016
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 22, 2017)
Assign molecular scores (probability) of T cell mediated rejection, antibody mediated rejection in heart transplant biopsies, in a reference set of 200 biopsies [ Time Frame: 2 years ]
Create a molecular classifier that predicts antibody mediated and T cell mediated rejection, based on the archetypal analysis.
Original Primary Outcome Measures
 (submitted: January 27, 2016)
Assign molecular scores (probability) of T cell mediated rejection, antibody mediated rejection in heart transplant biopsies, in a reference set of 200 biopsies [ Time Frame: 2 years ]
Create molecular classifier that predicts antibody mediated and T cell mediated rejection
Change History
Current Secondary Outcome Measures
 (submitted: January 27, 2016)
Assign in real time (three 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Diagnostic and Therapeutic Applications of Microarrays in Heart Transplantation
Official Title Diagnostic and Therapeutic Applications of Microarrays in Heart Transplantation, a Multicenter Study (INTERHEART)
Brief Summary Demonstrate the impact of the Molecular Microscope Diagnostic System as the standard of care for heart transplant patients.
Detailed Description The current standard for biopsy-based diagnoses of rejection of heart transplants is the ISHLT classification from 2004, which represents a widely-used international consensus, based on morphological criteria of the cellular infiltrate within the myocardial specimen system with certainties and some arbitrary and blurred parameters. Recent data-driven approaches using molecular and conventional technologies indicate that this system produces incorrect diagnoses with potential 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 heart transplant endomyocardial biopsies (EMBs). The present study will develop a Reference Set of EMB, adapt the MMDx™ system to assess and report EMBs; and validate and refine this system in 900 unselected prospectively collected for clinical indications and a standard of care EMBs 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. We refine now our MMDx system using a new type of analysis (see primary outcome) and the resulting MMDx report. Currently, INTERHEART recruited 1629 biopsies from 792 patients.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Biopsy extract containing RNA
Sampling Method Non-Probability Sample
Study Population This study aims to recruit 1200 biopsies from heart transplant patients for clinical indications and the standard of care biopsies.
Condition Cardiac Transplant Disorder
Intervention Procedure: Endomyocardial biopsy
One of several endomyocardial biopsy bites taken as the standard of care. We are asking now for two endomyocardial biopsy bites, to determine tissue sampling variability.
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: November 17, 2017)
900
Original Estimated Enrollment
 (submitted: January 27, 2016)
300
Estimated Study Completion Date December 2021
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • biopsy for clinical indications

Exclusion Criteria:

  • no consent
  • pregnant women
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Konrad S Famulski, PhD 1 7804921725 konrad@ualberta.ca
Contact: Robert Polakowski, PhD 1780 492 5091 polakows@ualberta.ca
Listed Location Countries Australia,   Austria,   Canada,   France,   Italy,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02670408
Other Study ID Numbers ATAGC 002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Philip Halloran, University of Alberta
Study Sponsor University of Alberta
Collaborators Not Provided
Investigators
Principal Investigator: Philip F Halloran, MD PhD University of Alberta
PRS Account University of Alberta
Verification Date June 2020