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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/NCT04707872
Registration number
NCT04707872
Ethics application status
Date submitted
11/01/2021
Date registered
13/01/2021
Date last updated
5/06/2024
Titles & IDs
Public title
Trifecta-Heart cfDNA-MMDx Study
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Scientific title
Trifecta-Heart cfDNA-MMDX Study: Comparing the DD-cfDNA Test to MMDx Microarray Test and Central HLA Antibody Test
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Secondary ID [1]
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ATAGC06
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Heart Transplant Rejection
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Condition category
Condition code
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
Diagnosis / Prognosis - MMDx diagnostic test
Diagnosis / Prognosis - Prospera
Diagnosis / Prognosis - HLA antibody
Heart transplant protocol and for cause biopsies - The study population includes patients with a functioning heart transplant undergoing a biopsy for clinical indications as standard of care, or protocol biopsies of heart in high-risk patients, or follow-up after treatment.
Diagnosis / Prognosis: MMDx diagnostic test
Microarray test of gene expression in heart biopsies
Diagnosis / Prognosis: Prospera
Donor derived cell-free DNA in patient blood
Diagnosis / Prognosis: HLA antibody
Centralized measurement of HLA antibodies in patient blood
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Intervention code [1]
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Diagnosis / Prognosis
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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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Calibration of Prospera test for T cell-mediated rejection
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Assessment method [1]
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Set DD-cfDNA test cut-off values against the probability of T cell-mediated rejection in the biopsy as reported by MMDx. Calibration of DD-cfDNA test cut-off values against the probability of T cell-mediated rejection in the biopsy as reported by MMDx.
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Timepoint [1]
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18 months
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Primary outcome [2]
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Calibration of Prospera test for antibody-mediated rejection
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Assessment method [2]
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Set DD-cfDNA test cut-off values against the probability of antibody-mediated rejection in the biopsy as reported by MMDx.
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Timepoint [2]
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18 months
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Primary outcome [3]
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Calibration of Prospera test for heart injury
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Assessment method [3]
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Set DD-cfDNA test cut-off values against the probability of acute and chronic heart injury in the biopsy as reported by MMDx.
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Timepoint [3]
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18 month
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Primary outcome [4]
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Report calibrated Prospera test results for rejection
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Assessment method [4]
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Obtain clinicians feedback
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Timepoint [4]
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6 months
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Primary outcome [5]
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Report calibrated Prospera test results for heart injury
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Assessment method [5]
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Obtain clinicians feedback
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Timepoint [5]
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6 month
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Secondary outcome [1]
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Determine if Prospera blood test can replace heart biopsy test
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Assessment method [1]
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Obtain clinicians feedback
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Timepoint [1]
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6 month
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Secondary outcome [2]
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Determine if Prospera blood test can replace follow up heart biopsy
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Assessment method [2]
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Determine whether resolution of DD-cfDNA after treatment can monitor response to therapy and avoid follow-up biopsies
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Timepoint [2]
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6 month
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Secondary outcome [3]
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Assessment of donor-specific antibody status
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Assessment method [3]
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Report and compare the DSA status based on centralized and local HLA antibody measurement.
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Timepoint [3]
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6 months
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Eligibility
Key inclusion criteria
- All heart transplant recipients undergoing a biopsy for clinical indications and
protocol biopsies, as determined by their physician or surgeon, will be eligible to
enroll in the study.
- Patients are enrolled based on standard of care biopsies, including surveillance
biopsies in high-risk patients, with informed consent.
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Minimum age
No limit
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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
- Patients will be excluded from the study if they decline participation
- Are unable to give informed consent.
- Recipients of multiple organs.
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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
1/06/2021
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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
1/07/2025
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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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Cardiac Transplantation Laboratory, The Victor Chang Cardiac Research Institute - Darlinghurst
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Recruitment postcode(s) [1]
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NSW 2010 - Darlinghurst
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Arkansas
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United States of America
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California
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United States of America
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New Jersey
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United States of America
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New York
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Country [5]
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United States of America
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Texas
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Country [6]
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United States of America
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Utah
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Austria
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Vienna
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Country [8]
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Canada
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Alberta
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Country [9]
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Czechia
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Prague
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Italy
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Bologna
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Poland
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State/province [11]
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Zabrze
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Country [12]
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Spain
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State/province [12]
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La Coruna
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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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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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Natera, Inc.
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Address [1]
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Other collaborator category [2]
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Other
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Name [2]
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One Lambda
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Address [2]
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Ethics approval
Ethics application status
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Summary
Brief summary
Demonstrate the relationship between DD-cfDNA levels and HLA antibodies in blood transplant
recipient and the Molecular Microscope® (MMDx) Diagnostic System results in indication and
protocol biopsies from heart transplants.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04707872
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Trial related presentations / publications
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.
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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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Alberta Transplant Applied Genomics Center, University of Alberta
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Country
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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 Famulski, PhD
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Address
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Country
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Phone
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1 780 782 9463
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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
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04707872
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