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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/NCT05837663
Registration number
NCT05837663
Ethics application status
Date submitted
3/04/2023
Date registered
1/05/2023
Date last updated
4/03/2024
Titles & IDs
Public title
Trifecta-Lung cfDNA-MMDx Study
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Scientific title
Trifecta-Lung 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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Pro00048176
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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:
Lung Transplantation
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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
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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 lung 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 lung injury in the biopsy as reported by MMDx.
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Timepoint [3]
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18 months
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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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Report new dd-cfDNA test cut-off values for rejection
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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 lung injury
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Assessment method [5]
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Report new DD-cfDNA test cut-off values for lung injury
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Timepoint [5]
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6 months
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Secondary outcome [1]
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Assessment of donor-specific antibody status
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Assessment method [1]
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Record and compare the DSA status (positive or negative) based on centralized and local HLA antibody to histology diagnoses..
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Timepoint [1]
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6 months
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Secondary outcome [2]
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.Estimate the false positive rate of dd-cfDNA for MMDx and histology in indication and protocol biopsies
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Assessment method [2]
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Calculate the sensitivity and specificity of dd-cfDNA for MMDx and histology diagnoses.
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Timepoint [2]
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6 months
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Secondary outcome [3]
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Determine whether calibrated dd-cfDNA blood test will replace biopsies
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Assessment method [3]
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Determine if dd-cfDNA test will avoid need for indication biopsy when transplant function deteriorates - yes or no. This will be based on the consensus between participating clinicians.
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Timepoint [3]
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6 months
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Secondary outcome [4]
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Determine whether calibrated dd-cfDNA blood test predicts the effect of treatment
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Assessment method [4]
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Determine the values for dd-cfDNA for grades of response to treatment: no change, partial response, complete resolution.
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Timepoint [4]
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6 months
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Eligibility
Key inclusion criteria
Adult, Older adult
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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?
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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, cancer patients and 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
1/11/2023
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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
1/12/2025
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Actual
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Sample size
Target
600
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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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The Alfred Hospital, Monash University - Melbourne
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Recruitment postcode(s) [1]
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- Melbourne
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Recruitment outside Australia
Country [1]
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Austria
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State/province [1]
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Vienna
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Country [2]
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Canada
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State/province [2]
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Alberta
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Country [3]
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Canada
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State/province [3]
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Ontario
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Country [4]
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Czechia
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State/province [4]
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Prague
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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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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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Country [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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Country [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 Demonstrate the Molecular Microscope® (MMDx) Diagnostic System results in
indication and protocol biopsies from lung transplants.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05837663
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Trial related presentations / publications
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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 Centre, 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 S Famulski, PhD DSc
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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/NCT05837663
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