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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
Scientific title
Trifecta-Lung cfDNA-MMDx Study: Comparing the Dd-cfDNA Test to MMDx Microarray Test and Central HLA Antibody Test
Secondary ID [1] 0 0
Pro00048176
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lung Transplantation 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Calibration of Prospera® test for T cell mediated rejection
Timepoint [1] 0 0
18 months
Primary outcome [2] 0 0
Calibration of Prospera® test for antibody-mediated rejection
Timepoint [2] 0 0
18 months
Primary outcome [3] 0 0
Calibration of Prospera® test for lung injury
Timepoint [3] 0 0
18 months
Primary outcome [4] 0 0
Report calibrated Prospera® test results for rejection
Timepoint [4] 0 0
6 months
Primary outcome [5] 0 0
Report calibrated Prospera® test results for lung injury
Timepoint [5] 0 0
6 months
Secondary outcome [1] 0 0
Assessment of donor-specific antibody status
Timepoint [1] 0 0
6 months
Secondary outcome [2] 0 0
.Estimate the false positive rate of dd-cfDNA for MMDx and histology in indication and protocol biopsies
Timepoint [2] 0 0
6 months
Secondary outcome [3] 0 0
Determine whether calibrated dd-cfDNA blood test will replace biopsies
Timepoint [3] 0 0
6 months
Secondary outcome [4] 0 0
Determine whether calibrated dd-cfDNA blood test predicts the effect of treatment
Timepoint [4] 0 0
6 months

Eligibility
Key inclusion criteria
Adult, Older adult
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
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

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
1/11/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2025
Actual
Sample size
Target
600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
The Alfred Hospital, Monash University - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Vienna
Country [2] 0 0
Canada
State/province [2] 0 0
Alberta
Country [3] 0 0
Canada
State/province [3] 0 0
Ontario
Country [4] 0 0
Czechia
State/province [4] 0 0
Prague

Funding & Sponsors
Primary sponsor type
Other
Name
University of Alberta
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Natera, Inc.
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
One Lambda
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05837663
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Philip F Halloran, MD PhD
Address 0 0
Alberta Transplant Applied Genomics Centre, 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 DSc
Address 0 0
Country 0 0
Phone 0 0
1 780 782 9463
Fax 0 0
Email 0 0
konrad@ualberta.ca
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05837663