Trifecta-Lung cfDNA-MMDx Study
ConditionLung Transplantation
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Alberta
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial population
All adult lung transplant recipients undergoing indication biopsy for suspected graft dysfunction will be eligible.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Calibration of Prospera® test for T cell mediated rejection
Set dd-cfDNA test cut-off values against the probability of T cell-mediated rejection in the biopsy (TBB and 3BMB) 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.
Time frame
18 months2
Calibration of Prospera® test for antibody-mediated rejection
Set dd-cfDNA test cut-off values against the probability of antibody-mediated rejection in the biopsy (TBB and 3BMB) as reported by MMDx.
Time frame
18 months3
Calibration of Prospera® test for lung injury
Set dd-cfDNA test cut-off values against the probability of acute and chronic lung injury in the biopsy (TBB and 3BMB)as reported by MMDx.
Time frame
18 months4
Report calibrated Prospera® test results for rejection
Report new dd-cfDNA test cut-off values for rejection
Time frame
6 monthsSecondary outcomes
1
Assessment of donor-specific antibody status
Record and compare the DSA status (positive or negative) based on centralized and local HLA antibody to histology diagnoses..
Time frame
6 months2
.Estimate the false positive rate of dd-cfDNA for MMDx and histology in indication and protocol biopsies
Calculate the sensitivity and specificity of dd-cfDNA for MMDx and histology diagnoses.
Time frame
6 months3
Determine whether calibrated dd-cfDNA blood test will replace biopsies
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.
Time frame
6 months4
Determine whether calibrated dd-cfDNA blood test predicts the effect of treatment
Determine the values for dd-cfDNA for grades of response to treatment: no change, partial response, complete resolution.
Time frame
6 monthsSponsors and contacts
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Source ClinicalTrials.gov