Lung Transplantation Clinical Trial
Official title:
Trifecta-Lung cfDNA-MMDx Study: Comparing the Dd-cfDNA Test to MMDx Microarray Test and Central HLA Antibody Test
NCT number | NCT05837663 |
Other study ID # | Pro00048176 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | November 1, 2023 |
Est. completion date | December 2025 |
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.
Status | Recruiting |
Enrollment | 600 |
Est. completion date | December 2025 |
Est. primary completion date | November 2024 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: Adult, Older adult 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 |
Country | Name | City | State |
---|---|---|---|
Australia | The Alfred Hospital, Monash University | Melbourne | |
Austria | Department of Thoracic Surgery, Medical University of Vienna | Vienna | |
Canada | Alberta Transplant Applied Genomics Centre, University of Alberta | Edmonton | Alberta |
Canada | Department of Medicine, University of Alberta | Edmonton | Alberta |
Canada | University Health Network, Toronto General Hospital | Toronto | Ontario |
Czechia | Charles University/Hospital Motol | Prague | |
Czechia | Motol University Hospital, V Uvalu 84 | Prague |
Lead Sponsor | Collaborator |
---|---|
University of Alberta | Natera, Inc., One Lambda |
Australia, Austria, Canada, Czechia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 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. | 18 months | |
Primary | 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 as reported by MMDx. | 18 months | |
Primary | 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 as reported by MMDx. | 18 months | |
Primary | Report calibrated Prospera® test results for rejection | Report new dd-cfDNA test cut-off values for rejection | 6 months | |
Primary | Report calibrated Prospera® test results for lung injury | Report new DD-cfDNA test cut-off values for lung injury | 6 months | |
Secondary | 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.. | 6 months | |
Secondary | .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. | 6 months | |
Secondary | 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. | 6 months | |
Secondary | 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. | 6 months |
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