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
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.
The current standard for assessment of rejection in lung transplants is a transbronchial biopsy (TBB) interpreted by histology according to International Society of Heart and Lung Transplantation (ISHLT) guidelines. This has considerable error rates, many due to the high disagreement among pathologists. There is a need for new methods of assessing TBBs. In addition, the emergence of blood donor-derived cell-free DNA (dd-cfDNA) measurement offers a new opportunity for screening for rejection. To address the unmet need for precision and accuracy, the Alberta Transplant Applied Genomics Centre (ATAGC, University of Alberta) has developed a new diagnostic system - the Molecular Microscope® Diagnostic System (MMDx), which uses microarrays to define the genome-wide gene expression and interpret lung transplant rejection and injury ((chronic lung allograft dysfunction (CLAD) related changes)). Now a new screening test is being introduced: the monitoring of dd-cfDNA released in the blood by the heart during rejection. The Natera Inc dd-cfDNA Prospera® test is based on the massively multiplex polymerase chain reaction that targets 13,392 single nucleotide polymorphisms and targeted sequences are quantified by Next Generation Sequencing. The Prospera® test has been done on kidney transplant recipients and detected "active rejection" and differentiated it from borderline rejection and no rejection. However, Prospera® test was not examined (the dd-cfDNA results) in lung transplant recipients. dd-cf-DNA test for lung transplants must now be calibrated against MMDx that is based on global gene expression, the new standard for biopsy interpretation. The present study will calibrate centrally measured (Natera Inc) dd-cfDNA levels obtained at the time of an indication or protocol biopsy against the MMDx measurements of T cell-mediated rejection (TCMR), antibody-mediated rejection (ABMR-like) and tissue injury. The present study will compare dd-cfDNA and MMDx in 600 prospectively collected biopsies for clinical indications and protocol, and accompanying 1800 blood samples, to calibrate the dd-cfDNA (Natera Inc.) levels against the MMDx biopsy diagnoses of TCMR, ABMR-like (and its stages), and injury, as well as central assessment of Human Leukocyte Antibody (HLA) antibody (One Lambda), interpreted centrally as donor specific antibody (DSA) based on the tissue typing results. This study is an extension of the INTERLUNG ClinicalTrials.gov identifier: NCT02812290 ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02581111 -
Naloxone for Optimizing Hypoxemia Of Lung Donors
|
Phase 2/Phase 3 | |
Recruiting |
NCT02177916 -
Patient Education Study to Determine Knowledge Acquisition in Patients Preparing to Undergo Lung Transplantation
|
N/A | |
Not yet recruiting |
NCT01394835 -
Safety and Efficacy of Inhaled Alpha-1 Antitrypsin in Preventing Bronchiolitis Obliterable Syndrome in Lung Transplant Recipients
|
Phase 2 | |
Not yet recruiting |
NCT01162148 -
Pulmonary Rehabilitation and Inspiratory Muscle Training (IMT) for Patients Following Lung Transplantation
|
N/A | |
Completed |
NCT01204970 -
Confocal Laser Micro-endoscopy in Chronic Obstructive Pulmonary Disease (COPD) and Lung Transplant Recipients
|
N/A | |
Active, not recruiting |
NCT00980967 -
Predictive Factors for Chronic Rejection in Lung Transplant Recipients: COLT Study
|
N/A | |
Completed |
NCT00531921 -
Effects of Donor and Recipient Genetic Expression on Heart, Lung, Liver, or Kidney Transplant Survival
|
N/A | |
Recruiting |
NCT00163696 -
Multi Breath Nitrogen Washout (MBNW) as a Measure of Small Airway Function in Patients With Respiratory Disease
|
N/A | |
Completed |
NCT00177684 -
Pharmacokinetic Profiles of Inhaled Lipid Complex Amphotericin B (Abelcet ®)
|
Phase 3 | |
Completed |
NCT00163891 -
Comparison of Two Chest Physiotherapy Protocols in Lung Transplant Recipients
|
N/A | |
Completed |
NCT03668483 -
Relation Between Muscle Strength With Exercise Capacity and Dyspnea in LTx
|
N/A | |
Not yet recruiting |
NCT02855372 -
Impact of the Age Difference Between the Donor and Recipient on the Morbidity and Mortality After Lung Transplantation. Study on a National Multicenter Cohort (COLT)
|
N/A | |
Completed |
NCT01212406 -
Vitamin D in Bronchiolitis Obliterans Syndrome
|
Phase 4 | |
Completed |
NCT01211509 -
Montelukast in Bronchiolitis Obliterans Syndrome
|
Phase 4 | |
Not yet recruiting |
NCT00808600 -
Empowerment of Lung and Heart-lung Transplant Patients
|
N/A | |
Completed |
NCT00553397 -
Live Lung Donor Retrospective Study
|
N/A | |
Completed |
NCT00402805 -
Improving the Humoral Response to Influenza Vaccine in Lung Transplant Recipients by an Intradermal Strategy
|
Phase 4 | |
Completed |
NCT00701922 -
Surveillance Study of Viral Infections Following Lung Transplantation
|
N/A | |
Terminated |
NCT00235651 -
Abelcet Radiotagging Protocol: Inhaled Lipid Complex Abelcet® in Lung Transplant Recipients
|
Phase 3 | |
Active, not recruiting |
NCT02936505 -
Clinical Study Evaluating Two Treatment Protocols for Immunosuppressive Drugs. Looking at 3-year Incidence of CLAD.
|
N/A |