Ignite Creation Date:
2024-05-06 @ 6:55 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05837663
Status:
RECRUITING
Last Update Posted:
2024-03-04
First Post:
2023-04-03
Brief Title:
Trifecta-Lung cfDNA-MMDx Study
Sponsor:
University of Alberta
Organization:
University of Alberta
Study Overview
Official Title:
Trifecta-Lung cfDNA-MMDx Study Comparing the Dd-cfDNA Test to MMDx Microarray Test and Central HLA Antibody Test
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
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 13392 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 ClinicalTrialsgov identifier NCT02812290
Currently the study accrued 100 TBBs and 64 corresponding blood samples for dd-cfDNA test
Currently the study accrued 100 TBBs and 64 corresponding blood samples for dd-cfDNA test
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None