The use of Allosure to identify and quantify circulating donor-derived cell-free DNA to quantitate allograft injury in the early post-transplant period and determine its relationship to allograft failure.
Single Center Prospective Cohort Study on De-Novo Lung Transplant recipients. AlloSure will be drawn as part of routine blood draws and sent to CareDx for analysis of dd-cfDNA. All data will be collected and stored in the hospital EMR, this will be examined with the AlloSure results to correlate outcomes.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SCREENING
Masking
NONE
Enrollment
40
Blood is collected from the patient, packaged, and shipped at ambient temperature to CareDx for testing. Donor-derived cell-free DNA is measured via targeted amplification and sequencing of a set of carefully selected and validated SNPs. The AlloSure bioinformatics software calculates the percent dd-cfDNA in the sample tested and applies the QC criteria. The AlloSure results will be compared to the episodes of acute rejection diagnosed by transbronchial biopsy and BOS/CLAD diagnosed by spirometry in the subjects medical records. Transbronchial biopsies and spirometry are standard of care for lung transplant recipients.
UPMC Presbyterian
Pittsburgh, Pennsylvania, United States
Number of Participants With Primary Graft Dysfunction/Allograft Rejection 24 Hours Post Transplant
Primary Graft Dysfunction is measured using a combination of radiographic opacification and P:F ratio (ratio of partial pressure of oxygen related to fraction of inhaled oxygen). Grade 0: No opacifications on CXR Grade 1: Opacifications and P:F \> 300 Grade 2: Opacifications and P:F \>200, \< 300 Grade 3: Opacifications and P:F \< 200 If someone requires ECMO, they are automatically a grade 3.
Time frame: 24 hours post transplant
Number of Participants With Primary Graft Dysfunction/Allograft Rejection 48 Hours Post Transplant
Primary Graft Dysfunction is measured using a combination of radiographic opacification and P:F ratio (ratio of partial pressure of oxygen related to fraction of inhaled oxygen). Grade 0: No opacifications on CXR Grade 1: Opacifications and P:F \> 300 Grade 2: Opacifications and P:F \>200, \< 300 Grade 3: Opacifications and P:F \< 200 If someone requires ECMO, they are automatically a grade 3.
Time frame: 48 hours post transplant
Number of Participants With Primary Graft Dysfunction/Allograft Rejection 72 Hours Post Transplant
Primary Graft Dysfunction is measured using a combination of radiographic opacification and P:F ratio (ratio of partial pressure of oxygen related to fraction of inhaled oxygen). Grade 0: No opacifications on CXR Grade 1: Opacifications and P:F \> 300 Grade 2: Opacifications and P:F \>200, \< 300 Grade 3: Opacifications and P:F \< 200 If someone requires ECMO, they are automatically a grade 3.
Time frame: 72 hours post transplant
Number of Participants With Allograft Rejection 3 Months Post Transplant
Number of participants that experienced allograft rejection determined by evaluation of biopsy taken during bronchoscopy.
Time frame: 3 months post transplant
Number of Participants With Allograft Rejection 6 Months Post Transplant
Number of participants that experienced allograft rejection determined by evaluation of biopsy taken during bronchoscopy.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 6 months post transplant
Number of Participants With Allograft Rejection 9 Months Post Transplant
Number of participants that experienced allograft rejection determined by evaluation of biopsy taken during bronchoscopy.
Time frame: 9 months post transplant
Number of Participants With Allograft Rejection 12 Months Post Transplant
Number of participants that experienced allograft rejection determined by evaluation of biopsy taken during bronchoscopy.
Time frame: 12 months post transplant
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) Pre-Transplant
dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells. Amount of Allosure Donor Derived Cell Free DNA (dd-cDNA) Pre-Transplant
Time frame: pre-transplant
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 24 Hours Post Transplant
dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.
Time frame: 24 hours post-transplant
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 48 Hours Post Transplant
dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.
Time frame: 48 hours post-transplant
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 72 Hours Post Transplant
dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.
Time frame: 72 hours post-transplant
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 1 Week Post Transplant
dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.
Time frame: 1 week post-transplant
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 2 Weeks Post Transplant
dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells. Amount of Allosure Donor Derived Cell Free DNA (dd-cDNA) 2 Weeks Post Transplant
Time frame: 2 weeks post-transplant
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 3 Weeks Post Transplant
dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.
Time frame: 3 weeks post-transplant
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 4 Weeks Post Transplant
dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.
Time frame: 4 weeks post-transplant
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 5 Weeks Post Transplant
dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.
Time frame: 5 weeks post-transplant
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 6 Weeks Post Transplant
dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.
Time frame: 6 weeks post-transplant
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 7 Weeks Post Transplant
dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.
Time frame: 7 weeks post-transplant
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 8 Weeks Post Transplant
dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.
Time frame: 8 weeks post-transplant
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 9 Weeks Post Transplant
dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.
Time frame: 9 weeks post-transplant
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 10 Weeks Post Transplant
dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.
Time frame: 10 weeks post-transplant
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 11 Weeks Post Transplant
dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.
Time frame: 11 weeks post-transplant
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 12 Weeks Post Transplant
dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.
Time frame: 12 weeks post-transplant
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 4 Months Post Transplant
dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.
Time frame: 4 months post transplant
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 5 Months Post Transplant
dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.
Time frame: 5 months post transplant
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 6 Months Post Transplant
dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.
Time frame: 6 months post-transplant
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 7 Months Post Transplant
dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.
Time frame: 7 months post-transplant
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 8 Months Post Transplant
dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.
Time frame: 8 months post-transplant
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 9 Months Post Transplant
dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.
Time frame: 9 months post-transplant
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 10 Months Post Transplant
dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.
Time frame: 10 months post-transplant
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 11 Months Post Transplant
dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.
Time frame: 11 months post-transplant
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 12 Months Post Transplant
dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.
Time frame: 12 months post-transplant
Number of Participants That Experienced Graft Failure or Death Within One Year Post Transplant
The number of participants that were diagnosed as having chronic lung allograft dysfunction (CLAD), needed re-transplanted or died before 1 year post transplant.
Time frame: one year post transplant