Assessment of Donor Derived Cell Free DNA and Utility in Lung Transplantation

Not Applicable

Terminated

Conditions: Lung Transplant Failure and Rejection

Interventions: Diagnostic Test: Allosure

Registration Number: NCT04318587

Lead Sponsor: Pablo Sanchez

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 40

Inclusion Criteria

Participant is willing and able to give informed consent for participation in the study.
Male or Female, aged 18 years or above.
Denovo lung transplant recipient
Ability to understand written and spoken English

Exclusion Criteria

Previous transplant or multi-organ transplant
Unable to have blood draw for medical reason

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Allosure Arm	Allosure	All subjects will be in arm one and will have AlloSure blood draws at multiple time points.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Primary Graft Dysfunction/Allograft Rejection 72 Hours Post Transplant	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.
Number of Participants With Allograft Rejection 6 Months Post Transplant	6 months post transplant	Number of participants that experienced allograft rejection determined by evaluation of biopsy taken during bronchoscopy.
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 24 Hours Post Transplant	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.
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 9 Weeks Post Transplant	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.
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 4 Months Post Transplant	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.
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 11 Months Post Transplant	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.
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 12 Months Post Transplant	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.
Number of Participants With Allograft Rejection 3 Months Post Transplant	3 months post transplant	Number of participants that experienced allograft rejection determined by evaluation of biopsy taken during bronchoscopy.
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) Pre-Transplant	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
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 72 Hours Post Transplant	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.
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 2 Weeks Post Transplant	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
Number of Participants With Primary Graft Dysfunction/Allograft Rejection 24 Hours Post Transplant	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.
Number of Participants With Primary Graft Dysfunction/Allograft Rejection 48 Hours Post Transplant	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.
Number of Participants With Allograft Rejection 9 Months Post Transplant	9 months post transplant	Number of participants that experienced allograft rejection determined by evaluation of biopsy taken during bronchoscopy.
Number of Participants With Allograft Rejection 12 Months Post Transplant	12 months post transplant	Number of participants that experienced allograft rejection determined by evaluation of biopsy taken during bronchoscopy.
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 10 Weeks Post Transplant	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.
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 12 Weeks Post Transplant	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.
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 5 Months Post Transplant	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.
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 6 Months Post Transplant	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.
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 7 Months Post Transplant	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.
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 8 Months Post Transplant	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.
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 48 Hours Post Transplant	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.
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 1 Week Post Transplant	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.
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 3 Weeks Post Transplant	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.
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 4 Weeks Post Transplant	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.
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 5 Weeks Post Transplant	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.
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 7 Weeks Post Transplant	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.
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 6 Weeks Post Transplant	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.
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 8 Weeks Post Transplant	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.
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 11 Weeks Post Transplant	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.
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 10 Months Post Transplant	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.
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 9 Months Post Transplant	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants That Experienced Graft Failure or Death Within One Year Post Transplant	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.