Clinical trial NCT04318587: Assessment of Donor Derived Cell Free DNA and Utility in Lung Transplantation
Official title: Assessment of Donor Derived Cell Free DNA and Utility in Lung Transplantation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Lung Transplant Failure and Rejection
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: CareDx
First posted: 2020-03-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Correlate donor DNA in blood samples to episodes of Acute rejection diagnosed by transbronchial biopsy and BOS/CLAD diagnosed by spirometry

From this correlation we hope to be able to develop a miniMally invasive test ( blood sample) that can predict or correlate acute and or chronic rejection
Primary purpose: SCREENING

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Primary Graft Dysfunction/Allograft Rejection 24 Hours Post Transplant
timeFrame: 24 hours post transplant
measure: Number of Participants With Primary Graft Dysfunction/Allograft Rejection 48 Hours Post Transplant
timeFrame: 48 hours post transplant
measure: Number of Participants With Primary Graft Dysfunction/Allograft Rejection 72 Hours Post Transplant
timeFrame: 72 hours post transplant
measure: Number of Participants With Allograft Rejection 3 Months Post Transplant
timeFrame: 3 months post transplant
measure: Number of Participants With Allograft Rejection 6 Months Post Transplant
timeFrame: 6 months post transplant
measure: Number of Participants With Allograft Rejection 9 Months Post Transplant
timeFrame: 9 months post transplant
measure: Number of Participants With Allograft Rejection 12 Months Post Transplant
timeFrame: 12 months post transplant
measure: Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) Pre-Transplant
timeFrame: pre-transplant
measure: Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 24 Hours Post Transplant
timeFrame: 24 hours post-transplant
measure: Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 48 Hours Post Transplant
timeFrame: 48 hours post-transplant
measure: Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 72 Hours Post Transplant
timeFrame: 72 hours post-transplant
measure: Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 1 Week Post Transplant
timeFrame: 1 week post-transplant
measure: Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 2 Weeks Post Transplant
timeFrame: 2 weeks post-transplant
measure: Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 3 Weeks Post Transplant
timeFrame: 3 weeks post-transplant
measure: Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 4 Weeks Post Transplant
timeFrame: 4 weeks post-transplant
measure: Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 5 Weeks Post Transplant
timeFrame: 5 weeks post-transplant
measure: Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 6 Weeks Post Transplant
timeFrame: 6 weeks post-transplant
measure: Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 7 Weeks Post Transplant
timeFrame: 7 weeks post-transplant
measure: Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 8 Weeks Post Transplant
timeFrame: 8 weeks post-transplant
measure: Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 9 Weeks Post Transplant
timeFrame: 9 weeks post-transplant
measure: Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 10 Weeks Post Transplant
timeFrame: 10 weeks post-transplant
measure: Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 11 Weeks Post Transplant
timeFrame: 11 weeks post-transplant
measure: Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 12 Weeks Post Transplant
timeFrame: 12 weeks post-transplant
measure: Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 4 Months Post Transplant
timeFrame: 4 months post transplant
measure: Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 5 Months Post Transplant
timeFrame: 5 months post transplant
measure: Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 6 Months Post Transplant
timeFrame: 6 months post-transplant
measure: Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 7 Months Post Transplant
timeFrame: 7 months post-transplant
measure: Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 8 Months Post Transplant
timeFrame: 8 months post-transplant
measure: Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 9 Months Post Transplant
timeFrame: 9 months post-transplant
measure: Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 10 Months Post Transplant
timeFrame: 10 months post-transplant
measure: Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 11 Months Post Transplant
timeFrame: 11 months post-transplant
measure: Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 12 Months Post Transplant
timeFrame: 12 months post-transplant
Secondary outcomes:
measure: Number of Participants That Experienced Graft Failure or Death Within One Year Post Transplant
timeFrame: one year post transplant
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC Presbyterian
state: Pennsylvania
Study officials:
affiliation: Associate Program Director Residency Program
name: Pablo Sanchez, MD
role: PRINCIPAL_INVESTIGATOR
References: