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

Lung Transplant Failure and Rejection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04318587
• Other study ID #: STUDY19090098
• Status: Terminated
• Phase: N/A
• Start date: June 29, 2020
• Est. completion date: December 30, 2023

Study information

• Verified date: March 2024
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: December 30, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Transplant Failure and Rejection

Intervention

Diagnostic Test:
• Allosure
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.

Locations

Country	Name	City	State
United States	UPMC Presbyterian	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Pablo Sanchez	CareDx

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	24 hours post transplant
Primary	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.	48 hours post transplant
Primary	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.	72 hours post transplant
Primary	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.	3 months post transplant
Primary	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.	6 months post transplant
Primary	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.	9 months post transplant
Primary	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.	12 months post transplant
Primary	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	pre-transplant
Primary	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.	24 hours post-transplant
Primary	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.	48 hours post-transplant
Primary	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.	72 hours post-transplant
Primary	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.	1 week post-transplant
Primary	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	2 weeks post-transplant
Primary	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.	3 weeks post-transplant
Primary	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.	4 weeks post-transplant
Primary	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.	5 weeks post-transplant
Primary	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.	6 weeks post-transplant
Primary	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.	7 weeks post-transplant
Primary	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.	8 weeks post-transplant
Primary	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.	9 weeks post-transplant
Primary	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.	10 weeks post-transplant
Primary	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.	11 weeks post-transplant
Primary	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.	12 weeks post-transplant
Primary	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.	4 months post transplant
Primary	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.	5 months post transplant
Primary	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.	6 months post-transplant
Primary	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.	7 months post-transplant
Primary	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.	8 months post-transplant
Primary	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.	9 months post-transplant
Primary	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.	10 months post-transplant
Primary	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.	11 months post-transplant
Primary	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.	12 months post-transplant
Secondary	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.	one year post transplant