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

• Sponsor: Pablo Sanchez (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04318587
• Collaborator: CareDx (Industry)
• Enrollment: 50
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 38.1
• Patients Per Site Per Month: 1.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lung Transplant Failure and Rejection	Diagnostic Test: Allosure	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• 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 rejectionCorrelate 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
• Masking: None (Open Label)
• Primary Purpose: Screening
• Official Title: Assessment of Donor Derived Cell Free DNA and Utility in Lung Transplantation
• Actual Study Start Date: Jun 29, 2020
• Anticipated Primary Completion Date: Dec 31, 2022
• Anticipated Study Completion Date: Sep 1, 2023

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Allosure Arm All subjects will be in arm one and will have AlloSure blood draws at multiple time points.

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.

Outcome Measures

Primary Outcome Measures

1. primary graft dysfunction/allograft rejection [24 hours post transplant]

   incidence of dysfunction/rejection

2. primary graft dysfunction/allograft rejection [48 hours post transplant]

   incidence of dysfunction/rejection

3. primary graft dysfunction/allograft rejection [72 hours post transplant]

   incidence of dysfunction/rejection

4. primary graft dysfunction/allograft rejection [3 months post transplant]

   incidence of dysfunction/rejection

5. primary graft dysfunction/allograft rejection [6 months post transplant]

   incidence of dysfunction/rejection

6. primary graft dysfunction/allograft rejection [9 months post transplant]

   incidence of dysfunction/rejection

7. primary graft dysfunction/allograft rejection [12 months post transplant]

   incidence of dysfunction/rejection

8. Allosure dd-cDNA [pre-transplant]

   amount of dd-cDNA in recipient

9. Allosure dd-cDNA [24 hours post-transplant]

   amount of dd-cDNA in recipient

10. Allosure dd-cDNA [48 hours post-transplant]

    amount of dd-cDNA in recipient

11. Allosure dd-cDNA [72 hours post-transplant]

    amount of dd-cDNA in recipient

12. Allosure dd-cDNA [1 week post-transplant]

    amount of dd-cDNA in recipient

13. Allosure dd-cDNA [2 weeks post-transplant]

    amount of dd-cDNA in recipient

14. Allosure dd-cDNA [3 weeks post-transplant]

    amount of dd-cDNA in recipient

15. Allosure dd-cDNA [4 weeks post-transplant]

    amount of dd-cDNA in recipient

16. Allosure dd-cDNA [5 weeks post-transplant]

    amount of dd-cDNA in recipient

17. Allosure dd-cDNA [6 weeks post-transplant]

    amount of dd-cDNA in recipient

18. Allosure dd-cDNA [7 weeks post-transplant]

    results of Allosure

19. Allosure dd-cDNA [8 weeks post-transplant]

    amount of dd-cDNA in recipient

20. Allosure dd-cDNA [9 weeks post-transplant]

    amount of dd-cDNA in recipient

21. Allosure dd-cDNA [10 weeks post-transplant]

    amount of dd-cDNA in recipient

22. Allosure dd-cDNA [11 weeks post-transplant]

    amount of dd-cDNA in recipient

23. Allosure dd-cDNA [12 weeks post-transplant]

    amount of dd-cDNA in recipient

24. Allosure dd-cDNA [6 months post-transplant]

    results of Allosure

25. Allosure dd-cDNA [7 months post-transplant]

    amount of dd-cDNA in recipient

26. Allosure dd-cDNA [8 months post-transplant]

    amount of dd-cDNA in recipient

27. Allosure dd-cDNA [9 months post-transplant]

    results of Allosure

28. Allosure dd-cDNA [10 months post-transplant]

    amount of dd-cDNA in recipient

29. Allosure dd-cDNA [11 months post-transplant]

    amount of dd-cDNA in recipient

30. Allosure dd-cDNA [12 months post-transplant]

    amount of dd-cDNA in recipient

Secondary Outcome Measures

1. Assessment of AlloSure in the predictive and prognostic value of diagnosing CLAD/allograft failure/premature death [From date of transplant until the date of graft failure or date of death from any cause, whichever came first, assessed up to 60 months.]

   incidence of biopsy, PFT, and AlloSure results that are correlated

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UPMC Presbyterian	Pittsburgh	Pennsylvania	United States	15213

Sponsors and Collaborators

• Pablo Sanchez
• CareDx

Investigators

• Principal Investigator: Pablo Sanchez, MD, Associate Program Director Residency Program

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Pablo Sanchez, Vice Chair, Benign Lung Diseases Surgical Director, Lung Transplant and ECMO, Director, Lung Transplant Research and ELVP Program, University of Pittsburgh
• ClinicalTrials.gov Identifier: NCT04318587
• Other Study ID Numbers: STUDY19090098
• First Posted: Mar 24, 2020
• Last Update Posted: Jun 2, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

Study Results

No Results Posted as of Jun 2, 2022