Lung Transplant Failure and Rejection Clinical Trial
Official title:
Assessment of Donor Derived Cell Free DNA and Utility in Lung Transplantation
Verified date | March 2024 |
Source | University of Pittsburgh |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | UPMC Presbyterian | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Pablo Sanchez | CareDx |
United States,
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 |
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