Lung Transplant Failure and Rejection
Conditions
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.
Interventions
DIAGNOSTIC_TESTAllosure
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.
Sponsors
CareDx
Pablo Sanchez
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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 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 3 Months Post Transplant | 3 months post transplant | Number of participants that experienced allograft rejection determined by evaluation of biopsy taken during bronchoscopy. |
| 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. |
| 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) 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) 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) 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) 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) 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) 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 |
| 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) 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) 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) 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) 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) 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) 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) 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) 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) 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) 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. |
| 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) 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Allosure Arm All subjects will be in arm one and will have AlloSure blood draws at multiple time points.
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. | 40 |
| Total | 40 |
Baseline characteristics
| Characteristic | Allosure Arm | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 14 Participants | — |
| Age, Categorical Between 18 and 65 years | 26 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 40 participants | — |
| Sex: Female, Male Female | 17 Participants | — |
| Sex: Female, Male Male | 23 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 3 / 40 |
| other Total, other adverse events | 0 / 40 |
| serious Total, serious adverse events | 0 / 40 |
Outcome results
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.
Time frame: 10 months post-transplant
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Allosure Arm | Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 10 Months Post Transplant | 0.67 %dd-cfDNA | Standard Deviation 0.61 |
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.
Time frame: 10 weeks post-transplant
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Allosure Arm | Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 10 Weeks Post Transplant | 0.74 %dd-cfDNA | Standard Deviation 0.49 |
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.
Time frame: 11 months post-transplant
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Allosure Arm | Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 11 Months Post Transplant | 0.67 %dd-cfDNA | Standard Deviation 0.39 |
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.
Time frame: 11 weeks post-transplant
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Allosure Arm | Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 11 Weeks Post Transplant | 0.89 %dd-cfDNA | Standard Deviation 0.49 |
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.
Time frame: 12 months post-transplant
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Allosure Arm | Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 12 Months Post Transplant | 0.56 %dd-cfDNA | Standard Deviation 0.83 |
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.
Time frame: 12 weeks post-transplant
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Allosure Arm | Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 12 Weeks Post Transplant | 1.04 %dd-cfDNA | Standard Deviation 1.01 |
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.
Time frame: 1 week post-transplant
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Allosure Arm | Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 1 Week Post Transplant | 5.08 %dd-cfDNA | Standard Deviation 2.3 |
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.
Time frame: 24 hours post-transplant
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Allosure Arm | Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 24 Hours Post Transplant | 15.4 %dd-cfDNA | Standard Deviation 4.5 |
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
Time frame: 2 weeks post-transplant
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Allosure Arm | Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 2 Weeks Post Transplant | 4.84 %dd-cfDNA | Standard Deviation 16.04 |
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.
Time frame: 3 weeks post-transplant
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Allosure Arm | Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 3 Weeks Post Transplant | 2.32 %dd-cfDNA | Standard Deviation 1.35 |
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.
Time frame: 48 hours post-transplant
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Allosure Arm | Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 48 Hours Post Transplant | 11.56 %dd-cfDNA | Standard Deviation 5.23 |
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.
Time frame: 4 months post transplant
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Allosure Arm | Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 4 Months Post Transplant | 0.85 %dd-cfDNA | Standard Deviation 1.04 |
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.
Time frame: 4 weeks post-transplant
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Allosure Arm | Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 4 Weeks Post Transplant | 2.58 %dd-cfDNA | Standard Deviation 2.09 |
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.
Time frame: 5 months post transplant
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Allosure Arm | Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 5 Months Post Transplant | 0.67 %dd-cfDNA | Standard Deviation 0.53 |
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.
Time frame: 5 weeks post-transplant
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Allosure Arm | Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 5 Weeks Post Transplant | 2.09 %dd-cfDNA | Standard Error 1.33 |
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.
Time frame: 6 months post-transplant
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Allosure Arm | Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 6 Months Post Transplant | 0.92 %dd-cfDNA | Standard Deviation 0.86 |
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.
Time frame: 6 weeks post-transplant
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Allosure Arm | Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 6 Weeks Post Transplant | 1.43 %dd-cfDNA | Standard Deviation 0.87 |
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.
Time frame: 72 hours post-transplant
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Allosure Arm | Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 72 Hours Post Transplant | 8.41 %dd-cfDNA | Standard Deviation 3.85 |
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.
Time frame: 7 months post-transplant
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Allosure Arm | Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 7 Months Post Transplant | 1.01 %dd-cfDNA | Standard Deviation 1.58 |
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.
Time frame: 7 weeks post-transplant
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Allosure Arm | Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 7 Weeks Post Transplant | 1.06 %dd-cfDNA | Standard Deviation 0.67 |
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.
Time frame: 8 months post-transplant
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Allosure Arm | Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 8 Months Post Transplant | 0.50 %dd-cfDNA | Standard Deviation 0.58 |
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.
Time frame: 8 weeks post-transplant
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Allosure Arm | Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 8 Weeks Post Transplant | 0.91 %dd-cfDNA | Standard Deviation 0.49 |
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.
Time frame: 9 months post-transplant
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Allosure Arm | Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 9 Months Post Transplant | 0.92 %dd-cfDNA | Standard Deviation 0.66 |
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.
Time frame: 9 weeks post-transplant
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Allosure Arm | Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 9 Weeks Post Transplant | 0.85 %dd-cfDNA | Standard Deviation 0.5 |
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
Time frame: pre-transplant
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Allosure Arm | Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) Pre-Transplant | 0.014 %dd-cfDNA | Standard Deviation 0.05 |
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.
Time frame: 12 months post transplant
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Allosure Arm | Number of Participants With Allograft Rejection 12 Months Post Transplant | 0 Participants |
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.
Time frame: 3 months post transplant
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Allosure Arm | Number of Participants With Allograft Rejection 3 Months Post Transplant | 6 Participants |
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.
Time frame: 6 months post transplant
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Allosure Arm | Number of Participants With Allograft Rejection 6 Months Post Transplant | 0 Participants |
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.
Time frame: 9 months post transplant
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Allosure Arm | Number of Participants With Allograft Rejection 9 Months Post Transplant | 0 Participants |
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.
Time frame: 24 hours post transplant
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Allosure Arm | Number of Participants With Primary Graft Dysfunction/Allograft Rejection 24 Hours Post Transplant | PGD 1 | 15 Participants |
| Allosure Arm | Number of Participants With Primary Graft Dysfunction/Allograft Rejection 24 Hours Post Transplant | PGD 2 | 2 Participants |
| Allosure Arm | Number of Participants With Primary Graft Dysfunction/Allograft Rejection 24 Hours Post Transplant | PGD 3 | 8 Participants |
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.
Time frame: 48 hours post transplant
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Allosure Arm | Number of Participants With Primary Graft Dysfunction/Allograft Rejection 48 Hours Post Transplant | PGD 1 | 19 Participants |
| Allosure Arm | Number of Participants With Primary Graft Dysfunction/Allograft Rejection 48 Hours Post Transplant | PGD 2 | 1 Participants |
| Allosure Arm | Number of Participants With Primary Graft Dysfunction/Allograft Rejection 48 Hours Post Transplant | PGD 3 | 10 Participants |
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.
Time frame: 72 hours post transplant
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Allosure Arm | Number of Participants With Primary Graft Dysfunction/Allograft Rejection 72 Hours Post Transplant | PGD 3 | 11 Participants |
| Allosure Arm | Number of Participants With Primary Graft Dysfunction/Allograft Rejection 72 Hours Post Transplant | PGD 1 | 15 Participants |
| Allosure Arm | Number of Participants With Primary Graft Dysfunction/Allograft Rejection 72 Hours Post Transplant | PGD 2 | 1 Participants |
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.
Time frame: one year post transplant
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Allosure Arm | Number of Participants That Experienced Graft Failure or Death Within One Year Post Transplant | 0 Participants |