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Due to COVID and staffing shortages we decided to end the study with 40 participants instead of 50.
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| Name | Class |
|---|---|
| CareDx | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Allosure Arm | Experimental | All subjects will be in arm one and will have AlloSure blood draws at multiple time points. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Allosure | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| Number of Participants With Allograft Rejection 6 Months Post Transplant |
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pablo Sanchez, MD | Associate Program Director Residency Program | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UPMC Presbyterian | Pittsburgh | Pennsylvania | 15213 | United States |
Individual participant data that underlie the results reported in the article, after de-identification (text, tables, figures, and appendices)
Beginning 9 months and ending 36 months following article publication
Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | 24 hours post transplant |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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Not every patient had blood collected at the specified time points. Blood was missed at time of bronchoscopy or patient cancelled their bronchoscopy. 515 blood samples drawn and shipped to CareDx. 2 samples lost after they arrived at CareDx. Of the 513 samples assessed, we were not able to get the %dd-cfDNA data for 36 samples. This was due to sample quality and assay quality metrics. Hemolysis was the main reason for incomplete data.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Naomi Ryssel | University of Pittsburgh | 412-335-9688 | agostinonr@upmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 27, 2019 | Jan 2, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012059 | Rejection, Psychology |
| ID | Term |
|---|---|
| D012919 | Social Behavior |
| D001519 | Behavior |
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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
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|
Number of participants that experienced allograft rejection determined by evaluation of biopsy taken during bronchoscopy. |
| 6 months post transplant |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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. | Posted | Count of Participants | Participants | 48 hours post transplant |
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| 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. | Posted | Count of Participants | Participants | 72 hours post transplant |
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| 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. | Posted | Count of Participants | Participants | 3 months post transplant |
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| 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. | Posted | Count of Participants | Participants | 6 months post transplant |
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| 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. | Posted | Count of Participants | Participants | 9 months post transplant |
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| 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. | Posted | Count of Participants | Participants | 12 months post transplant |
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| 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 | Posted | Mean | Standard Deviation | %dd-cfDNA | pre-transplant |
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| 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. | Posted | Mean | Standard Deviation | %dd-cfDNA | 24 hours post-transplant |
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| 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. | Posted | Mean | Standard Deviation | %dd-cfDNA | 48 hours post-transplant |
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| 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. | Posted | Mean | Standard Deviation | %dd-cfDNA | 72 hours post-transplant |
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| 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. | Posted | Mean | Standard Deviation | %dd-cfDNA | 1 week post-transplant |
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| 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 | Posted | Mean | Standard Deviation | %dd-cfDNA | 2 weeks post-transplant |
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| 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. | Posted | Mean | Standard Deviation | %dd-cfDNA | 3 weeks post-transplant |
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| 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. | Posted | Mean | Standard Deviation | %dd-cfDNA | 4 weeks post-transplant |
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| 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. | Posted | Mean | Standard Error | %dd-cfDNA | 5 weeks post-transplant |
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| 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. | Posted | Mean | Standard Deviation | %dd-cfDNA | 6 weeks post-transplant |
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| 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. | Posted | Mean | Standard Deviation | %dd-cfDNA | 7 weeks post-transplant |
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| 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. | Posted | Mean | Standard Deviation | %dd-cfDNA | 8 weeks post-transplant |
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| 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. | Posted | Mean | Standard Deviation | %dd-cfDNA | 9 weeks post-transplant |
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| 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. | Posted | Mean | Standard Deviation | %dd-cfDNA | 10 weeks post-transplant |
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| 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. | Posted | Mean | Standard Deviation | %dd-cfDNA | 11 weeks post-transplant |
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| 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. | Posted | Mean | Standard Deviation | %dd-cfDNA | 12 weeks post-transplant |
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| 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. | Posted | Mean | Standard Deviation | %dd-cfDNA | 4 months post transplant |
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| 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. | Posted | Mean | Standard Deviation | %dd-cfDNA | 5 months post transplant |
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| 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. | Posted | Mean | Standard Deviation | %dd-cfDNA | 6 months post-transplant |
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| 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. | Posted | Mean | Standard Deviation | %dd-cfDNA | 7 months post-transplant |
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| 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. | Posted | Mean | Standard Deviation | %dd-cfDNA | 8 months post-transplant |
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| 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. | Posted | Mean | Standard Deviation | %dd-cfDNA | 9 months post-transplant |
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| 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. | Posted | Mean | Standard Deviation | %dd-cfDNA | 10 months post-transplant |
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| 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. | Posted | Mean | Standard Deviation | %dd-cfDNA | 11 months post-transplant |
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| 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. | Posted | Mean | Standard Deviation | %dd-cfDNA | 12 months post-transplant |
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| 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. | Posted | Count of Participants | Participants | one year post transplant |
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| 3 |
| 40 |
| 0 |
| 40 |
| 0 |
| 40 |
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